Esstech, Inc. develops and manufactures advanced materials for many biomedical fields including dental materials. In their range of products are various monomers, initiators, silanated glass etc. for resin-based composites and adhesive systems. The latest research by or using Esstech's products includes studies on physical properties of new low shrink resin , optimizing the degee of conversion and certain physical properties of various BisGMA/BisEMA/TEGDMA formulations , optimizing silanated glass , developing a high molecular mass monomer to substitute HEMA etc.
For more information, check out their website and blog.
Esstech, Inc. will be present at the IADR/AADR General Session in Barcelona, Spain (14-17 July 2010) and I really look forward to meeting their representatives, hoping that we could establish scientific collaboration.
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Showing posts with label Research. Show all posts
Showing posts with label Research. Show all posts
Thursday, 29 April 2010
Thursday, 12 November 2009
Nano-filled resin-modified glass-ionomer cement: "nano-ionomer" Ketac N100
In addition to conventional and resin-modified glass-ionomer cements, a nano-filled resin-modified glass ionomer cement, or “nano-ionomer”, was developed by 3M ESPE a couple of years ago – Ketac N100.
It is stated by the manufacturer that indications for the use of this nano-ionomer include primary teeth restorations, small Class I, Class III and IV, temporary restorations, filling defects and undercuts, “sandwich” technique with resin-based composites, core build-ups with min 50% of the remaining tooth for support.
The nano-ionomer is based on the acrylic and itaconic acid copolymers necessary for the glass-ionomer reaction with fluoroaluminosilicate (FAS) glass and water. The nano-ionomer also contains a blend of resin monomers, BisGMA, TEGDMA, PEGDMA and HEMA which polymerize via the free radical addition upon curing and it is stated that the primary curing mechanism is by light activation. The originality of this glass-ionomer cement is the inclusion of nano-fillers which constitute up to two thirds of the filler content (circa 69 wt%).
Other advantages stated by the manufacturer are a simplified procedure which requires the priming but not the separate conditioning step and a precise dispensing and mixing “clicker” mechanism.
In spite of its uniqueness amongst other dental formulations, the nano-ionomer has not been investigated to a greater extent in the scientific dental literature. Medline search using the keyword “Ketac N100” resulted in only 4 papers in international peer-reviewed journals. Another paper was found using the keyword “nano-ionomer”. It is my pleasure to mention that the first of these 5 papers was done in Serbia by my colleagues from the Paediatric Dept of the School of Dentistry, Belgrade and the Dept. of Dentistry School of Medicine, Novi Sad.
It has been reported that fluoride concentration on material surface is similar for Ketac N100 and other glass-ionomer cements from the Fuji “family” but Ketac N100 showed less porosities and surface cracks than Fuji materials (Markovic et al 2008).
A study on bonding orthodontic brackets showed significantly lower shear bond strength for Ketac N100 compared to a conventional light-cure orthodontic bonding adhesive (Transbond XT). However, it has been suggested that this nano-ionomer may be used for bonding orthodontic brackets since the obtained shear bond strength is within clinically acceptable range (Uysal et al. 2009).
Another study using the shear bond strength as an adhesion parameter showed that Er:YAG laser dentine pre-treatment results in lower bond strength values compared to acid etching or a combined acid-etching and laser pre-treatment (Korkmaz et al. 2009).
A study on microleakage around Class V cavities showed that Er:YAG preparation results in greater microleakage than a conventional cavity preparation with a bur when a nano-ionomer (Ketac N100) and a nano-composite (Filtek Supreme XT) were used as restorative materials (Ozel et al. 2009).
In a study by Leuven BIOMAT Research Cluster it has been concluded that Ketac N100 “bonded as effectively to enamel and dentin as a conventional glass-ionomer (Fuji IX GP), but bonded less effectively than a conventional resin-modified glass-ionomer (Fuji II LC). Its bonding mechanism should be attributed to micro-mechanical interlocking provided by the surface roughness, most likely combined with chemical interaction through its acrylic/itaconic acid copolymers” (Coutinho et al. 2009).
More research is needed to investigate other mechanical properties of the nano-ionomer, its biochemical stability in the oral environment, fluoride release etc. Ultimately, well-designed randomized clinical trials will reveal the longevity and anti-cariogenic effect of this material in clinical conditions.
References:
It is stated by the manufacturer that indications for the use of this nano-ionomer include primary teeth restorations, small Class I, Class III and IV, temporary restorations, filling defects and undercuts, “sandwich” technique with resin-based composites, core build-ups with min 50% of the remaining tooth for support.
The nano-ionomer is based on the acrylic and itaconic acid copolymers necessary for the glass-ionomer reaction with fluoroaluminosilicate (FAS) glass and water. The nano-ionomer also contains a blend of resin monomers, BisGMA, TEGDMA, PEGDMA and HEMA which polymerize via the free radical addition upon curing and it is stated that the primary curing mechanism is by light activation. The originality of this glass-ionomer cement is the inclusion of nano-fillers which constitute up to two thirds of the filler content (circa 69 wt%).
Other advantages stated by the manufacturer are a simplified procedure which requires the priming but not the separate conditioning step and a precise dispensing and mixing “clicker” mechanism.
In spite of its uniqueness amongst other dental formulations, the nano-ionomer has not been investigated to a greater extent in the scientific dental literature. Medline search using the keyword “Ketac N100” resulted in only 4 papers in international peer-reviewed journals. Another paper was found using the keyword “nano-ionomer”. It is my pleasure to mention that the first of these 5 papers was done in Serbia by my colleagues from the Paediatric Dept of the School of Dentistry, Belgrade and the Dept. of Dentistry School of Medicine, Novi Sad.
It has been reported that fluoride concentration on material surface is similar for Ketac N100 and other glass-ionomer cements from the Fuji “family” but Ketac N100 showed less porosities and surface cracks than Fuji materials (Markovic et al 2008).
A study on bonding orthodontic brackets showed significantly lower shear bond strength for Ketac N100 compared to a conventional light-cure orthodontic bonding adhesive (Transbond XT). However, it has been suggested that this nano-ionomer may be used for bonding orthodontic brackets since the obtained shear bond strength is within clinically acceptable range (Uysal et al. 2009).
Another study using the shear bond strength as an adhesion parameter showed that Er:YAG laser dentine pre-treatment results in lower bond strength values compared to acid etching or a combined acid-etching and laser pre-treatment (Korkmaz et al. 2009).
A study on microleakage around Class V cavities showed that Er:YAG preparation results in greater microleakage than a conventional cavity preparation with a bur when a nano-ionomer (Ketac N100) and a nano-composite (Filtek Supreme XT) were used as restorative materials (Ozel et al. 2009).
In a study by Leuven BIOMAT Research Cluster it has been concluded that Ketac N100 “bonded as effectively to enamel and dentin as a conventional glass-ionomer (Fuji IX GP), but bonded less effectively than a conventional resin-modified glass-ionomer (Fuji II LC). Its bonding mechanism should be attributed to micro-mechanical interlocking provided by the surface roughness, most likely combined with chemical interaction through its acrylic/itaconic acid copolymers” (Coutinho et al. 2009).
More research is needed to investigate other mechanical properties of the nano-ionomer, its biochemical stability in the oral environment, fluoride release etc. Ultimately, well-designed randomized clinical trials will reveal the longevity and anti-cariogenic effect of this material in clinical conditions.
References:
- Markovic DLj, Petrovic BB, Peric TO. Fluoride content and recharge ability of five glassionomer dental materials. BMC Oral Health 2008; 28:8-21.
- Uysal T, Yagci A, Uysal B, Akdogan G. Are nano-composites and nano-ionomers suitable for orthodontic bracket bonding? Eur J Orthod 2009; Apr 28 [epub ahead of print]
- Korkmaz Y, Ozel E, Attar N, Ozge Bicer C. Influence of different conditioning methods on the shear bond strength of novel light-curing nano-ionomer restorative to enamel and dentin. Laser Med Sci 2009; Aug 18 [epub ahead of print]
- Ozel E, Korkmaz Y, Attar N, Bicer CO, Firatli E. Leakage pathway of different nano-restorative materials in class V cavities prepared by Er:YAG laser and bur preparation. Photomed Laser Surg 2009; 27:783-789
- Coutinho E, Cardoso MV, De Munck J, Neves AA, Van Landuyt KL, Poitevin A, Peumans M, Lambrechts P, Van Meerbeek B. Bonding effectiveness and interfacial characterization of a nano-filled resin-modified glass-ionomer. Dent Mater 2009; 25:1347-1357.
Sunday, 8 November 2009
Mineral trioxide aggregate (MTA) in endodontics
Mineral trioxide aggregate (MTA) is a mixture of a refined Portland cement and bismuth oxide, and also contains trace amounts of SiO2, CaO, MgO, K2SO4, and Na2SO4. MTA was first described for endodontic applications in the scientific literature in 1993. Nowadays, there are two forms of MTA on the market, the traditional gray MTA (GMTA) and white MTA (WMTA), which was introduced in 2002. WMTA has less Al2O3, MgO, and FeO and, also, smaller particles than GMTA.
MTA is prepared by mixing the powder with sterile water in a 3:1 powder/liquid ratio. This results in the formation of a colloidal gel that solidifies to a hard structure in approximately 3–4h. It is believed that moisture from the surrounding tissues favours the setting reaction.
Similar or less microleakage has been reported for MTA compared to traditional endodontic sealing materials [gutta-percha and pastes] when used as an apical restoration, furcation repair, and in the treatment of immature apices. 3mm of MTA is recommended as the minimal amount against microleakage and 5mm in the treatment of immature apices. In vitro and in vivo studies support the biocompatibility of freshly mixed and set MTA when compared to other dental materials
Clinical applications of MTA include:
pulp capping,
pulpotomy dressing,
root-end filling,
root repair [resorption and perforations] and
apexification.
Clinical prospective studies suggest that both GMTA and WMTA have similar results as traditional calcium hydroxide in non-carious mechanical pulp exposures in teeth with normal pulp tissue. However, further clinical studies are needed, particularly involving pulp exposures in carious teeth.
Clinical applications of MTA include:
pulp capping,
pulpotomy dressing,
root-end filling,
root repair [resorption and perforations] and
apexification.
Clinical prospective studies suggest that both GMTA and WMTA have similar results as traditional calcium hydroxide in non-carious mechanical pulp exposures in teeth with normal pulp tissue. However, further clinical studies are needed, particularly involving pulp exposures in carious teeth.
Clinical prospective studies using MTA as pulpotomy dressings for primary and permanent teeth reported similar or better results for MTA materials compared to formocresol or calcium hydroxide in the formation of dentine bridges and continued root development. Histological analysis has suggested a more homogenous and continuous dentine bridge formation by MTA than calcium hydroxide at both 4 and 8 weeks after treatment and less inflammation associated with MTA than calcium hydroxide.
There are several case reports in which MTA has been successfully used to repair horizontal root fractures, root resorption, internal resorption, furcation perforations and apexification and/or apexogenesis which was confirmed clinically and radiographically.
Overall results on the use of MTA in endodontics are favourable, but more well-designed and controlled clinical longitudinal studies are needed to allow systematic review and confirmation of all suggested clinical indications of MTA.
You may be interested in a list of free full text scientific articles published in international peer-reviewed journals.
Monday, 26 October 2009
Pre-fabricated, direct, single-visit, ceramic inserts
Ceramic inserts have been designed as single-visit systems and an alternative to conventional ceramic restorations produced in two appointments by means of indirect technique. Luting ceramic inserts with a small amount of composite resin is expected to reduce the amount of polymerisation shrinkage by reducing the bulk of resin composite needed to restore the tooth. Another advantage is that the occlusal contacts can be placed on the ceramic surface, rather than on the composite, for longer-term stability.
One of the most studied systems is Cerana, which utilises pre-etched and silanated leucite inlays with matched diamond burs. After caries removal and the preparation of a usual adhesive-type preparation for bonded restorations (Figure 1), the cavity is refined using one of three conical burs (Figure 2). Enamel and dentine are etched if etch-and-rinse adhesive is used or self-etch systems are applied and cured. Composite is then applied to the cavity, filling it to or just above the enamel-dentin junction (Figure 3). A thin coat of composite can be applied to the ceramic insert which is then pressed into the cavity. Excess resin composite is removed and the restoration is cured for 20 s or 40 s depending on the light-curing unit (Figure 4). The occlusal contour of the inlay is shaped to match the surrounding enamel and the occlusion adjusted (Figure 5). The restoration is cured for a further 20 s or 40s and polished.
One of the most studied systems is Cerana, which utilises pre-etched and silanated leucite inlays with matched diamond burs. After caries removal and the preparation of a usual adhesive-type preparation for bonded restorations (Figure 1), the cavity is refined using one of three conical burs (Figure 2). Enamel and dentine are etched if etch-and-rinse adhesive is used or self-etch systems are applied and cured. Composite is then applied to the cavity, filling it to or just above the enamel-dentin junction (Figure 3). A thin coat of composite can be applied to the ceramic insert which is then pressed into the cavity. Excess resin composite is removed and the restoration is cured for 20 s or 40 s depending on the light-curing unit (Figure 4). The occlusal contour of the inlay is shaped to match the surrounding enamel and the occlusion adjusted (Figure 5). The restoration is cured for a further 20 s or 40s and polished.
(Figures from manufacturer's recommendations for use. Nordiska Dental AB, Sweden)
A 3-year prospective clinical trial has shown that “The results indicate that Cerana is an alternative to composite resin restorations in Class I situations, but should be avoided in connection with Class II tunnel preparations.” (Odman 2002)
Another 8-year prospective clinical trial has shown that “Cerana is acceptable in terms of aesthetics, patient acceptance, occlusal wear and ease of use and is a good alternative for a single-visit, tooth coloured restoration in suitable cavity shapes.” (Millar & Robinson 2006)
In an in vitro study Cerana inserts luted with flowable composite in Class V cavities showed significantly less microleakage than those cemented with the high-viscous material only at the gingival margins. Microleakage was reduced around inserts compared to the bulk filling with flowable composites but no difference was observed between inserts and bulk filling with high-viscous composite material (Salim et al. 2005).
It was also shown that in vitro thermocycling 4000 times between 5 and 55 degree C does not increase microleakage around Cerana inserts (Santini et al. 2006). After thermocycling, Cerana inserts showed siginificantly less microleakage along both occlusal and gingival margins compared to Beta Quartz glass-ceramic inserts and Tetric Ceram resin-based composite. Both findings were attributed to the coefficient of thermal expansion of Cerana inserts which approximates that of enamel (Tan & Santini 2005; Santini et al. 2006).
References:
A 3-year prospective clinical trial has shown that “The results indicate that Cerana is an alternative to composite resin restorations in Class I situations, but should be avoided in connection with Class II tunnel preparations.” (Odman 2002)
Another 8-year prospective clinical trial has shown that “Cerana is acceptable in terms of aesthetics, patient acceptance, occlusal wear and ease of use and is a good alternative for a single-visit, tooth coloured restoration in suitable cavity shapes.” (Millar & Robinson 2006)
In an in vitro study Cerana inserts luted with flowable composite in Class V cavities showed significantly less microleakage than those cemented with the high-viscous material only at the gingival margins. Microleakage was reduced around inserts compared to the bulk filling with flowable composites but no difference was observed between inserts and bulk filling with high-viscous composite material (Salim et al. 2005).
It was also shown that in vitro thermocycling 4000 times between 5 and 55 degree C does not increase microleakage around Cerana inserts (Santini et al. 2006). After thermocycling, Cerana inserts showed siginificantly less microleakage along both occlusal and gingival margins compared to Beta Quartz glass-ceramic inserts and Tetric Ceram resin-based composite. Both findings were attributed to the coefficient of thermal expansion of Cerana inserts which approximates that of enamel (Tan & Santini 2005; Santini et al. 2006).
References:
- Odman P. A 3-year clinical evaluation of Cerana prefabricated ceramic inlays. Int J Prosthodont 2002; 15: 79-82.
- Millar BJ, Robinson PB. Eight year results with direct ceramic restorations (Cerana). Br Dent J 2006; 201:515-520.
- Salim S, Santini A, Safar KN. Microleakage around glass-ceramic insert restorations luted with a high-viscous or flowable composite. J Esthet Restor Dent 2005;17: 30-38.
- Santini A, Ivanovic V, Tan CL, Ibbetson R. Effect of prolonged thermal cycling on microleakage around Class V cavities restored with glass-ceramic inserts with different coefficients of thermal expansion: an in vitro study. Prim Dent Care. 2006 Oct;13(4):147-53.
- Tan CL, Santini A. Marginal microleakage around class V cavities restored with glass ceramic inserts of different coefficients of thermal expansion. J Clin Dent. 2005;16(1):26-31.
Monday, 12 October 2009
Resin-based materials: Degree of conversion
Resin-based materials, such as resin-based composites, adhesives, pit & fissure sealants and resin cements, undergo monomer to polymer conversion during both light-activated or chemically-activated polymerisation. Whilst conversion is an inherent property of resin-based materials, the degree of conversion (DC) depends on material chemical composition and curing conditions. The DC affects mechanical properties of resin-based materials, such as wear, fracture toughness, hardness, flexural modulus and fatigue. Less than optimal conversion may compromise mechanical properties but also result in leaching of monomers from restorations.
Traditionally, manufacturers' technical and scientific data did not incorporate results of internal or external tests for the DC. Even most recent materials often lack these data but there seems to be a growing understanding of the importance of this property.
The DC of resin-based materials in dental studies has been determined using various methods for more than two decades, but recently, the most widely accepted and used methods are infrared and Raman spectroscopy. These are based on measuring the changes in either the absorbance or scattering effect of those molecular groups which take part in polymerisation of resin-based materials. The DC is determined as the ratio of absorbance or scattering of these groups and a certain internal standard in uncured and cured material. An internal standard is another molecular group which does not take part in polymerisation and, thus, its infrared absorbance or Raman scattering remains constant before and after polymerisation.
It is very important to point out that the DC indicates the number of unreacted methacrylate or other polymerisable groups and not the amount of unreacted monomers in the polymer. The DC of e.g. 70% indicates that there is 30% of uncreacted groups and not 30% of free, unreacted monomers trapped within the polymer network that could theoretically leach out. Cross-linking monomers in resin-based materials most often contain more than one polymerisable group which means that cross-linking may occur via some but not all such groups. Furthermore, unreacted polymerisable groups always exist at the ends of polymer chains. There have been some estimates that in resin-based composites with the DC of around 70%, the amount of unreacted monomers is actually less than 10%. This depends on material chemical composition and may vary significantly in different resin-based materials.
Traditionally, manufacturers' technical and scientific data did not incorporate results of internal or external tests for the DC. Even most recent materials often lack these data but there seems to be a growing understanding of the importance of this property.
The DC of resin-based materials in dental studies has been determined using various methods for more than two decades, but recently, the most widely accepted and used methods are infrared and Raman spectroscopy. These are based on measuring the changes in either the absorbance or scattering effect of those molecular groups which take part in polymerisation of resin-based materials. The DC is determined as the ratio of absorbance or scattering of these groups and a certain internal standard in uncured and cured material. An internal standard is another molecular group which does not take part in polymerisation and, thus, its infrared absorbance or Raman scattering remains constant before and after polymerisation.
It is very important to point out that the DC indicates the number of unreacted methacrylate or other polymerisable groups and not the amount of unreacted monomers in the polymer. The DC of e.g. 70% indicates that there is 30% of uncreacted groups and not 30% of free, unreacted monomers trapped within the polymer network that could theoretically leach out. Cross-linking monomers in resin-based materials most often contain more than one polymerisable group which means that cross-linking may occur via some but not all such groups. Furthermore, unreacted polymerisable groups always exist at the ends of polymer chains. There have been some estimates that in resin-based composites with the DC of around 70%, the amount of unreacted monomers is actually less than 10%. This depends on material chemical composition and may vary significantly in different resin-based materials.
Friday, 2 October 2009
Filtek Silorane by 3M ESPE
In 2007, 3M ESPE launched a new resin-based composite, Filtek Silorane (FS), and its adhesive system. Both the composite and the adhesive system contain a unique resin monomer based on the combination of siloxanes and oxiranes so it is apparent where the term "silorane" comes from. The polymerisation of FS differs from methacrylate-based composites and adhesives and is claimed to result in reduced polymerisation shrinkage. The cationic polymerisation of FS occurs via the ring opening of the C-O-C epoxide group which ends up in less reduction in molecule distances compared to the free radical polymerisation of methacrylate-based composites. In the latter, monomer interaction via methacrylate C=C groups results in the greater reduction of inter-molecular distances and subsequently greater polymerisation shrinkage.
Most recent studies have shown reduced shrinkage and shrinkage stress and strain for FS compared to methacrylate-based composites. Microleakage and nanoleakage were also reported for FS. Ongoing studies will reveal other properties of FS that may affect its clinical performance.
The dedicated adhesive system is designed to bridge the gap between hydrophilic dentine and hydrophobic FS composite. It contains the Primer and the Bond in separate bottles which are cured as separate layers, unlike any other two-step self-etch adhesive system, where primer and bond are mixed before curing. In Filtek Silorane adhesive system, these layers are not visible on SEM but can be detected using micro-Raman spectroscopy (Santini & Miletic, 2008) At the BSDR symposium on Dental materials it was reported, that after 6 months of storage, the type of failure for FS changes from the adhesive to cohesive as the fracture occurs within the adhesive system. The intermediate zone between FS Primer and Bond of about 1 micron may be the weak link in the failure mechanism and certainly needs further investigation.
Thursday, 24 September 2009
Research methodology: The effect of "material A" on treatment outcome
I've recently discussed with a colleague the possibility to prove or disprove the efficacy of a certain clinical procedure on treatment outcome. Since this is the dental materials blog, I'm going to make the parallel between clinical procedures and dental materials and discuss this matter as if it was about dental materials. From the research methodology point of view, it makes no difference whether it is a dental material or a clinical procedure.
"Randomized control clinical trial" would probably be the most appropriate study design to evaluate whether a certain material (material A) has any effect whatsoever on the outcome of a particular treatment. In a recently published book "Introduction to randomized control clinical trials" by JNS Matthews, there is a very nice definition:
"A randomized concurrently controlled clinical trial is simply an experiment performed on human subjects to assess the efficacy of a new treatment for some condition. It has two key features:
"Trials are applied to many different modes of treatment... for example, new surgical procedures, screening programs, diagnostic procedures etc."(1)
How does this apply to our material A? A double-blind trial would be impossible in this case, because a clinician would always know the details of the treatment. On the other hand, a single-blind trial would be possible and recommended since the patient wouldn't know the details of the treatment in order to exclude the possible placebo effect.
Patient inclusion criteria should be taken into consideration at the beginning of the trial. These include, but are not restricted to, patient age, general health, the diagnosis of the current dental condition, the history of this condition etc. It would be wise to "standardise" the cohort so that the number of variables is reduced as much as possible. For example, root canal treatment of a pulpitis may have a different outcome than the treatment of periapical disease, because of the nature of the two dental conditions and variations in patients' immunological response to any of them. Therefore, it would be recommended that one of the inclusion criteria is the uniformity of clinical diagnosis.
Randomization would be easy using the table of random numbers. It excludes any potential bias and is always preferred to other ways of patient selection, as long as the number of cases in both the treated and control group is the same or as similarly-sized as possible. Most statistical tests are most powerful when the groups being compared have equal sizes.
Then, once the treatment is performed, the treated group would receive material A and the control group would receive placebo. The outcome of the treatment would be monitored over at least 3 years, using the standard parameters for monitoring the outcome of this particular treatment. After the monitoring period, (an) appropriate statistical test(s) would be used to assess the difference in treatment outcomes between the two groups of patients.
Only then would it be possible to claim that material A has any effect on the outcome of this particular dental treatment.
(1) Matthews JNS. Introduction to randomized control clinical trials. 2nd edition. Chapman&Hall/CRC; Boca Raton, FL, USA; 2006.
"Randomized control clinical trial" would probably be the most appropriate study design to evaluate whether a certain material (material A) has any effect whatsoever on the outcome of a particular treatment. In a recently published book "Introduction to randomized control clinical trials" by JNS Matthews, there is a very nice definition:
"A randomized concurrently controlled clinical trial is simply an experiment performed on human subjects to assess the efficacy of a new treatment for some condition. It has two key features:
- The new treatment is given to a group of patients (treated group) and another treatment, often the most widely used, is given to another group of patients at the same time (control group). This is what makes the trial concurrently controlled.
- Patients are allocated to one group or another by randomization. "(1)
"Trials are applied to many different modes of treatment... for example, new surgical procedures, screening programs, diagnostic procedures etc."(1)
How does this apply to our material A? A double-blind trial would be impossible in this case, because a clinician would always know the details of the treatment. On the other hand, a single-blind trial would be possible and recommended since the patient wouldn't know the details of the treatment in order to exclude the possible placebo effect.
Patient inclusion criteria should be taken into consideration at the beginning of the trial. These include, but are not restricted to, patient age, general health, the diagnosis of the current dental condition, the history of this condition etc. It would be wise to "standardise" the cohort so that the number of variables is reduced as much as possible. For example, root canal treatment of a pulpitis may have a different outcome than the treatment of periapical disease, because of the nature of the two dental conditions and variations in patients' immunological response to any of them. Therefore, it would be recommended that one of the inclusion criteria is the uniformity of clinical diagnosis.
Randomization would be easy using the table of random numbers. It excludes any potential bias and is always preferred to other ways of patient selection, as long as the number of cases in both the treated and control group is the same or as similarly-sized as possible. Most statistical tests are most powerful when the groups being compared have equal sizes.
Then, once the treatment is performed, the treated group would receive material A and the control group would receive placebo. The outcome of the treatment would be monitored over at least 3 years, using the standard parameters for monitoring the outcome of this particular treatment. After the monitoring period, (an) appropriate statistical test(s) would be used to assess the difference in treatment outcomes between the two groups of patients.
Only then would it be possible to claim that material A has any effect on the outcome of this particular dental treatment.
(1) Matthews JNS. Introduction to randomized control clinical trials. 2nd edition. Chapman&Hall/CRC; Boca Raton, FL, USA; 2006.
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