Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06608563
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-19
Brief Title:
The Effect of an Adhesive System on the Retention and Caries Prevention for Fissure Sealants in Permanent Molars
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Effect of an Adhesive System on the Retention and Caries Prevention for Fissure Sealants in Permanent Molars a 2-year Randomised Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ResinFS
Brief Summary:
Background Resin-based fissure sealants FS are recommended to prevent pit-and-fissure caries development or prevent the progression of enamel caries lesion to frank cavitation into dentine There is still limited clinical evidence on the use of adhesive system beneath fissure sealants in permanent molars and its effect on FS retention and caries progression
Aim The aim of this randomised clinical trial is to evaluate the clinical efficacy of fissure sealants placed with and without prior use of an adhesive system in terms of retention and caries prevention in permanent molars over the period of 2 years
Study design Children 6-12 years of age with high caries risk that require sealants in their first permanent molars ICDAS 0-3 will be selected at the Dublin Dental University Hospital DDUH Molars will be stratified according to presence of caries lesions ICDAS 0 or ICDAS1-3 and randomly allocated according to the study groups Test group 17 phosphoric acid adhesive system FS Control group 17 phosphoric acid FS The randomisation unit will be the tooth and more than one tooth can be included per child sample size308 teeth All children will be evaluated after 12 and 24 months by calibrated independent examiners The primary outcome of the present trial is caries prevention dentine caries free surfaces after 2 years of follow-up The secondary outcome is sealant retention over time Clinical variables such as age gender tooth position upperlower caries experience DMFTdmft stage of eruption eruptedpartially erupted and childrens behavior Frankl scale will be collected The proportion caries free surfaces at 24 months will be evaluated using Logistic Regression analysis Sealant retention over time will be compared using log-rank test and Kaplan Meier survival analysis Cox regression analysis with shared frailty will be used to evaluate association with independent variables α5
Aim The aim of this randomised clinical trial is to evaluate the clinical efficacy of fissure sealants placed with and without prior use of an adhesive system in terms of retention and caries prevention in permanent molars over the period of 2 years
Study design Children 6-12 years of age with high caries risk that require sealants in their first permanent molars ICDAS 0-3 will be selected at the Dublin Dental University Hospital DDUH Molars will be stratified according to presence of caries lesions ICDAS 0 or ICDAS1-3 and randomly allocated according to the study groups Test group 17 phosphoric acid adhesive system FS Control group 17 phosphoric acid FS The randomisation unit will be the tooth and more than one tooth can be included per child sample size308 teeth All children will be evaluated after 12 and 24 months by calibrated independent examiners The primary outcome of the present trial is caries prevention dentine caries free surfaces after 2 years of follow-up The secondary outcome is sealant retention over time Clinical variables such as age gender tooth position upperlower caries experience DMFTdmft stage of eruption eruptedpartially erupted and childrens behavior Frankl scale will be collected The proportion caries free surfaces at 24 months will be evaluated using Logistic Regression analysis Sealant retention over time will be compared using log-rank test and Kaplan Meier survival analysis Cox regression analysis with shared frailty will be used to evaluate association with independent variables α5
Detailed Description:
Introduction
Resin-based fissure sealants FS have been used as a physical barrier in pit-and-fissures with the aim to reduce biofilm accumulation and prevent the development of new caries lesions in first permanent molars Several international guidelines recommend the use of FS for caries prevention in the paediatric population
The majority of the FS manufactures recommend the etching of the enamel surface prior to FS application in order to remove any remaining plaque debris and to increase the surface contact area by superficial demineralisation of tooth surface Resin based-fissure sealants contain light-activated urethane dimethacrylate UDMA or bisphenol A-glycidyl methacrylate Bis-GMA resin in its composition which bonds to the etched enamel Several clinical studies have investigated the use of an intermediate layer of adhesive system primer and bond in order to increase the bonding strength and increase retention of FS over time in caries free molars however little is known on the effect on caries progression and the choice of FS protocol for treatment of enamel caries lesions
Another factor that can influence the performance of resin-based fissure sealant due to hydrophobic characteristics of the material is the presence of saliva contamination poor moisture control during application Therefore the stage of eruption patients behaviour and operator experience can play a major role when it comes to FS retention on tooth surfaces The majority of clinical trials in the field had trained and experienced operators including specialists in paediatric dentistry which could impact the translational and external validity of their findings More studies are needed with less experienced operators in order to evaluate the effectiveness of FS placement in different environments
Therefore the aim of the present randomised clinical trial is to evaluate the effectiveness of resin-based fissure sealant placed by undergraduate dental students with or without an intermediate layer of adhesive system in terms of dentine caries prevention and retention over time
Methods
Study Design The present study is a two-parallel arm controlled single-blind clinical trial This study will be registered at Clinical Trials website and submitted to approval by the local Ethics Committee SJHAMNCH Joint Research Ethics Committee
Sample Size Calculation For the sample size calculation we have considered the primary outcome as caries increment as reported by Ulusu et al 201212 The caries increment reported was 48 after 24 months for resin-based fissure sealants placed by undergraduate dental students The sample size calculation was performed using Stata 170 software StataCorp Texas USA considering two proportions in a cluster randomised design A difference between the groups of 5 was used for a two-tailed test Stata output can be found below A minimum of 280 teeth per group is required when considering that more than one tooth can be included per child mean cluster size2 Considering a possible loss to follow-up of 10 a minimum sample size of 308 teeth will be required
Introduction
Resin-based fissure sealants FS have been used as a physical barrier in pit-and-fissures with the aim to reduce biofilm accumulation and prevent the development of new caries lesions in first permanent molars Several international guidelines recommend the use of FS for caries prevention in the paediatric population
The majority of the FS manufactures recommend the etching of the enamel surface prior to FS application in order to remove any remaining plaque debris and to increase the surface contact area by superficial demineralisation of tooth surface Resin based-fissure sealants contain light-activated urethane dimethacrylate UDMA or bisphenol A-glycidyl methacrylate Bis-GMA resin in its composition which bonds to the etched enamel Several clinical studies have investigated the use of an intermediate layer of adhesive system primer and bond in order to increase the bonding strength and increase retention of FS over time in caries free molars6-9 however few is known on the effect on caries progression and the choice of FS protocol for treatment of enamel caries lesions
Another factor that can influence the performance of resin-based fissure sealant due to hydrophobic characteristics of the material is the presence of saliva contamination poor moisture control during application Therefore the stage of eruption patients behaviour and operator experience can play a major role when it comes to FS retention to tooth surface The majority of clinical trials in the field had trained and experienced operators including specialists in paediatric dentistry which could impact the translational and external validity of their findings More studies are needed with less experienced operators in order to evaluate the effectiveness of FS placement in less controlled environments
Therefore the aim of the present randomised clinical trial is to evaluate the effectiveness of resin-based fissure sealant placed by undergraduate dental students with or without an intermediate layer of adhesive system in terms of dentine caries prevention and retention over time
Methods
Study Design The present study is a two-parallel arm controlled single-blind clinical trial This study will be registered at Clinical Trials website and submitted to approval by the local Ethics Committee SJHAMNCH Joint Research Ethics Committee
Sample Size Calculation For the sample size calculation we have considered the primary outcome as caries increment as reported by Ulusu et al 201212 The caries increment reported was 48 after 24 months for resin-based fissure sealants placed by undergraduate dental students The sample size calculation was performed using Stata 170 software StataCorp Texas USA considering two proportions in a cluster randomised design A difference between the groups of 5 was used for a two-tailed test Stata output can be found below A minimum of 280 teeth per group is required when considering that more than one tooth can be included per child mean cluster size2 Considering a possible loss to follow-up of 10 a minimum sample size of 308 teeth will be required
Inclusion and exclusion criteria specified in elegibility section
Randomisation process The randomisation unit is the tooth and more than one tooth can be included per child The website httpswwwsealedenvelopecomsimple-randomiserv1lists will be used for randomisation list generation using blocks of different sizes 4 6 and 8 Sealed sequentially numbered opaque envelopes will be used and opened at the time of sealant placement
Operators All sealants will be placed by undergraduate dental students during the undergraduate clinic in Paediatric Dentistry The treatment will be supervised by an experienced dentistclinical supervisor
Interventions
Control group FS
1 Cotton roll isolation cotton roll will be placed buccally and linguallypalatally to the first permanent molar to be treated A saliva ejector will be used to remove any excess of saliva If the cotton roll are saturared in saliva at any point of the treatment they will need to be changed
2 Etching of the enamel surface 17 phosphoric acid will be applied for 15 seconds over the surface to be sealed Phosphoric etchant gel - Vococid VOCO using the etch syringe applicator tip
3 Washingdrying a 3-1 syringe will be used to rinse all etch material from the toothsurface A high volume suction will be used Cotton pellets will be changed to a dry ones at this stage and the surface will be dried for 5s using the air syringe
4 Sealant application a light-curing nano-hybrid fissure sealant material Grandio Seal VOCO will be applied using the applicator tip A probe will be used to ensure that the material is present in all fissures without any air bubbles
5 Lightcuring The material will be lightcured for 20 seconds The material colour will change to an opaque off white colour when exposed to light
6 Check occlusion After checking for premature contact points if there is a need to remove a excess of material a superfine diamond bur or a silicone finishing point can be used for adjustments
Test group Adhesive FS
1 Cotton roll isolation cotton roll will be placed buccally and linguallypalatally to the first permanent molar to be treated A saliva ejector will be used to remove any excess of saliva If the cotton roll are saturared in saliva at any point of the treatment they will need to be changed
2 Etching of the enamel surface 17 phosphoric acid will be applied for 15 seconds over the surface to be sealed Phosphoric etchant gel - Vococid VOCO using the etch syringe applicator tip
3 Washingdrying a 3-1 syringe will be used to rinse all etch material from the toothsurface A high volume suction will be used Cotton pellets will be changed to a dry ones at this stage and the surface will be dried for 5s using the air syringe
4 Adhesive system application the adhesive system Futurabond VOCO single dose capsule will be applied over the surface to be sealed for 5 seconds using a microbrush ative movements along the fissures to ensure bond penetration The bond will be air thin dried for removal of solvent and excess material The bond will be lightcured for 10s before sealant placement
5 Sealant application a light-curing nano-hybrid fissure sealant material Grandio Seal VOCO will be applied using the applicator tip A probe will be used to ensure that the material is present in all fissures without any air bubbles
6 Lightcuring The material will be lightcured for 20 seconds The material colour will change to an opaque off white colour when exposed to light
7 Check occlusion After checking for premature contact points if there is a need to remove a excess of material a superfine diamond bur or a silicone finishing point can be used for adjustments
Clinical variables such as childrens age and gender tooth position upperlower caries experience DMFTdmft ICDAS score tooth surface 123 and childrens behavior during the procedure Frankl scale will be collected
Evaluations
All children will be evaluated after 12 and 24 months by independent calibrated and blind examiners for both primary caries lesion progression and secondary outcomes sealant retention
The presence of dental caries lesion will evaluated according to ICDAS criteria and caries progression into dentine will be recorded Sealant retention will be evaluated according to the scoring system proposed by Oba et al 2009 0 fully retained sealant 1 partially retained sealant or 2 absent sealant
Statistical Analysis
The proportion caries free surfaces at 24 months will be evaluated using Logistic Regression analysis Sealant retention over time will be compared using log-rank test and Kaplan Meier survival analysis Cox regression analysis with shared frailty will be used to evaluate association with independent variables α5
Resin-based fissure sealants FS have been used as a physical barrier in pit-and-fissures with the aim to reduce biofilm accumulation and prevent the development of new caries lesions in first permanent molars Several international guidelines recommend the use of FS for caries prevention in the paediatric population
The majority of the FS manufactures recommend the etching of the enamel surface prior to FS application in order to remove any remaining plaque debris and to increase the surface contact area by superficial demineralisation of tooth surface Resin based-fissure sealants contain light-activated urethane dimethacrylate UDMA or bisphenol A-glycidyl methacrylate Bis-GMA resin in its composition which bonds to the etched enamel Several clinical studies have investigated the use of an intermediate layer of adhesive system primer and bond in order to increase the bonding strength and increase retention of FS over time in caries free molars however little is known on the effect on caries progression and the choice of FS protocol for treatment of enamel caries lesions
Another factor that can influence the performance of resin-based fissure sealant due to hydrophobic characteristics of the material is the presence of saliva contamination poor moisture control during application Therefore the stage of eruption patients behaviour and operator experience can play a major role when it comes to FS retention on tooth surfaces The majority of clinical trials in the field had trained and experienced operators including specialists in paediatric dentistry which could impact the translational and external validity of their findings More studies are needed with less experienced operators in order to evaluate the effectiveness of FS placement in different environments
Therefore the aim of the present randomised clinical trial is to evaluate the effectiveness of resin-based fissure sealant placed by undergraduate dental students with or without an intermediate layer of adhesive system in terms of dentine caries prevention and retention over time
Methods
Study Design The present study is a two-parallel arm controlled single-blind clinical trial This study will be registered at Clinical Trials website and submitted to approval by the local Ethics Committee SJHAMNCH Joint Research Ethics Committee
Sample Size Calculation For the sample size calculation we have considered the primary outcome as caries increment as reported by Ulusu et al 201212 The caries increment reported was 48 after 24 months for resin-based fissure sealants placed by undergraduate dental students The sample size calculation was performed using Stata 170 software StataCorp Texas USA considering two proportions in a cluster randomised design A difference between the groups of 5 was used for a two-tailed test Stata output can be found below A minimum of 280 teeth per group is required when considering that more than one tooth can be included per child mean cluster size2 Considering a possible loss to follow-up of 10 a minimum sample size of 308 teeth will be required
Introduction
Resin-based fissure sealants FS have been used as a physical barrier in pit-and-fissures with the aim to reduce biofilm accumulation and prevent the development of new caries lesions in first permanent molars Several international guidelines recommend the use of FS for caries prevention in the paediatric population
The majority of the FS manufactures recommend the etching of the enamel surface prior to FS application in order to remove any remaining plaque debris and to increase the surface contact area by superficial demineralisation of tooth surface Resin based-fissure sealants contain light-activated urethane dimethacrylate UDMA or bisphenol A-glycidyl methacrylate Bis-GMA resin in its composition which bonds to the etched enamel Several clinical studies have investigated the use of an intermediate layer of adhesive system primer and bond in order to increase the bonding strength and increase retention of FS over time in caries free molars6-9 however few is known on the effect on caries progression and the choice of FS protocol for treatment of enamel caries lesions
Another factor that can influence the performance of resin-based fissure sealant due to hydrophobic characteristics of the material is the presence of saliva contamination poor moisture control during application Therefore the stage of eruption patients behaviour and operator experience can play a major role when it comes to FS retention to tooth surface The majority of clinical trials in the field had trained and experienced operators including specialists in paediatric dentistry which could impact the translational and external validity of their findings More studies are needed with less experienced operators in order to evaluate the effectiveness of FS placement in less controlled environments
Therefore the aim of the present randomised clinical trial is to evaluate the effectiveness of resin-based fissure sealant placed by undergraduate dental students with or without an intermediate layer of adhesive system in terms of dentine caries prevention and retention over time
Methods
Study Design The present study is a two-parallel arm controlled single-blind clinical trial This study will be registered at Clinical Trials website and submitted to approval by the local Ethics Committee SJHAMNCH Joint Research Ethics Committee
Sample Size Calculation For the sample size calculation we have considered the primary outcome as caries increment as reported by Ulusu et al 201212 The caries increment reported was 48 after 24 months for resin-based fissure sealants placed by undergraduate dental students The sample size calculation was performed using Stata 170 software StataCorp Texas USA considering two proportions in a cluster randomised design A difference between the groups of 5 was used for a two-tailed test Stata output can be found below A minimum of 280 teeth per group is required when considering that more than one tooth can be included per child mean cluster size2 Considering a possible loss to follow-up of 10 a minimum sample size of 308 teeth will be required
Inclusion and exclusion criteria specified in elegibility section
Randomisation process The randomisation unit is the tooth and more than one tooth can be included per child The website httpswwwsealedenvelopecomsimple-randomiserv1lists will be used for randomisation list generation using blocks of different sizes 4 6 and 8 Sealed sequentially numbered opaque envelopes will be used and opened at the time of sealant placement
Operators All sealants will be placed by undergraduate dental students during the undergraduate clinic in Paediatric Dentistry The treatment will be supervised by an experienced dentistclinical supervisor
Interventions
Control group FS
1 Cotton roll isolation cotton roll will be placed buccally and linguallypalatally to the first permanent molar to be treated A saliva ejector will be used to remove any excess of saliva If the cotton roll are saturared in saliva at any point of the treatment they will need to be changed
2 Etching of the enamel surface 17 phosphoric acid will be applied for 15 seconds over the surface to be sealed Phosphoric etchant gel - Vococid VOCO using the etch syringe applicator tip
3 Washingdrying a 3-1 syringe will be used to rinse all etch material from the toothsurface A high volume suction will be used Cotton pellets will be changed to a dry ones at this stage and the surface will be dried for 5s using the air syringe
4 Sealant application a light-curing nano-hybrid fissure sealant material Grandio Seal VOCO will be applied using the applicator tip A probe will be used to ensure that the material is present in all fissures without any air bubbles
5 Lightcuring The material will be lightcured for 20 seconds The material colour will change to an opaque off white colour when exposed to light
6 Check occlusion After checking for premature contact points if there is a need to remove a excess of material a superfine diamond bur or a silicone finishing point can be used for adjustments
Test group Adhesive FS
1 Cotton roll isolation cotton roll will be placed buccally and linguallypalatally to the first permanent molar to be treated A saliva ejector will be used to remove any excess of saliva If the cotton roll are saturared in saliva at any point of the treatment they will need to be changed
2 Etching of the enamel surface 17 phosphoric acid will be applied for 15 seconds over the surface to be sealed Phosphoric etchant gel - Vococid VOCO using the etch syringe applicator tip
3 Washingdrying a 3-1 syringe will be used to rinse all etch material from the toothsurface A high volume suction will be used Cotton pellets will be changed to a dry ones at this stage and the surface will be dried for 5s using the air syringe
4 Adhesive system application the adhesive system Futurabond VOCO single dose capsule will be applied over the surface to be sealed for 5 seconds using a microbrush ative movements along the fissures to ensure bond penetration The bond will be air thin dried for removal of solvent and excess material The bond will be lightcured for 10s before sealant placement
5 Sealant application a light-curing nano-hybrid fissure sealant material Grandio Seal VOCO will be applied using the applicator tip A probe will be used to ensure that the material is present in all fissures without any air bubbles
6 Lightcuring The material will be lightcured for 20 seconds The material colour will change to an opaque off white colour when exposed to light
7 Check occlusion After checking for premature contact points if there is a need to remove a excess of material a superfine diamond bur or a silicone finishing point can be used for adjustments
Clinical variables such as childrens age and gender tooth position upperlower caries experience DMFTdmft ICDAS score tooth surface 123 and childrens behavior during the procedure Frankl scale will be collected
Evaluations
All children will be evaluated after 12 and 24 months by independent calibrated and blind examiners for both primary caries lesion progression and secondary outcomes sealant retention
The presence of dental caries lesion will evaluated according to ICDAS criteria and caries progression into dentine will be recorded Sealant retention will be evaluated according to the scoring system proposed by Oba et al 2009 0 fully retained sealant 1 partially retained sealant or 2 absent sealant
Statistical Analysis
The proportion caries free surfaces at 24 months will be evaluated using Logistic Regression analysis Sealant retention over time will be compared using log-rank test and Kaplan Meier survival analysis Cox regression analysis with shared frailty will be used to evaluate association with independent variables α5
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None