Ignite Creation Date:
2024-05-06 @ 7:25 PM
Last Modification Date:
2024-10-26 @ 3:06 PM
Study NCT ID:
NCT06003452
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-08-23
First Post:
2023-08-15
Brief Title:
Retention Rate And Caries Prevention Of Giomer Based Sealant With And Without Pre-Treatment With Bioactive Glass Air Abrasion In Young Adults
Sponsor:
Cairo University
Organization:
Cairo University
Study Overview
Official Title:
Retention Rate And Caries Prevention Of Giomer Based Sealant With And Without Pre-Treatment With Bioactive Glass Air Abrasion In Young Adults
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Prevention of oral diseases is preferable to treatment and is the key method of achieving cost effectiveness for oral health improvement programs Various preventive strategies for dental caries have been tried and are still being developed The occlusal pits and fissures of posterior teeth are highly susceptible to caries because of the anatomy of pit and fissure surfaces which favours stagnation of bacteria and substrates Fissure sealing has been shown to be an evidence-based caries preventive method for protecting the occlusal surfaces against caries Non- sealed teeth need to be restored approximately 50 more frequently compared to their sealed counterpart Sealants are effective caries preventive agents as long as they remain bonded to teeth
It has been proposed that sealants should be placed on both sound teeth and incipient non-cavitated carious lesions on permanent teeth of high caries risk patients in order to prevent the onset of caries and its progression According to the American Dental Association Guidelines for the use of pit and fissure sealants ICDAS II codes 0 1 and 2 are recommended for sealant applicationA variety of dental materials have been used as sealants using different application techniques Their effectiveness depends on the formation of a complete seal and is increased by correct technique and moisture control appropriate follow-up and resealing as necessary Resin-based conventional sealants are preferred choice however use of phosphoric acid demineralizes the enamel layer and have elongated treatment time and is more technique sensitive
It has been proposed that sealants should be placed on both sound teeth and incipient non-cavitated carious lesions on permanent teeth of high caries risk patients in order to prevent the onset of caries and its progression According to the American Dental Association Guidelines for the use of pit and fissure sealants ICDAS II codes 0 1 and 2 are recommended for sealant applicationA variety of dental materials have been used as sealants using different application techniques Their effectiveness depends on the formation of a complete seal and is increased by correct technique and moisture control appropriate follow-up and resealing as necessary Resin-based conventional sealants are preferred choice however use of phosphoric acid demineralizes the enamel layer and have elongated treatment time and is more technique sensitive
Detailed Description:
It has been proposed that sealants should be placed on both sound teeth and incipient non-cavitated carious lesions on permanent teeth of high caries risk patients in order to prevent the onset of caries and its progression According to the American Dental Association Guidelines for the use of pit and fissure sealants ICDAS II codes 0 1 and 2 are recommended for sealant application A variety of dental materials have been used as sealants using different application techniques Their effectiveness depends on the formation of a complete seal and is increased by correct technique and moisture control appropriate follow-up and resealing as necessary Resin-based conventional sealants are preferred choice however use of phosphoric acid demineralizes the enamel layer and have elongated treatment time and is more technique sensitive3
A new bioactive hybrid material giomer that combined the advantages of resin composites with glass ionomer cements has been introduced it based on pre-reacted glass ionomer PRG filler technology in which fluoroaluminosilicate glass particles that have previously reacted with the polyacrylic acid were dispersed in resin Giomer based pit and fissure sealant using self-etch primer eliminates phosphoric acid etch and rinse thus conserving the enamel and reducing chair side time However retention of self-etch adhesive as compared to conventional sealants is questionable4
A new method for sealant application using air- abrasive technology is less technique sensitive and allows for further cleaning of the grooves prior to sealant placement The abrasive particles used in air abrasion effectively remove organic plug material from the grooves and allow for deeper penetration of the sealant material into the grooves5
Aim of the study
The aim of study is to evaluate retention rate and caries prevention of giomer based sealant with and without pre-treatment by bioactive glass air abrasion in young adults over one year
PICOTS
P PatientPopulation Deep retentive fissures ICDAS 012 in second and third molars for 17-22 years old patients
I Intervention Giomer Based Sealant With Prior BioactiveGlass Air Abrasion C Comparator Giomer Based Sealant Without Prior Bioactive Glass Air Abrasion
O Outcome
Prioritization of Outcome
Outcome Method of Measurement with reference
Unit of Measurement
1 ry Outcome Loss of retention Simonsens criteria
Full retention FR The material was fully present on the occlusal surfaces
Partially lost PL The material was present but as a result of either wear or loss of the material part of a previously sealed pit or fissure or both was exposed
Totally lost TL No trace of the material was detected on the surface
2 ry Outcomes Secondary Caries Modified USPHS criteria7 Alpha Absence of the caries Charlie Presence of the caries
T Time - T0 - Baseline T1- 3 months Study Design Two parallel arms randomized clinical trial Study Framework Superiority framework
Hypothesis
The null hypothesis tested in this study is that there will be no difference either in the retention rate or caries prevention of giomer based sealant with and without treatment by bioactive glass air abrasion in young adults
Research question
In deep retentive fissures Will the use of bioactive glass air abrasion particles improve the retention rate and caries prevention of the giomer based sealant
Methodology
In Group 1 the self-etch primer BeautiSealant Primer Shofu Japan will be applied to the occlusal fissures with a fine micro brush After waiting for 5 s gently air blow for about 3 sec and then dry with stronger stream of air until a thin and uniform bonding layer is obtained The giomer sealant In Group 2 occlusal surface will be subjected to 5s of bioglass AquaCare- Velopex International then sealant BeautiSealant Paste Shofu Japan will be applied as aforementioned steps and light-cured for 20 s In both groups the surfaces were checked with an explorer to ensure that no voids were present The occlusion was checked and if necessary adjusted
A new bioactive hybrid material giomer that combined the advantages of resin composites with glass ionomer cements has been introduced it based on pre-reacted glass ionomer PRG filler technology in which fluoroaluminosilicate glass particles that have previously reacted with the polyacrylic acid were dispersed in resin Giomer based pit and fissure sealant using self-etch primer eliminates phosphoric acid etch and rinse thus conserving the enamel and reducing chair side time However retention of self-etch adhesive as compared to conventional sealants is questionable4
A new method for sealant application using air- abrasive technology is less technique sensitive and allows for further cleaning of the grooves prior to sealant placement The abrasive particles used in air abrasion effectively remove organic plug material from the grooves and allow for deeper penetration of the sealant material into the grooves5
Aim of the study
The aim of study is to evaluate retention rate and caries prevention of giomer based sealant with and without pre-treatment by bioactive glass air abrasion in young adults over one year
PICOTS
P PatientPopulation Deep retentive fissures ICDAS 012 in second and third molars for 17-22 years old patients
I Intervention Giomer Based Sealant With Prior BioactiveGlass Air Abrasion C Comparator Giomer Based Sealant Without Prior Bioactive Glass Air Abrasion
O Outcome
Prioritization of Outcome
Outcome Method of Measurement with reference
Unit of Measurement
1 ry Outcome Loss of retention Simonsens criteria
Full retention FR The material was fully present on the occlusal surfaces
Partially lost PL The material was present but as a result of either wear or loss of the material part of a previously sealed pit or fissure or both was exposed
Totally lost TL No trace of the material was detected on the surface
2 ry Outcomes Secondary Caries Modified USPHS criteria7 Alpha Absence of the caries Charlie Presence of the caries
T Time - T0 - Baseline T1- 3 months Study Design Two parallel arms randomized clinical trial Study Framework Superiority framework
Hypothesis
The null hypothesis tested in this study is that there will be no difference either in the retention rate or caries prevention of giomer based sealant with and without treatment by bioactive glass air abrasion in young adults
Research question
In deep retentive fissures Will the use of bioactive glass air abrasion particles improve the retention rate and caries prevention of the giomer based sealant
Methodology
In Group 1 the self-etch primer BeautiSealant Primer Shofu Japan will be applied to the occlusal fissures with a fine micro brush After waiting for 5 s gently air blow for about 3 sec and then dry with stronger stream of air until a thin and uniform bonding layer is obtained The giomer sealant In Group 2 occlusal surface will be subjected to 5s of bioglass AquaCare- Velopex International then sealant BeautiSealant Paste Shofu Japan will be applied as aforementioned steps and light-cured for 20 s In both groups the surfaces were checked with an explorer to ensure that no voids were present The occlusion was checked and if necessary adjusted
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None