Fissure Sealant Retention Trial (FSRT)
Split Mouth Clinical Trial of Fissure Sealant Retention With Self Etching and Total Etch Bonding Agent
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Pit and fissure sealant have been hailed as a highly effective preventive dental treatment since it was introduced first in late 1970s . Sealants have traditionally placed using two step bonding agents based on acid etching with phosphoric acid followed by drying and bonding agent application and curing. Multiple steps in application of bonding agents have been associated with more chances of procedure errors and prolonged procedure time. The newer bonding agents are based on minimizing the number of steps involved with introduction of self etching bonding agents.6th generation adhesives are based on mixing of two components where as the 7th generation adhesives are based on no mix technique.
Previous studies on fissure sealants have focused on conventional etch and rinse bonding agents, there are only few published studies on effectiveness of the self etch bonding agents in retention of fissure sealants in vivo that have targeted the 6th generation adhesive. Feigal and Quelhas reported equivocal results with use of self etching bonding agents in comparison with etch and rinse bonding agents, but their study was limited by smaller sample size. Similar study was conducted by Burbridge which was based on short clinical follow up of 6 month evaluation where Xeno III by Dentsply (6th generation bonding agent) was compared with Prime & Bond (Dentsply). Another study by Venker et al on Adper Prompt L Pop in a school sealant program was based on retrospective review of cases. In light of published literature on (6th generation) self etch bonding agent has been found to be equal or inferior to total etch bonding agents (5th generation). There are no published clinical trials on the retentiong rate comparison of total etch bonding agent with no mix slef etch bonding agents in pit and fissure sealant.
Our study is based on comparison of effectiveness of single step bonding agent (7th generation adhesives) versus two step bonding agent in fissure sealant retention.
Type d'étude
Inscription (Anticipé)
Phase
- Phase 2
- Phase 3
Contacts et emplacements
Lieux d'étude
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Sindh
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Karachi, Sindh, Pakistan, 3500
- Recrutement
- The Aga Khan University Hospital
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Contact:
- Nadia Aman, BDS
- Numéro de téléphone: 5011 (92)214930051
- E-mail: nadia.aman@aku.edu
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Chercheur principal:
- Nadia Aman, BDS
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Sous-enquêteur:
- Ali K Khuwaja, FCPS
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Sous-enquêteur:
- Farhan R Khan, FCPS
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Fully erupted bilateral first or second permanent molar teeth.
- Patients requiring fissure sealant due high caries risk.
- Age group 6-25 years.
- Occlusal fissures of molar teeth.
Exclusion Criteria:
- Cases where one of the molar on either side is grossly carious or restored
- Third molars
- Uncooperative patients
- Molar teeth with antagonist tooth not present or extracted
- Mentally and physically handicapped patients
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation factorielle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Comparateur actif: 1
application of total etch bonding agent ( 5th generation) for placement of resing based pit and fissure sealants.
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Selected teeth would receive prophylaxis with pumice using prophylaxis brushes for 20 seconds. The teeth will be isolated with cotton rolls before application of bonding agent. The tooth selected for etch and rinse bonding system (two step bonding agent) will be treated with 37% phosphoric acid (Total Etch Ivoclar Vivadent) for 15 seconds followed by rinsing for 30 seconds and then drying with air syringe till frosty white appearance is achieved. Adper Single Bond 2 (3M ESPE) will be applied to occlusal fissure using applicator brushes followed by curing for 10 seconds. Clinpro(3M ESPE) fissure sealant will be applied to pits and fissures and then light cured for 20 seconds.
Autres noms:
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Expérimental: 2
Self etch bonding agent (7th generation) application for placement of resin based pit and fissure sealant
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For teeth selected for application of self etching bonding agent (Adper Easy Bond 3 M), the bonding agent will be applied to occlusal surface with microbrushes and will be left undisturbed for 20 seconds followed by air drying for 5 seconds and then will be light cured for 10 seconds.
Fissure sealant (Clinpro 3M ESPE) will be applied in a similar manner as for etch and rinse group and light cured.
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
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fissure sealant loss
Délai: 3months
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3months
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
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fissure sealant loss
Délai: 6months
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6months
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Nadia Aman, BDS, The Aga Khan University Hospital
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- 07GS028SUR
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