Retention and Caries Prevention of Giomer Sealant With or Without Diode Laser Pre-treatment: A Randomized Controlled Trial
Retention Rate and Caries Prevention of Giomer Based Sealant With and Without Diode Laser Pre-treatment in Young Adults: A Randomized Controlled Trial
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
The protocol investigates whether diode laser pre-treatment can improve the clinical performance of a giomer-based fissure sealant in young adults. The study is designed as a two-arm randomized controlled clinical trial evaluating sealant retention and caries prevention over a 12-month period.
The background emphasizes that pits and fissures of posterior teeth are highly susceptible to caries, and fissure sealants are an evidence-based preventive approach. Giomer sealants combine the advantages of resin composites and glass ionomer materials through S-PRG filler technology, offering fluoride release and simplified application using self-etch primer systems. However, concerns remain regarding their long-term retention. Diode laser enamel pre-treatment is proposed to enhance enamel surface roughness, improve sealant penetration, and increase resistance to acid dissolution, potentially improving retention and caries prevention.
The study aims to compare giomer-based sealant application with and without diode laser pre-treatment in patients aged 17-22 years having deep retentive fissures with ICDAS scores 0-2 in second and third molars. Primary outcome is sealant retention assessed using Simonsen's criteria, while secondary outcome is caries prevention evaluated using modified USPHS criteria at baseline, 6 months, and 12 months.
The null hypothesis states that diode laser pre-treatment will not significantly affect retention rate or caries prevention compared with conventional application. The protocol includes detailed sample size calculation based on previous literature, resulting in 37 teeth per group after adjustment for dropouts. Statistical analysis will include chi-square and Cochran's Q tests with significance set at p ≤ 0.05.
Eligibility criteria include healthy young adults with good oral hygiene and absence of parafunctional habits. Teeth with fractures, existing restorations, secondary caries, developmental defects, or periodontal compromise are excluded.
Methodologically, participants are randomly allocated using opaque sealed envelopes. In the control group, self-etch primer is applied before placement of BeautiSealant. In the laser group, a 940-nm diode laser is first applied to the occlusal surface, followed by the same primer and sealant application protocol. All restorations are light-cured and clinically evaluated for voids and occlusion
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Cairo, Egypte
- Faculty of Dentistry
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Cairo, Egypte
- Yomna
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Cairo, Egypte
- Faculty of Dentistry Cairo University
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
Accepte les volontaires sains
La description
Inclusion Criteria:
Young adult Patients Aged 17-22.
- Good oral hygiene (plaque index score 0 or 1).
- Absence of abnormal occlusion habits (e.g. bruxism, nail biting, tooth clenching and mouth breathing).
- Patients approving to participate in the study.
Exclusion Criteria:
•Patients with known allergic or adverse reaction to the tested materials.
- Systematic disease that may affect participation.
- Xerostomic patients.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Comparateur actif: Giomer Based Sealant Without Pre Treatmen
Giomer Based Sealant Without Pre Treatment With laser giomer based fissure sealnt will be applied without surface treatment
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surface treatment with Bioactive Glass Air Abrasion giomer based fissure sealnt will be applied after surface treatment With laser
Autres noms:
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Comparateur actif: Giomer Based Sealant With etchant Pre Treatmen
Giomer Based Sealant Without Pre Treatment With laser giomer based fissure sealnt will be applied with phosphoric acid surface treatment
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surface treatment with Bioactive Glass Air Abrasion giomer based fissure sealnt will be applied after surface treatment With laser
Autres noms:
|
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Comparateur actif: Giomer Based Sealant With laser Pre Treatmen
Giomer Based Sealant with laser Pre Treatment giomer based fissure sealnt will be applied with laser surface treatment
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surface treatment with Bioactive Glass Air Abrasion giomer based fissure sealnt will be applied after surface treatment With laser
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Loss of sealant's retention
Délai: 1 year
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Simonsen's 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.
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1 year
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Secondary Caries
Délai: 1 year
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Modified USPHS ( United States Public Health Service) criteria Alpha: Absence of the caries Charlie: Presence of the caries
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1 year
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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- Fissure sealant
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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