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
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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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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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
- Volwassen
Accepteert gezonde vrijwilligers
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Actieve vergelijker: 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
Andere namen:
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Actieve vergelijker: 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
Andere namen:
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Actieve vergelijker: 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
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Loss of sealant's retention
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Secondary Caries
Tijdsspanne: 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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Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- Fissure sealant
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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