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
연구 개요
상세 설명
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
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Cairo, 이집트
- Faculty of Dentistry
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Cairo, 이집트
- Yomna
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Cairo, 이집트
- Faculty of Dentistry Cairo University
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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활성 비교기: 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
다른 이름들:
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활성 비교기: 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
다른 이름들:
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활성 비교기: 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
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Loss of sealant's retention
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Secondary Caries
기간: 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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공동 작업자 및 조사자
스폰서
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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