A Two-year Study Evaluating the Surface-sealed Cervical Resin Composite Restorations in Comparison With the Non-sealed Restorations
Clinical Effectiveness of Using Surface Sealants on Cervical Resin Composite Restorations in Comparison With Non-sealed Restorations: A 2-year Randomized Clinical Trial
After finishing and polishing are completed, the tooth surface may exhibit microcracks and micro-irregularities that create a roughened surface, which may lead to plaque retention, gingival inflammation, and discoloration. The surface-penetrating sealant was introduced to fill micro-irregularities by capillary action, providing a uniform, regular surface and enhancing the surface smoothness. The application of unfilled low-viscosity surface sealants aims to enhance the luster, smoothness, and color stability of esthetic restorations and decrease stain absorption. They have low viscosity that enables them to easily spread and penetrate over these finished and polished surfaces, which may affect the life of the restoration positively. Additionally, it decreases surface porosity and creates a surface that is more thoroughly cured, improving the composite's stain resistance.
This prospective, parallel-group, randomized clinical study aims to compare the clinical effectiveness of using surface sealants on cervical resin composite restorations versus non-sealed restorations. Restorations will be assessed at baseline, 6, 12, 18, and 24 months using modified USPHS criteria. The primary outcome will be assessing marginal discoloration, and the secondary outcomes will be assessing color match, secondary caries, postoperative sensitivity, surface texture, and marginal adaptation. Color stability will be assessed by VITA Easyshade®.
연구 개요
상태
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Nanees Ayman Hassan Aly
- 전화번호: 01210974750
- 이메일: nanees.ayman@dentistry.cu.edu.eg
참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
Participant Inclusion Criteria:
- Adult patients aged 18-55 years.
- Patients with good oral hygiene (mild to moderate plaque accumulation).
- Patients with asymptomatic class V cavities in permanent teeth.
Teeth inclusion criteria:
- Vital posterior teeth with class V carious cavities.
- Moderate cavities (ICDAS 3 & 4).
- Free from signs and symptoms of irreversible pulpitis and pulpal necrosis.
- Teeth with no or grade 1 mobility.
Participant Exclusion Criteria:
- Patients who are unable to return for recall appointments.
- Patients with poor oral hygiene.
- Presence of abnormal oral, medical, or mental condition
- Presence of any parafunctional habits.
- Patients with TMJ problems.
Teeth Exclusion Criteria:
- Periodontal disease that may affect the prognosis of the restoration or the tooth itself.
- Fractured or visibly cracked teeth.
- Presence of any developmental or formative defects.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Unfilled resin surface sealant group
Patients with carious cervical lesions (class V) in the esthetic zone receiving resin composite restorations covered by the Unfilled resin surface sealant
|
Unfilled resin surface sealant
|
|
실험적: Nano-filled resin surface sealant group
Patients with carious cervical lesions (class V) in the esthetic zone receiving resin composite restorations covered by the Nano-filled resin surface sealant
|
Unfilled resin surface sealant
|
|
활성 비교기: Class V Restorations without resin surface sealants.
Patients with carious cervical lesions (class V) in the esthetic zone receiving resin composite restorations not covered by the resin surface sealant
|
Restorations without resin surface sealants.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Marginal discoloration
기간: 2 years
|
Modified USPHS criteria
|
2 years
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Color match, Secondary caries, Postoperative sensitivity, Surface texture , Marginal adaptation
기간: 2 years
|
Modified USPHS criteria
|
2 years
|
|
Color stability
기간: 2 years
|
by VITA Easyshade®
|
2 years
|
공동 작업자 및 조사자
스폰서
간행물 및 유용한 링크
일반 간행물
- • Amin, A. H., Yaakob, M. H., Nasir, W. Z. W., & Al-Kadhim, A. H. A. (2018). Evaluation the correlation between age, gender, and the incidence of cervical lesions. Journal of Clinical Research in Dentistry, 1(1). • Attia, R. M., Sobhy, E. M., & Abd El Hameed, M. E. S. (2023). Micro-Hardness and Surface Roughness of Bulk-Fill Composite Resin: Effect of Surface Sealant Application and Two Bleaching Regimens. European Journal of General Dentistry, 12(03), 169-176. • Calazans, F. S., Ferreira, T. D. M. J., Ñaupari-Villasante, R., Mendonça, R. P., Ornellas, G., Albuquerque, E. G., ... & Loguercio, A. D. (2024). Influence of surface sealants on the quality of posterior restorations with bulk-fill composites: A 4-year randomized clinical trial. Dental Materials, 40(3), 466-476. • Dawoud, B., Abou-Auf, E., & Shaalan, O. (2025). 24-Month clinical evaluation of cervical restorations bonded using radio-opaque universal adhesive compared to conventional universal adhesive in carious cervical lesions: A randomized clinical trial. Scientific Reports, 15(1), 5505. • Demarco, F. F., Collares, K., Coelho-de-Souza, F. H., Correa, M. B., Cenci, M. S., Moraes, R. R., & Opdam, N. J. (2015). Anterior composite restorations: A systematic review on long-term survival and reasons for failure. Dental materials, 31(10), 1214-1224. • de Melo Soares, V., de Oliveira Bomfim, H. L. Q., Romão, D. A., de Moraes Porto, I. C. C., & de Mendonça Fragoso, L. S. (2024). Comparative Analysis of Different Methods of Marginal Microleakage Evaluation for Restored Teeth by Composite Resin. Journal of Health Sciences, 26(4), 221-225. • Elwassefy, N., ElEmbaby, A., & Elkholany, N. (2023). Correlation between surface roughness and color stability of nano-and micro-hybrid resin composites using different surface treatment protocols. Egyptian Dental Journal, 69(1), 705-713.
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
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- Surface sealants on composite
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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PermaSeal™, Ultradent Products Inc., USA에 대한 임상 시험
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University of California, San Diego알려지지 않은
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Cairo University아직 모집하지 않음