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临床试验/CTRI/2026/01/100382
CTRI/2026/01/100382尚未招募1 期

Comparative Clinical Assessment of Proximal Contacts and Contours in Class II Posterior Restorations Using Three Matrix Systems: Randomised Clinical Trial.

Manipal College of Dental Science,Mangalore1 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2026年1月16日最近更新:

试验速览

阶段
1 期
状态
尚未招募
发起方
入组人数
21
试验地点
1
主要终点
1• Proximal contact tightness will be assessed using FDI criteria via the dental floss test and categorised as optimum, tight or open.

研究概览

简要总结

Introduction: Achieving proper proximal contact and contour in Class II composite restorations is essential for maintaining tooth stability and preventing food impaction. Composite resin materials and matrix design influence the final proximal contact quality. Traditional circumferential matrices often result in open contacts, whereas sectional and saddle matrices provide better separation and contour. This study aims to compare proximal contact tightness and contour accuracy using Tofflemire, Palodent V3, and Saddle matrix systems based on FDI criteria.

Objectives: Primary objective: To compare proximal contact tightness and proximal contour quality using the three matrix systems. Secondary objective: To assess radiographic overhang formation among the three systems.

Methods: Trial design: Parallel arm randomized clinical trial with three groups. Setting: Department of Conservative Dentistry and Endodontics, MCODS, Mangalore. Participants: Adults aged 18 years and above with supragingival Class II lesions limited to one third intercuspal distance. Teeth must have an adjacent natural tooth with a contact point. Exclusion criteria include deep lesions, tooth mobility, periodontal disease, spacing, crowding, or existing adjacent restorations.

Interventions: Group 1: Tofflemire matrix system. Group 2: Palodent V3 sectional matrix system. Group 3: Saddle matrix system. All teeth will be isolated using a rubber dam, prepared using standardized cavity procedures, bonded using total etch technique, restored with composite resin in increments, and finished and polished.

Outcome Measures: Primary outcomes include proximal contact tightness assessed by floss test and clinical FDI criteria, and radiographic presence of overhangs. Secondary outcomes include proximal contour accuracy and procedure-related ease.

FDI Contact Criteria: Optimum contact: Slight resistance. Tight contact: Hard to pass floss. Open contact: No resistance.

Sample Size: Twenty-one participants, seven per group.

Randomization: Block randomization with sequentially numbered opaque envelopes.

Blinding: Outcome assessor blinded. Operator and participants not blinded.

Statistical Analysis: Chi square test with significance at p less than 0.05.

Ethics and Dissemination: Ethics committee approval will be obtained. Data confidentiality will be maintained. Results will be shared through publications and scientific presentations.


研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • Participants will be eligible if 1.they are aged 18 years or older, 2.have fully erupted and occluding permanent posterior teeth with proximal contact present with compound Class II (MO or DO) 3.supragingival lesions involving one third or less of the intercuspal distance.

排除标准

  • Participants will be excluded if they: 1• Have complex Class II lesions, crowding/spacing, or tooth mobility 2• Present with periodontal disease 3• Have deep cavities or pulp involvement 4• Have previously restored adjacent proximal surfaces 5• Lack contact with the adjacent tooth 6.Do not provide informed consent.

结局指标

主要结局

1• Proximal contact tightness will be assessed using FDI criteria via the dental floss test and categorised as optimum, tight or open.

时间窗: at baseline

2• Radiographic evaluation of overhangs will be conducted using bitewing radiographs and classified as absent, positive or negative.

时间窗: at baseline

次要结局

  • 1. The study will evaluate differences among the three matrix systems in terms of proximal contour accuracy(FDI .criteria), radiographic overhang formation,operator handling/ease of placement & patient comfort with floss passage & food impaction.(Immediately post-restoration (single visit).)

研究者

发起方
Manipal College of Dental Science,Mangalore
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Meenu Goyat

Manipal College of Dental Science

研究点 (1)

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