Evaluation of Gingival Displacement With RACESTYPTINE Solution and RACEGEL: a Prospective, Comparative Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Septodont
- 入组人数
- 88
- 试验地点
- 9
- 主要终点
- Quantitative assessment of the lateral gingival displacement
研究概览
简要总结
The study design is a prospective, multi-center randomized, controlled, open label, 3-arm parallel group, post market clinical follow-up (PMCF) Clinical Trial.
The aim of the study is to collect clinical performance and safety data from RACEGEL and RACESTYPTINE Solution. Three gingival retraction techniques are being studied: RACESTYPTINE Solution with cord, RACEGEL with cord and RACEGEL without cord.
The study will demonstrate the expected performance of these 3 techniques in terms of sulcus opening, i.e. a lateral gingival displacement of at least 200 µm (state of the art) allowing the realization of pre-prosthetic impression with subgingivally margins. 90 subjects (teeth) requiring a dental restoration with subgingival margins for placement of a fixed prosthesis will be enrolled in 3 groups (30 in each group). For each participant, two dental impressions are performed: one impression before the gingival retraction and one impression immediately after the gingival retraction. Both impressions are scanned with 3D dental scanner and images are superimposed before analysis of tissue displacement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Blinding will be done to the assessors who analyzed dental impression to reduce bias to gingival tissue displacement assessment
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult male or female (age ≥18 years),
- •Patient requiring a dental restoration with subgingival margins on one or more teeth with placement of a single or multiple fixed prosthesis. Partially edentulous patients can be enrolled.
- •Good oral hygiene
- •Healthy periodontium and gingiva: probing depth ≤3 mm, no evidence of gingival inflammation (gingival index ≤ 1), attachment loss (attached gingival >2 mm), bleeding on probing, or plaque accumulation (plaque index < 3)
- •Patient who received information and gave written consent.
- •Patient affiliated with a social security/protection plan.
排除标准
- •Contraindication to taking impression evidenced at the latest on the day of inclusion visit (gingival index ≥2, sign of attachment loss or tooth mobility, probing depth >3 mm).
- •Known allergy to aluminum, aluminum salts or to one of the compounds of the formula of the gingival retraction material, or to one of the compounds of the impression material.
- •Patient with an unbalanced systemic disease (diabetes, thyroid disorders, history of oropharyngeal cancer),
- •Simultaneous participation in another interventional clinical investigation or trial,
- •Vulnerable Subjects
结局指标
主要结局
Quantitative assessment of the lateral gingival displacement
时间窗: Day 0
Two dental impressions are performed per participant at the same visit : one impression before the gingival retraction and one impression immediately after the gingival retraction. Both impressions are scanned with 3D dental scanner and images are superimposed before analyses. The lateral gingival displacement corresponds to the difference between pre- and post-displacement sulcus width measured in the 2 superimposed images of the pre- and post-retraction scanned models.
次要结局
- Papilla Bleeding index(Day 0 (before and after the gingival retraction), Day 14 (end of study visit))
- Probing depth(Day 0 (before and after the gingival retraction), Day 14 (end of study visit))
- Quantitative assessment of the vertical gingival displacement(Day 0)
- Oozing control assessment(Day 0)
- Gingival index(Day 0 (before and after the gingival retraction), Day 14 (end of study visit))
- Bleeding control assessment(Day 0)
- Adverse events(Day 0, Day 14 (end of study visit))