Comparative evaluation of gingival deflection using the novel cordless gingival retraction paste with three commercially available cordless gingival retraction pastes and nonimpregnated retraction cords: An in vivo study
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- The novel herbal cordless gingival retraction paste proposed in this protocol is designed to be biocompatible, cost-effective, and environmentally friendly, addressing limitations of existing commercial products. If the invitro and an inVivo results confirm adequate retraction and safety, this paste could provide a valuable alternative as gingival retraction material.
研究概览
简要总结
Aim: To evaluate the efficacy of a novel herbal cordless gingival retraction paste in comparison with three different commercially available cordless retraction pastes and non-impregnated retraction cords.
Material and methods:
A two-phase experimental clinical study will be conducted. The study includes (1) formulation and invitroevaluation of a novel herbal cordless gingival retraction paste, (2) safety assessment via cytotoxicity assay on animal tissue, and (3) an InVivo comparison of gingival displacement efficacy among the novel paste, three commercial cordless pastes, and a non-impregnated retraction cord in 30 healthy adult participants. Gingival displacement will be measured using digital impressions and stereomicroscopic analysis. Statistical analysis will be performed using ANOVA and post hoc tests.
Results: The study will primarily focus on the formulation and in vitro evaluation of a novel gingival retraction paste, followed by animal studies to assess its safety and efficacy. Subsequently, a clinical trial will be conducted to compare gingival displacement among experimental and control groups. The mean gingival displacement for each participant will be recorded. The cross-sectional dimensions (buccolingual [BL] and mesiodistal [MD]) of each sample tooth on the model will be analyzed under a stereomicroscope to quantify gingival retraction.
Conclusion: This study aims to provide evidence for a novel, biocompatible, and cost-effective gingival retraction paste, potentially improving clinical outcomes and patient care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Participants aged 18 years and above Teeth requiring preparation for full coverage restoration Sound gingival and periodontal health of the abutment teeth.
- •Abutment teeth with normal size and contour (no developmental anomalies or regressive age-related changes) Abutment teeth selected from the maxillary anterior region.
排除标准
- •Tipped, tilted, or rotated abutment teeth Presence of any gingival pathology Individuals with a thin gingival biotype Diastema or restored anterior teeth Systemic diseases o Known allergy to materials used • Pregnant or lactating women.
结局指标
主要结局
The novel herbal cordless gingival retraction paste proposed in this protocol is designed to be biocompatible, cost-effective, and environmentally friendly, addressing limitations of existing commercial products. If the invitro and an inVivo results confirm adequate retraction and safety, this paste could provide a valuable alternative as gingival retraction material.
时间窗: Eligibility Check-Baseline | Baseline Pre intervention assessment, clinical photographs, randomization. | Intervention: | Group A: Novel gingival retraction material (Day 1) | Group B: Expasyl (Day 7) | Group C: 3M ESPE paste (Day 14) | Group D: No cord paste (Day 21) | Control Group: Non impregnated cord (Day 28)
次要结局
- 1.To compare and evaluate the efficacy of innovative herbal cordless gingival retraction(paste with the commercially available Expasyl retraction system.)
研究者
Dr ABHIJIT ANIL TAMBE
GDC and H,CHH SAMBHAJINAGAR