Clinical Study on the Efficacy of Theravex Oral and Theravex Tissue Care Plus in Periodontal Surgery" Modified Free Gingival Graft for the Treatment of RT1-RT2: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Recession depth reduction
研究概览
简要总结
This clinical study assesses the efficacy of two novel bioactive solutions, Theravex Oral and Theravex Tissue Care Plus, in enhancing soft tissue healing after periodontal surgery. The study focuses on patients undergoing a Modified Free Gingival Graft (M-FGG) technique to treat gingival recessions around mandibular incisors. Participants are randomly assigned to a test group receiving the Theravex treatment or a control group receiving a saline placebo. The primary goal is to measure the impact of these solutions on root coverage and other key outcomes, such as tissue gain, color integration, and postoperative pain, over a one-year period.
详细描述
Background and Rationale:
Gingival recession is a common condition often leading to aesthetic concerns and dentin hypersensitivity. While Free Gingival Graft (FGG) is a standard procedure to halt recession, it often lacks aesthetic predictability. This study investigates a novel Bone Bioactive Liquid (BBL) solution, containing calcium chloride and magnesium dichloride hexahydrate, which has shown preclinical advantages in hard and soft tissue regeneration.
Study Design and Methodology:
This is a randomized, double-blind clinical trial conducted at the Complutense University of Madrid. Subjects with at least one RT1-RT2 gingival recession around mandibular incisors are recruited based on specific inclusion and exclusion criteria, including periodontal health and non-smoking status.
Intervention:
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Healthy patients aged ≥ 18 years.
- •Patients with at least one mandibular incisor presenting a gingival recession RT1-RT2 and requiring a free gingival graft.
- •Periodontal health in either an intact or reduced periodontium (Chapple et al., 2018) with a plaque index ≤ 20% (O'Leary et al., 1972).
- •Initial probing depth ≤ 3 mm in the treated teeth.
- •No dental mobility (grade ≤ 1) in the treated teeth.
- •Well-defined CEJ
- •Agreement to take part in this study (signed informed consent).
排除标准
- •Smokers ≥10 cigarettes/day.
- •Patients treated with Theravex [IS1.1][ma1.2]previously.
- •Untreated parafunctional habits.
- •Restorations that cannot be removed for proper treatment.
- •Pregnant patients or cases with uncertain pregnancy status (self-reported).
- •Patients with uncontrolled systemic diseases, neurological, psychiatric disorders, or other known conditions capable of influencing the results of the study.
- •Patients not attending follow-ups or not signing informed consent.
研究组 & 干预措施
Theravex Oral and Theravex Tissue Care Plus
Subjects receive a Modified Free Gingival Graft (M-FGG). Immediately after graft harvesting, 0.5 ml of Theravex Tissue Care Plus is applied to the graft for 5 minutes. Before graft placement, 0.5 ml of the solution is applied to the recipient site. Post-surgically, patients rinse with 5 ml of Theravex Oral for 30 seconds immediately after surgery, followed by twice-daily rinsing for 14 days
干预措施: Modified Free Gingival Graft (M-FGG) (Procedure)
Theravex Oral and Theravex Tissue Care Plus
Subjects receive a Modified Free Gingival Graft (M-FGG). Immediately after graft harvesting, 0.5 ml of Theravex Tissue Care Plus is applied to the graft for 5 minutes. Before graft placement, 0.5 ml of the solution is applied to the recipient site. Post-surgically, patients rinse with 5 ml of Theravex Oral for 30 seconds immediately after surgery, followed by twice-daily rinsing for 14 days
干预措施: Theravex Bioactive Solutions (Tissue Care Plus and Oral) (Drug)
Control Group
Subjects receive the same Modified Free Gingival Graft (M-FGG) surgical procedure. In place of the active agent, the graft is submerged in a blinded saline solution (placebo), and the recipient site is irrigated with the same placebo. Post-surgically, patients rinse with a blinded 0.05% cetylpyridinium chloride solution twice daily for 2 weeks.
干预措施: Modified Free Gingival Graft (M-FGG) (Procedure)
结局指标
主要结局
Recession depth reduction
时间窗: Baseline, 1 month, 3 months, 6 months, and 12 months post-surgery.
Recession Depth reduction is a calculated variable. It is determined by subtracting the Recession Depth measured at the follow-up visits from the Baseline (BL) Recession Depth (RD reduction = BL RD - Follow-up RD). Measurements are taken mid-buccally.
次要结局
- Soft Tissue Thickness (STT)(Baseline, 1 month, 3 months, 6 months, and 12 months.)
- Recession Depth (RD)(Baseline, 1 month, 3 months, 6 months, and 12 months.)
- Recession Width (RW)(Baseline, 1 month, 3 months, 6 months, and 12 months.)
- Keratinized Tissue Width (KTW)(Baseline, 1 month, 3 months, 6 months, and 12 months.)
- Microvascular Perfusion (LSPU)(Preoperatively, immediately after surgery, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 12 months)
- Gingival Color Difference (Delta E)(Preoperatively, 1 week, 2 weeks, 4 weeks, 3 months, 6 months, and 1 year)
- Soft Tissue Volume Change(Preoperatively, immediately after surgery, 2 weeks, 1 month, 3 months, 6 months, and 12 months.)