Efficacy of Acellular Dermal Matrix Versus Tenting Technique in Peri-implant Soft Tissue Augmentation and Crestal Bone Stability: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Crestal Bone Levels
研究概览
简要总结
This study looks at two ways to make gums thicker and bones stable around dental implants for people with thin gums. It compares two methods in 40 people: one method uses a special graft, and the other uses a technique called tenting. The goal is to see which method might work better for making the gums and bones around implants healthier. The check-ups are planned when the implant is put in and again after one year. The study focuses on how these methods are done without talking about what the results are.
详细描述
The study's protocol entails a randomized comparison between acellular dermal matrix grafting and the tenting technique, aimed at enhancing gum thickness and bone stability around dental implants in individuals with thin gum profiles. Forty participants are systematically assigned to one of the two methods under investigation. The study is structured to evaluate the interventions' potential in improving conditions conducive to the success of dental implants, specifically targeting soft tissue thickness and crestal bone level stability. The comprehensive investigation is designed to explore effective approaches for managing patients with particular soft tissue challenges, focusing on the clinical application and procedural aspects without presenting any results or conclusions.
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
- Double (Participant, Care Provider)
盲法说明
double-blind, where neither the patients nor the clinicians responsible for treatment know the specific treatment modality
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female patients between 18-75 years old.
- •Physical and psychological capacity to undergo implant therapy (ASA I or II).
- •Fully healed single mandibular posterior treatment sites (premolars or molars) being edentulous for at least 3 months.
- •Minimum of 6 mm width and 8 mm height native bone ridge.
- •No requirement for concomitant or a history of regenerative treatments.
- •Minimum of 4mm keratinized mucosa at the implant site (2 mm buccal and 2mm lingual).
- •Healthy non-inflamed keratinized soft tissues with a maximum soft tissue thickness height of 2 mm measured at crestal buccal and lingual aspects.
- •Periodontally healthy by fulfilling all of the following criteria: Full-mouth bleeding score (FMBS) < 20%, Full-mouth plaque score (FMPS) < 15%, Community Periodontal Index of Treatment Needs (CPITN) < 2.
排除标准
- •Patients with a history of periodontitis.
- •Poor oral hygiene after Oral Hygiene Instructions (OHI).
- •Pregnant or lactating.
- •Uncontrolled concomitant medical diseases, e.g., diabetes.
- •Receiving or having received pharmacological treatment affecting wound healing within 3 months prior to the study-related intervention.
结局指标
主要结局
Crestal Bone Levels
时间窗: Baseline - 1year follow up
Assessment of changes in crestal bone level (CBL)
次要结局
- Vertical soft tissue thickness(Measured from before implant placement to implant uncovering at 2 months)
- PPD(Baseline - 1year follow up)
- PI(Baseline - 1year follow up)
- BOP(Baseline - 1year follow up)
研究者
German O. Gallucci
Associate Professor and Chair Department of Restorative Dentistry and Biomaterials Sciences
Harvard Medical School (HMS and HSDM)