Effect of Theravex Tissue Care on Implant Stability in Immediate Implant Placement: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Implant Stability Quotient (ISQ)
研究概览
简要总结
The aim of this randomized clinical trial is to evaluate the clinical and radiographic outcomes of using Bone Bioactive Liquid (Theravex) compared to Xenograft and a combination therapy (Theravex + Xenograft) during immediate implant placement in the esthetic zone.
When a tooth is extracted and replaced immediately with a dental implant, bone grafting is often necessary to fill the gap (jumping distance) between the implant and the surrounding bone socket to support tissue healing and maintain facial contour.
Participants requiring immediate implant placement will be randomly assigned into three groups:
Group 1: Immediate implant placement using Bone Bioactive Liquid (Theravex).
Group 2: Immediate implant placement using Xenograft alone.
Group 3: Immediate implant placement using Combination Therapy (Theravex + Xenograft).
The primary outcomes will evaluate implant stability, bone dimensional changes, and soft tissue response around the implants over the follow-up period.
详细描述
Background and Rationale:
Immediate implant placement in extraction sockets has become a widely accepted clinical protocol due to reduced treatment time, fewer surgical interventions, and preservation of surrounding hard and soft tissue architecture. However, post-extraction bone remodeling often leads to horizontal and vertical dimensional changes, particularly at the buccal bone plate. To counteract these changes and ensure long-term stability and esthetics, grafting the peri-implant defect (jumping space) is commonly performed.
Study Objectives:
The main objective of this study is to compare the efficacy of Bone Bioactive Liquid (Theravex), Xenograft material, and their combination in enhancing early osseointegration, maintaining bone dimensions, and supporting peri-implant tissue health during immediate implant placement.
Methodology:
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient requires extraction of a single failing or non-restorable maxillary anterior tooth or premolar.
- •Presence of an intact buccal bone plate (Socket Type I) with a horizontal peri-implant jumping gap ≥ 2 mm.
- •The implant can be placed in an ideal 3-D position with an intraoperative primary stability target of ≥ 35 Ncm.
- •Patient is in good general health with no systemic contraindications to implant surgery.
- •Patient is cooperative and available for the entire 6-month follow-up period
排除标准
- •Pregnant and lactating females.
- •Heavy smokers (smoking ≥ 10 cigarettes per day).
- •Patients with poor oral hygiene.
- •Patients with occlusal or malalignment problems.
- •Patients with parafunctional habits (e.g., bruxism).
结局指标
主要结局
Implant Stability Quotient (ISQ)
时间窗: Baseline (during surgery), 4 weeks, 3 months, and 6 months post-operatively.
Implant stability will be measured using Resonance Frequency Analysis (RFA) to record the Implant Stability Quotient (ISQ) values.
次要结局
- Bone Density(6 months post-operatively.)
- Mid-facial Gingival Margin Level(Baseline (immediately post-operative), 3 months, and 6 months post-operatively.)
- Oral Health-Related Quality of Life (OHIP-14)(Pre-operatively (baseline), 7 days, 3 months, and 6 months post-operatively.)
研究者
Abdallah Abdelnabi
Assistant Lecturer of Periodontology
Ain Shams University