Effect of Reducing the Time Interval for Implant Placement After Extraction Socket Preservation Using the Vega Plus Implant System (Klockner): A Randomized Controlled Clinical Trial
概览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Universidad Catolica Santiago de Guayaquil
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Mean change in horizontal alveolar ridge width (mm) measured by cone-beam computed tomography (CBCT)
概览
简要总结
This randomized controlled clinical trial aims to evaluate whether reducing the healing interval for implant placement after extraction socket preservation improves clinical and radiographic outcomes compared with the conventional waiting period. Participants requiring single-tooth extraction and implant therapy will be randomly assigned to implant placement either 4 months or 6 months after ridge preservation using the Vega Plus implant system (Klockner).
Clinical and radiographic assessments will be performed at baseline and during follow-up visits. The primary outcome will be the mean change in horizontal alveolar ridge width measured using cone-beam computed tomography (CBCT). Secondary outcomes will include vertical bone height changes measured on CBCT, implant stability measured using resonance frequency analysis (ISQ values), marginal bone level changes assessed on standardized periapical radiographs, and postoperative pain assessed using the Visual Analog Scale (VAS).
The results of this study may contribute to optimizing treatment timing and improving efficiency in implant dentistry while maintaining favorable clinical outcomes.
详细描述
The optimal interval between treatment phases remains uncertain in several clinical settings. Traditional protocols often include a waiting period between phases to allow tissue healing or stabilization; however, prolonged intervals may extend overall treatment time and potentially affect patient adherence and outcomes. Emerging evidence suggests that reducing the interval between phases could maintain clinical effectiveness while improving efficiency and patient satisfaction. This randomized controlled trial will compare a reduced-interval protocol with a conventional-interval protocol. Eligible participants who require multi-phase treatment will be randomized into two groups: (1) reduced-interval treatment and (2) standard-interval treatment. Clinical examinations will be conducted at baseline and at scheduled follow-up visits according to the study protocol.
Primary outcomes will assess clinically relevant parameters associated with the treated condition. Secondary outcomes will evaluate treatment duration, patient-reported symptoms, and quality-of-life measures. Statistical analyses will compare outcomes between groups to determine whether the reduced-interval approach provides equivalent or improved results compared with the conventional schedule.
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
- None
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
- •Age: ≥ 18 years.
- •Good general health.
- •Need of extraction of incisors, canines or premolars due to carious lesion, endodontic complication, root fracture or prosthetic reason.
- •Presence of three intact socket walls after tooth extraction with a defect of 50% or more of the buccal wall.
- •Need of single-tooth implant treatment, with presence of adjacent teeth and opposing occluding teeth (for measurement stent indexing).
- •Enough available bone assessed on CBCT to place implants with 3.6 mm diameter and 10 mm in length.
- •Periodontal health in intact or reduced periodontium.
- •Full-mouth plaque and bleeding scores \< 20%.
- •Able and willing to follow study procedures and instructions.
排除标准
- •\< 18 years.
- •Compromised health. Existence of any systemic condition such as uncontrolled diabetes mellitus, cancer, HIV, disorders that compromise wound healing, chronic high dose steroid therapy, intravenous and oral bisphosphonate therapy, bone metabolic diseases, history of irradiation of the head and neck area, or any other immunosuppressive therapy that would contraindicate oral surgical treatment.
- •Absence of any adjacent teeth or the opposing occluding teeth.
- •The hopeless tooth is a molar.
研究组 & 干预措施
Reduced time Interval treatment protocol
Participants receive implant placement after extraction socket preservation using a reduced healing interval according to the experimental protocol.
干预措施: Reduced time interval treatment protocol (Procedure)
Standard Time Interval
Participants receive treatment following the conventional interval protocol used in routine clinical practice.
干预措施: Standard time interval treatment protocol (Procedure)
结局指标
主要结局
Mean change in horizontal alveolar ridge width (mm) measured by cone-beam computed tomography (CBCT)
时间窗: Baseline (immediately after ridge preservation surgery) to 6 months after surgery (prior to implant placement)
Horizontal alveolar ridge width will be measured in millimeters using cone-beam computed tomography (CBCT). Measurements will be obtained at three standardized levels (1 mm, 3 mm, and 5 mm below the crestal bone). Baseline and follow-up CBCT scans will be superimposed, and the mean change in ridge width (mm) between time points will be calculated.
次要结局
- Mean change in vertical alveolar bone height (mm) measured by cone-beam computed tomography (CBCT)(Baseline (immediately after ridge preservation surgery) to 6 months after surgery (prior to implant placement))
- Mean implant stability quotient (ISQ) measured using resonance frequency analysis (Osstell IDx)(Implant placement to prosthetic loading (approximately 3 months))
- Mean marginal bone level change (mm) measured on standardized periapical radiographs(Implant placement to 2 years after prosthetic loading)
- Mean postoperative pain score measured using the Visual Analog Scale (VAS, 0-10)(24 hours to 14 days after implant placement surgery)
研究者
Gabriela Guadalupe Zambrano Manzaba
Specialist in Periodontology
Universidad Catolica Santiago de Guayaquil