Preservation of the Alveolar Ridge Using a Cortical Lamina After Tooth Extraction: A Randomized Controlled 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
- Change in Alveolar Ridge Width and Height
研究概览
简要总结
This randomized controlled clinical trial aims to evaluate the efficacy of placing a cortical lamina between the elevated flap and buccal bone plate following tooth extraction for preserving alveolar ridge dimensions. Forty patients will be randomly assigned to either the test group (lamina placement) or control (no intervention). Changes in ridge width and height will be assessed using CBCT and 3D digital models after six months.
详细描述
Alveolar bone resorption after tooth extraction can compromise prosthetic and implant rehabilitation by reducing both bone height and width, especially at the buccal plate. Various alveolar ridge preservation (ARP) techniques have been proposed to minimize these dimensional changes; however, their clinical predictability and long-term benefit remain debated.
This randomized controlled clinical trial aims to evaluate the efficacy of placing a cortical lamina between the elevated mucoperiosteal flap and the buccal bone plate immediately after tooth extraction to preserve alveolar ridge dimensions. The technique is intended to limit post-extraction resorption by temporarily isolating the periosteum from the underlying bone, promoting favorable bone remodeling and contour maintenance for subsequent implant placement.
Forty patients requiring the extraction of single teeth (premolars, canines, or maxillary incisors) will be enrolled and randomly allocated into two groups:
Test group: A cortical lamina will be inserted between the buccal bone and the flap following tooth extraction.
Control group: Extraction sites will be left untreated to heal spontaneously.
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
- Single (Outcomes Assessor)
盲法说明
Participants and surgeons will know group allocation; however, the radiographic examiner assessing outcomes will remain blinded to reduce bias.
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Presence of a tooth indicated for extraction (maxillary incisors, canines, or premolars in either jaw).
- •Age ≥ 21 years.
- •Good general health with no contraindications for oral surgery.
- •Non-pregnant individuals.
- •Willingness to participate and sign written informed consent.
排除标准
- •Uncontrolled systemic disease (e.g., diabetes mellitus, hypertension).
- •History of chemotherapy or radiotherapy.
- •Current smokers of more than 10 cigarettes per day.
- •Sites previously treated with regenerative or augmentation procedures.
- •Poor oral hygiene or active periodontal infection.
结局指标
主要结局
Change in Alveolar Ridge Width and Height
时间窗: Baseline (immediately post-extraction) to 6 months after extraction
Linear dimensional changes in the alveolar ridge (horizontal width and vertical height) will be evaluated using cone-beam computed tomography (CBCT) images taken immediately after tooth extraction (baseline) and six months post-surgery. Measurements will be made at standardized reference points on cross-sectional CBCT slices to quantify resorption or preservation of bone.
次要结局
- Volumetric Change of the Alveolar Ridge(Baseline to 6 months post-extraction)