Influence of Healing Time on the Outcomes of Alveolar Ridge Preservation in Periodontally Compromised Extraction Sockets: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Percentage of vital bone via histomorphometric evaluation of bone core biopsies at 3 months
研究概览
简要总结
The goal of this clinical trial is to histologically, clinically, and radiographically evaluate the healing sequelae of periodontally compromised extraction sockets grafted with Bio-Oss Collagen® at 3 and 6 months following tooth extraction in molar sites. The main question it aims to answer is:
Does healing time influence the histologic, clinical, and radiographic outcomes following socket grafting (alveolar ridge preservation) in periodontally compromised extraction sockets.
Researchers will compare a healing time of 3 months to a healing time of 6 months (conventional healing duration) to see if a shorter duration is viable for implant placement.
Participants will:
Take a cone-beam computed tomography (CBCT) scan to prepare for the surgical procedure.
Undergo tooth extraction and the extraction socket will be grafted with Bio-Oss Collagen® and a collagen membrane Bio-Gide® will be placed to stabilize the graft material.
Return at 2 weeks for suture removal and either 3- or 6-months post-extraction for implant placement.
Return at 2 weeks post-implant placement for suture removal, 3 months for prosthesis fabrication, 4 months for final prosthesis loading, and 1 year post-loading.
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
- •18 years of age or older
- •ASA (American Society of Anesthesia) status I or II
- •Need for molar extraction due to periodontal disease with or without chronic endodontic involvement, complying with the presentation of periodontitis stage III/IV
- •Radiographic evidence of a bone dehiscence on at least one socket wall, where the height of the horizontal (suprabony) component of the defect (alveolar bone crest - cement-enamel junction) is >50% of the corresponding root length as measured on CBCT scans prior to extraction (Ben Amara et al., 2021)
- •Radiographic evidence of at least 3 mm of residual bone wall height
- •Presence of at least one adjacent tooth to the extraction site
- •Treatment plan must include tooth replacement with an implant-supported fixed dental prosthesis
排除标准
- •Extraction of multiple adjacent teeth
- •Acute infection associated with the tooth to be extracted or with adjacent teeth
- •Current smokers (>10 cigarettes per day)
- •Uncontrolled diabetes mellitus (HbA1c >7.0)
- •Any active oral or systemic acute infections
- •Currently receiving chemo- or radiotherapy or a history of radiotherapy in the head and neck area
- •Diseases or medications that may compromise normal wound healing
结局指标
主要结局
Percentage of vital bone via histomorphometric evaluation of bone core biopsies at 3 months
时间窗: 3 months
Percentage of vital bone
Percentage of vital bone via histomorphometric evaluation of bone core biopsies at 6 months
时间窗: 6 months
Percentage of vital bone
次要结局
- Linear dimensional alterations of the alveolar ridge from the time of tooth extraction to the time of implant placement (3 months)(3 months)
- Patient reported outcomes (number of days of total or partially impaired activity) following implant placement(4 months post implant placement)
- Linear dimensional alterations of the alveolar ridge from the time of tooth extraction to the time of implant placement (6 months)(6 months)
- Assessment of the mucosal healing of the extraction sites at 2 weeks using a wound healing index (1-3 scale rating)(2 weeks following tooth extraction and alveolar ridge preservation)
- Assessment of the mucosal healing after implant placement at 2 weeks using a wound healing index (1-3 scale rating)(2 weeks after dental implant placement)
- Patient reported outcomes (number of days of total or partially impaired activity) following tooth extraction(At the time of implant placement (3 or 6 months))
- Patient reported outcomes (pain) 2 weeks following tooth extraction, using a Visual Analog Score for pain (0-100)(2 weeks following tooth extraction and alveolar ridge preservation)
- Patient reported outcomes (patient satisfaction), using a Visual Analog Scale (0-100)(Up to 30 days post implant crown delivery)
- Patient reported outcomes (pain) 3 months following tooth extraction, using a Visual Analog Score for pain (0-100)(3 months following tooth extraction and alveolar ridge preservation)
- Patient reported outcomes (pain) 6 months following tooth extraction, using a Visual Analog Score for pain (0-100)(6 months following tooth extraction and alveolar ridge preservation)
- Implant survival rate(1 year post implant loading)
- Marginal bone level changes(1 year post implant loading)