Guided Bone Regeneration in Alveolar Socket Using a Synthetic Resorbable Membrane. a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- Osseous changes in height of the alveolar ridge
研究概览
简要总结
Following tooth extraction, volumetric changes in the soft and hard tissues of the extraction site are expected to occur with considerable resorption of the alveolar bone in both the vertical and the horizontal dimensions. These changes may complicate surgical implant placement and may also compromise the outcome of the prosthetic reconstruction. Various treatment approaches have been introduced aiming to preserve the dimensions of the alveolar ridge at the extraction site and facilitate optimal implant placement.
This prospective randomized controlled trial aims to determine the efficacy of alveolar ridge preservation utilizing two different socket seal approaches compared to spontaneous healing to stabilize the blood clot within the postextraction socket. Thirty-six subjects will be randomly allocated into one of the three treatment groups. Group-A: Extraction of the tooth and suturing of the extraction socket with resorbable suture PGA 5/0. Group-B: Extraction of the tooth and placement of a Free Gingival Graft stabilized with resorbable suture PGA 5/0. Group-C: Extraction of the tooth and placement of the Polylactic-Glycolic Acid membrane stabilized with resorbable suture PGA 5/0. After the initial examination for screening, subjects will be assessed at baseline-extraction day- and after 1, 2, and 6 weeks, and 3 months. The changes of the alveolar crest will be determined in height and width, in addition to volumetric changes in the soft tissues, and the width of keratinized tissues. The wound healing process will be visually assessed.
详细描述
This prospective randomized controlled trial aims to determine the effectiveness of two different approaches of the "socket seal technique" for the preservation of the soft and hard tissues at the extraction site by utilizing a free gingival graft (FGG) or a PLGA membrane to stabilize the blood clot within the extraction socket compared with spontaneous healing of the tissues.
Primary outcome variable of the study will be alveolar bone changes in height buccally and palatally.
Secondary outcome variables: Alveolar bone changes in width, Mucosa thickness changes, Wound healing visual assessment, Width of keratinized tissues.
Materials and methods Thirty-six subjects will be randomly allocated into one of the three treatment groups based on computer-generated lists using a "block-design". Each patient contributes with one study site.
Study groups:
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 (Investigator, Outcomes Assessor)
盲法说明
Treatment is disclosed to the examiner after all data have been collected; investigator and care provider are different individuals.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Referrals for a single tooth extraction
- •Periodontal destruction less than 50% of tooth support
- •Signed inform consent form
排除标准
- •Systematic diseases, contradicting surgical procedures and compromise wound healing (i.e. uncontrolled diabetes)
- •Medication that interferes with bone metabolism
- •Pregnancy or lactation
- •Multiple extractions
- •Absence of adjacent teeth
- •Loss of buccal bone, either due to periodontal disease or because of traumatic extraction
结局指标
主要结局
Osseous changes in height of the alveolar ridge
时间窗: Clinically: immediately after tooth extraction(baseline), 6 weeks and 3 months after the extraction. CBCT: immediately after the extraction and 3 months after the extraction
The height of the alveolar ridge will be measured at standardized points distal, mesial and buccal/ palatal/ lingual at standardized points with the use of a reference stent by a CBCT.
Osseous changes in width of the alveolar ridge
时间窗: Immediately after the extraction(baseline) and 3 months after the extraction
The width of the alveolar ridge will be measured distal, mesial and buccal/ palatal/ lingual at standardized points with the use of a reference stent by a CBCT.
次要结局
- Wound healing(1 and 2 weeks after the extraction)
- Width of keratinized tissues(Baseline, 6 weeks and 3 months after the extraction)
- Mucosa thickness changes(Baseline, 6 weeks and 3 months after the extraction)
研究者
Danae A. Apatzidou
Associate Professor
Aristotle University Of Thessaloniki