A Randomized Controlled Trial Comparing Guided Bone Regeneration With Connective Tissue Graft to Re-establish Buccal Convexity at Implant Sites: Three-year Results.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 主要终点
- Buccal soft tissue profile
研究概览
简要总结
The most frequent aesthetic complication following single implant treatment seems to be a lack of buccal convexity. This 'alveolar process deficiency' is the result of buccal bone remodeling following tooth extraction.
A traditional approach to treat alveolar process deficiency is guided bone regeneration (GBR), however post-operative complications such as swelling, bleeding and pain are common and the aesthetic outcome may not be optimal.
An alternative to the traditional GBR approach could be soft tissue contour augmentation using a connective tissue graft (CTG) at the buccal aspect. Possible advantages over GBR include less morbidity at the implant site, a superior aesthetic outcome since there is no need for vertical releasing incisions and less costs since there are no biomaterials to be used.
The primary study objective is to compare the GBR and CTG group in terms of 2 and 3 dimensional tissue alterations, focusing on the amount of tissue gain and volume stability over time. The secondary study objectives are morbidity, overall radiographic, clinical and aesthetic outcomes.
详细描述
Aim:
This study aims to compare guided bone regeneration (GBR) with connective tissue graft (CTG) to re-establish buccal convexity at single implants.
Sample size calculation:
The sample size calculation was based on the primary study outcome (BSP) and was performed in SAS Power using the Satterthwaite t-test (De Bruyckere et al., 2018). The calculation was based on finding a mean difference of at least 0.5 mm between these groups with a standard deviation of 0.5 mm. This standard deviation was arbitrarily chosen given the lack of comparative studies. Alpha was set at 0.05 and the power was set at 0.80. This resulted in the inclusion of at least 17 patients per group. To compensate for possible drop-outs, 21 patients were included in each group.
Randomization and allocation concealment:
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
Patients will be randomly assigned to the control group (GBR) or test group (CTG). Simple randomization was performed using sealed envelopes with an equal number of envelopes for every treatment group. Group allocation was revealed just prior to surgery by the surgeon.
The measuring clinician will not be involved in the treatment of any of the patients and will be blinded to allow unbiased registrations.
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
- •At least 18 years old.
- •Good oral hygiene defined as full-mouth plaque score ≤ 25% (O'Leary et al.1972
- •Presence of a single tooth gap in the anterior maxilla (15 - 25) with both neighbouring teeth present
- •Failing tooth at least 3 months earlier removed
- •Class I defect at the single tooth gap as clinically assessed (buccopalatal loss of tissue with a normal apicocoronal ridge height) (Seibert, 1983)
- •Signed informed consent
- •Buccopalatal bone dimension of at least 6 mm at the central and crestal aspect of the single tooth gap to ensure complete embedding of an implant by bone
排除标准
- •Systemic diseases
- •(History of) periodontal disease
- •Untreated caries lesions
- •Need for horizontal bone augmentation at the time of implant placement
结局指标
主要结局
Buccal soft tissue profile
时间窗: Year 1 and 3
The volumetric analysis software (Swissmeda/SMOP, Zürich, Switzerland) calculated a mean dimensional change (mm3) within the AOI (area of interest) for each patient at T5 (3 years). Given the variable size in AOI (mm2) among patients, the mean dimensional change per area was transformed to a mean linear change in buccal soft tissue profile (BSP) in mm.
次要结局
- Probing depth(Year 1 and 3)
- Plaque(Year 1 and 3)
- Buccal bone thickness(Year 1 and 3)
- Pink Esthetic Score(Year 1 and 3)
- Midfacial recession(Month 6; Year 1 and 3)
- Buccal soft tissue thickness(Year 1 and 3)
- Mucosal Scarring Index(Year 1 and 3)
- Bleeding on probing(Year 1 and 3)
- Marginal bone loss(Year 1 and 3)