A Three-arm Randomized Controlled Trial Comparing Transmucosal Augmentation Techniques in Immediate Implant Placement
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Succesful regeneration (%)
研究概览
简要总结
Patients undergoing single immediate implant placement (IIP) in the premaxilla will be invited to participate in this randomized controlled trial (RCT). Prior to surgery, a small- field low-dose cone beam computed tomography (CBCT) is taken to verify the integrity of the facial bone wall and an adequate amount of apical and palatal bone availability for implant anchorage. 54 patients will be randomly assigned to either conventional connective tissue graft (C-CTG), scarf tissue graft (S-CTG) or dual zonde conept (DZ). Sealed envelopes are prepared for that purpose, of which 18 are internally labeled as C-CTG, 18 as S-CTG and 18 as DZ. Following IIP, a sealed envelope will be opened to reveal the treatment concept.
Successful regeneration (primary outcome) is achieved when the combination of socket grafting and transmucosal augmentation (C-CTG or S-CTG or DZ) would be able to counteract any buccal soft tissue loss at level -1 mm. It is assessed on the basis of superimposed CBCTs taken pre-operatively and at one-year follow-up. Secondary outcomes include: horizontal buccal bone loss, vertical buccal bone loss, increase in buccal soft tissue thickness, patient-reported outcomes, plaque, bleeding on probing, probing depth, marginal bone loss, change in buccal soft tissue profile, midfacial soft tissue level, mesial and distal papilla level, Pink Esthetic Score.
详细描述
This study is a three-arm randomized controlled trial comparing conventional connective tissue grafting (C-CTG) with two alternative soft-tissue augmentation approaches-scarf CTG (S-CTG) and the dual-zone technique (DZ)-in patients receiving single immediate implant placement in the anterior maxilla. The primary objective is to determine which method results in the highest proportion of sites showing successful regeneration 1 mm below the implant shoulder. Secondary outcomes assess clinical parameters, patient-reported pain and medication use, hard- and soft-tissue dimensional changes, and esthetic scores.
Eligible participants are adults with good oral hygiene and an anterior maxillary tooth requiring extraction with adequate bone support. Exclusion criteria include pregnancy, systemic disease, smoking, active infection, periodontal disease, and extensive gingival asymmetry. Fifty-four patients will be randomized equally to the three intervention groups; allocation is concealed and outcome assessors are blinded.
All patients receive immediate implant placement with socket grafting. The three groups differ only in the soft-tissue augmentation method: C-CTG involves placing a connective tissue graft in a buccal pouch; S-CTG uses a smaller graft fixed at the transmucosal aspect without a pouch; DZ relies on graft condensation beneath the soft tissue without a connective tissue graft. Standard postoperative care is provided in all groups.
Hard- and soft-tissue changes are assessed using cone-beam CT, clinical measurements, intra-oral scans, and standardized photography at baseline and follow-up visits. Successful regeneration is defined by maintenance of buccal soft tissue at the specified reference level. Patient-reported postoperative pain and analgesic use are recorded after one week. Esthetic outcomes are evaluated using a validated scoring system at 1- and 5-year follow-up.
Data will be analyzed using appropriate statistical tests for group comparisons, including mixed models for tissue changes, Fisher's exact test for the primary outcome, and non-parametric tests for variables that are not normally distributed. A two-sided significance level of 5% is applied throughout.
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
As this RCT concerns a surgical intervention, patients and treating clinicians can not be masked.
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •At least 20 years old
- •Good oral hygiene defined as full-mouth plaque score ≤ 25%
- •Presence of an incisor, cuspid or premolar in the maxilla that needs to be extracted for any reason with at least one neighboring tooth present
- •At least 3 mm bone available at the apical or palatal aspect of the alveolus as assessed on CBCT to ensure primary implant stability
- •Intact buccal bone wall (type I) or limited buccal bone dehiscence (type IIa or IIb) at the time of extraction
- •Written informed consent.
排除标准
- •Pregnancy
- •Systemic diseases
- •Smoking; suppuration
- •> 1 mm gingival asymmetry between the failing and contralateral tooth
- •Untreated periodontal disease
- •Untreated caries lesions.
研究组 & 干预措施
Conventional connective tissue graft
Connective tissue graft immediately inserted in buccal pouch
干预措施: Conventional connective tissue graft after immediate implant placement (Procedure)
Scarf connective tissue graft
Connective tissue graft immediately fixed onto the buccal mucosa.
干预措施: Scarf connective tissue graft after immediate implant placement (Procedure)
Dual zone concept
Bone material condensed up to the buccal soft tissue margin.
干预措施: Dual zone concept after immediate implant placement (Procedure)
结局指标
主要结局
Succesful regeneration (%)
时间窗: 1-, 5 year
Successful regeneration is achieved when the combination of socket grafting and transmucosal augmentation (C-CTG or S-CTG or DZ) would be able to counteract any buccal soft tissue loss at level -1 mm. It is assessed on the basis of superimposed CBCTs taken pre-operatively and at one-year follow-up.
次要结局
- Horizontal buccal bone loss -1, -3 and -5 (mm)(1-, 5 year)
- Vertical bone loss (mm)(1-, 5 year)
- Increase in buccal soft tissue thickness (mm)(1-, 5 year)
- Patient-reported outcomes(1-, 5 year)
- Plaque (%)(1-, 5 year)
- Bleeding on probing (%)(1-, 5 year)
- Probing depth (mm)(1-, 5 year)
- Marginal bone loss (mm)(1-, 5 year)
- Change in buccal soft tissue profile (mm)(1-, 5 year)
- Change in midfacial soft tissue level (mm)(1-, 5 year)
- Change in mesial and distal papilla level (mm)(1-, 5 year)
- Pink Esthetic Score(1-, 5 year)