Clinical and Volumetric Evaluation of Soft Tissue Augmentation Using Connective Tissue Graft (CTG) in Pontic Site Defects With and Without Fixed Partial Dentures. A Non-randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Keratinized Tissue Thickness
研究概览
简要总结
This study aims to evaluate the effectiveness of soft tissue augmentation using connective tissue graft (CTG) in pontic site defects. It compares clinical and volumetric outcomes between sites with an existing fixed partial denture (FDP) and sites without an FDP.
Following tooth extraction, alveolar ridge resorption often leads to soft tissue defects that can compromise esthetics, function, and prosthetic outcomes. CTG is considered the gold standard for soft tissue augmentation due to its predictable improvement in tissue thickness and stability.
In this non-randomized clinical trial, patients with single edentulous sites in the esthetic zone will undergo CTG using a standardized surgical technique. The primary outcome is keratinized tissue thickness, while secondary outcomes include keratinized tissue width, volumetric soft tissue changes, esthetic evaluation (Pink Esthetic Score), plaque index, post-operative pain, and patient satisfaction.
Clinical and digital assessments will be conducted preoperatively and at follow-up intervals up to 6 months. The study aims to determine whether performing CTG around an existing bridge provides comparable or improved outcomes compared to sites without a bridge, potentially offering a less invasive alternative to prosthetic replacement.
详细描述
Alveolar ridge resorption following tooth extraction frequently results in soft tissue deficiencies that compromise esthetic outcomes, prosthetic design, phonetics, and oral hygiene. In pontic site defects, inadequate soft tissue volume may lead to poor emergence profile, food impaction, and patient dissatisfaction, especially in the esthetic zone.
Soft tissue augmentation using connective tissue graft (CTG) is widely recognized as a reliable technique for improving tissue thickness and contour. However, limited evidence exists regarding its effectiveness when performed around an existing fixed partial denture (FDP), where removal of the prosthesis is often considered necessary before augmentation.
This study aims to evaluate whether soft tissue augmentation can be successfully performed without removing an existing prosthesis, and whether outcomes are comparable to sites where no prosthesis is present.
A non-randomized, parallel clinical design will be used to compare two clinical scenarios: pontic sites associated with an existing FDP and pontic sites without an FDP. The same surgical approach will be applied in both conditions to ensure consistency, with the presence or absence of the prosthesis being the primary distinguishing factor.
All procedures will be carried out under standardized clinical conditions at the Faculty of Dentistry, Cairo University. Patients will undergo initial periodontal preparation prior to surgical intervention. The augmentation procedure will be performed using a connective tissue graft placed through a minimally invasive pouch technique to enhance soft tissue volume and contour.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Blinding will be limited to outcome assessors responsible for esthetic evaluation. These assessors will be independent and not involved in the surgical procedures or patient management. They will be masked to group allocation during evaluation to minimize assessment bias.
No other parties, including participants, care providers, or investigators, will be blinded due to the nature of the intervention and the non-randomized study design.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients will on missing tooth in the esthetic zone (2nd premolar to 2nd premolar), missing at least 3 months prior to recruitment, with or without FPD
- •Systemically free patient
- •≥18 years of age
- •Intact gingival tissue with at least 2mm keratinized tissue in adjacent teeth
- •Patients accept to provide informed consent
排除标准
- •Pregnancy and lactation
- •Periodontitis
- •Severe gagging reflex
- •Handicapped and mentally challenged patients
- •Active soft tissue infection
研究组 & 干预措施
CTG with Existing Fixed Partial Denture
Participants with pontic site defects associated with an existing fixed partial denture (FDP) will receive soft tissue augmentation using a connective tissue graft (CTG) without removal of the prosthesis.
干预措施: Connective Tissue Graft (CTG) (Procedure)
CTG without Fixed Partial Denture
Participants with pontic site defects without an existing fixed partial denture will receive soft tissue augmentation using a connective tissue graft (CTG). A temporary bridge will be provided during healing.
干预措施: Connective Tissue Graft (CTG) (Procedure)
结局指标
主要结局
Keratinized Tissue Thickness
时间窗: Baseline and 6 months
Measured in millimeters using transgingival probing
次要结局
- Keratinized Tissue Width(Baseline and 6 month)
- Volumetric contour changes(Baseline, 3 months, and 6 months)
- Blinded assessment for esthetics(6 months)
- Post-operative pain(Day 3, day 7, and day 14)
- Patient satisfaction(6 months)
- Pink Esthetic Score (PES)(6 months)
- Plaque Index(Baseline and 6 Months)
研究者
Ahmed Mohamed Hassan Elatreby
Master's student, Department of Oral Medicine and Periodontology, Faculty of Dentistry, Cairo University
Cairo University