Mucogingival Defects, Pontic Site Development, Keratinized Tissue Deficiency, Connective Tissue Graft
Conditions
Keywords
Connective Tissue Graft (CTG), Soft Tissue Augmentation, Pontic Site Development, Alveolar Ridge Defects, Fixed Partial Denture (FDP), Ridge Augmentation, Periodontal Plastic Surgery, Keratinized Tissue Thickness, Keratinized Tissue Width, Esthetic Outcome, Pink Esthetic Score (PES), Volumetric Soft Tissue Analysis, Dental Prosthetics, Edentulous Ridge, Non-Randomized Clinical Trial
Brief summary
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.
Detailed description
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. Follow-up assessments will be conducted over a 6-month period to evaluate healing, tissue stability, and overall clinical performance. The significance of this study lies in its potential to support a less invasive treatment approach by eliminating the need for prosthesis removal, which may reduce treatment time, cost, and patient discomfort while maintaining satisfactory clinical and esthetic outcomes.
Interventions
Soft tissue augmentation will be performed using a subepithelial connective tissue graft (CTG) harvested from the palate and placed at the pontic site using a minimally invasive pouch/tunnel technique. The procedure aims to increase soft tissue thickness and improve contour in edentulous ridge defects. The same surgical protocol will be applied in all participants, with variation based only on the presence or absence of an existing fixed partial denture.
Sponsors
Study design
Masking description
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.
Intervention model description
This study follows a parallel-group, non-randomized interventional model in which participants are allocated into two groups based on the presence or absence of an existing fixed partial denture (FDP) at the pontic site. Both groups will receive the same surgical intervention using a standardized connective tissue graft (CTG) technique. The allocation is based on clinical presentation rather than randomization, reflecting real-world treatment conditions. The study is designed under a superiority framework to evaluate whether CTG performed around an existing FDP can achieve comparable or improved clinical and volumetric outcomes relative to sites without an FDP.
Eligibility
Inclusion criteria
* 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
Exclusion criteria
* Smokers. * Pregnancy and lactation * Periodontitis * Severe gagging reflex * Handicapped and mentally challenged patients * Active soft tissue infection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Keratinized Tissue Thickness | Baseline and 6 months | Measured in millimeters using transgingival probing |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Keratinized Tissue Width | Baseline and 6 month | Measured in millimeters using periodontal probe |
| Volumetric contour changes | Baseline, 3 months, and 6 months | Assessed using digital intraoral scanning and 3D analysis |
| Pink Esthetic Score (PES) | 6 months | It consists of seven variables, each scored 0-1-2 (with 2 being best), for a maximum score of 14, assessing papillae, tissue level, contour, color, texture, and alveolar process. |
| Blinded assessment for esthetics | 6 months | Calibration of the Assessors: Before initiating clinical measurements, 3 assessors will undergo calibration to ensure reliability and reduce intra-examiner variability. The calibration will aim for a kappa (κ) value greater than 0.75 to confirm consistency. The assessors will be trained to score according to the PES Blinding of the Assessors: The assessors will be masked and remain unaware of treatment group assignments. Assessors will not be any part of the ttt process |
| Post-operative pain | Day 3, day 7, and day 14 | Measured using Visual Analogue Scale (VAS) ranging from 0 (no pain) to 10 (worst pain) |
| Patient satisfaction | 6 months | Assessed using quality-of-life questionnaire |
| Plaque Index | Baseline and 6 Months | Assessed using plaque index ranging from 0 (no plaque) to 3 (abundant plaque) |
Countries
Egypt
Contacts
Professor of Oral Medicine and Periodontology - Faculty of Dentistry, Cairo University.
Lecturer of Oral Medicine and Periodontology- Cairo University.