About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Smokers.
Pregnancy and lactation
Periodontitis
Severe gagging reflex
Trial design
Parallel
Treatments tested in this trial
Connective Tissue Graft (CTG)
Procedure/SurgerySoft 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.
Treatment groups
Trial outcomes
Primary outcomes
Keratinized Tissue Thickness
Measured in millimeters using transgingival probing
Secondary outcomes
Keratinized Tissue Width
Measured in millimeters using periodontal probe
Volumetric contour changes
Assessed using digital intraoral scanning and 3D analysis
Pink Esthetic Score (PES)
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
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
Sponsors and contacts
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