Pontic Site Development With or Without Fixed Partial Denture

NCT07535060 | Recruiting DMC

• 1 other identifier: PER 3-3-1
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Mucogingival Defects; Pontic Site Development; Keratinized Tissue Deficiency; Connective Tissue Graft

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

Outcome Measures

Primary Outcomes (1)

• Keratinized Tissue Thickness

  Measured in millimeters using transgingival probing

  Baseline and 6 months

Secondary Outcomes (7)

• Keratinized Tissue Width

  Baseline and 6 month

• Volumetric contour changes

  Baseline, 3 months, and 6 months

• Pink Esthetic Score (PES)

  6 months

• Blinded assessment for esthetics

  6 months

• Post-operative pain

  Day 3, day 7, and day 14

Study Arms (2)

CTG with Existing Fixed Partial Denture

EXPERIMENTAL

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.

Procedure: Connective Tissue Graft (CTG)

CTG without Fixed Partial Denture

EXPERIMENTAL

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.

Procedure: Connective Tissue Graft (CTG)

Interventions

Connective Tissue Graft (CTG) PROCEDURE

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.

Also known as: Subepithelial Connective Tissue Graft, Soft Tissue Augmentation

CTG with Existing Fixed Partial Denture; CTG without Fixed Partial Denture

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Smokers.
• Pregnancy and lactation
• Periodontitis
• Severe gagging reflex
• Handicapped and mentally challenged patients
• Active soft tissue infection

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Dentistry, Cairo University

Cairo, 12613, Egypt

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Oral Medicine and Periodontology, Faculty of Dentistry, Cairo University

Model Details: 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.

Study Record Dates

• First Submitted: April 6, 2026
• First Posted: April 16, 2026
• Study Start: October 6, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: April 16, 2026

Record last verified: 2026-04

Locations

EG (1)