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NCT Number: NCT07535060

Pontic Site Development With or Without Fixed Partial Denture

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Cairo University

Cairo, 12613, Egypt

Location status: Recruiting

Location contact

Ahmed Mohamed Elatreby, BDS

PRINCIPAL_INVESTIGATOR

Faculty of Dentistry Cairo University

CONTACT

[email protected]

010 02159535

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Subepithelial Connective Tissue Graft, Soft Tissue Augmentation

Primary outcomes

  1. Keratinized Tissue Thickness

    Time frame: Baseline and 6 months

    Measured in millimeters using transgingival probing

Secondary outcomes

  1. Keratinized Tissue Width

    Time frame: Baseline and 6 month

    Measured in millimeters using periodontal probe

  2. Volumetric contour changes

    Time frame: Baseline, 3 months, and 6 months

    Assessed using digital intraoral scanning and 3D analysis

  3. Pink Esthetic Score (PES)

    Time frame: 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.

  4. Blinded assessment for esthetics

    Time frame: 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

  5. Post-operative pain

    Time frame: Day 3, day 7, and day 14

    Measured using Visual Analogue Scale (VAS) ranging from 0 (no pain) to 10 (worst pain)

  6. Patient satisfaction

    Time frame: 6 months

    Assessed using quality-of-life questionnaire

  7. Plaque Index

    Time frame: Baseline and 6 Months

    Assessed using plaque index ranging from 0 (no plaque) to 3 (abundant plaque)

Study contacts

Contact information is provided by the study sponsor or research team.

Ahmed Mohamed Elatreby, BDs

CONTACT

[email protected]

01004177718 ext. +2

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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.

Acronym: Pontic Site

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Apr 16, 2026
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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