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Pontic Site Development With or Without Fixed Partial Denture

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.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07535060
Acronym
Pontic Site
Enrollment
20
Registered
2026-04-16
Start date
2025-10-06
Completion date
2027-06-01
Last updated
2026-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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

Cairo University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

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

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

MeasureTime frameDescription
Keratinized Tissue ThicknessBaseline and 6 monthsMeasured in millimeters using transgingival probing

Secondary

MeasureTime frameDescription
Keratinized Tissue WidthBaseline and 6 monthMeasured in millimeters using periodontal probe
Volumetric contour changesBaseline, 3 months, and 6 monthsAssessed using digital intraoral scanning and 3D analysis
Pink Esthetic Score (PES)6 monthsIt 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 esthetics6 monthsCalibration 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 painDay 3, day 7, and day 14Measured using Visual Analogue Scale (VAS) ranging from 0 (no pain) to 10 (worst pain)
Patient satisfaction6 monthsAssessed using quality-of-life questionnaire
Plaque IndexBaseline and 6 MonthsAssessed using plaque index ranging from 0 (no plaque) to 3 (abundant plaque)

Countries

Egypt

Contacts

CONTACTAhmed Mohamed Elatreby, BDs
ahmed.elatreby@dentistry.cu.edu.eg01004177718
STUDY_DIRECTOREnji Ahmed Mahmoud, PHD holder

Professor of Oral Medicine and Periodontology - Faculty of Dentistry, Cairo University.

STUDY_DIRECTOROmnia Khaled Tawfik, PHD Holder

Lecturer of Oral Medicine and Periodontology- Cairo University.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 2, 2026