Mucogingival DefectsPontic SiteNCT07535060
Pontic Site Development With or Without Fixed Partial Denture
A study testing Connective Tissue Graft (CTG) in people with Mucogingival Defects and Pontic Site Development, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mucogingival Defects, Pontic Site Development, Keratinized Tissue Deficiency
- What is being tested?
- Connective Tissue Graft (CTG)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 6 Oct 2025to 1 Jun 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Smokers.
- Pregnancy and lactation
- Periodontitis
- Severe gagging reflex
- Handicapped and mentally challenged patients
- Active soft tissue infection
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Dentistry, Cairo University
Cairo, 12613
Faculty of Dentistry Cairo University, 010 02159535, dentmail@dentistry.cu.edu.eg
Ahmed Mohamed Elatreby, BDS
About this study
Official 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.
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.
Read more
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.
Read the 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.
- Conditions
- Mucogingival Defects, Pontic Site Development, Keratinized Tissue Deficiency, Connective Tissue Graft
- Being tested
- Connective Tissue Graft (CTG)
- 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Connective Tissue Graft (CTG)Procedure or surgery
Also called Subepithelial Connective Tissue Graft, Soft Tissue Augmentation
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Connective Tissue Graft (CTG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Keratinized Tissue Thickness
Measured in millimeters using transgingival probing
Measured: Baseline and 6 months
Secondary outcomes (7)
Keratinized Tissue Width
Measured in millimeters using periodontal probe
Measured: Baseline and 6 month
Volumetric contour changes
Assessed using digital intraoral scanning and 3D analysis
Measured: Baseline, 3 months, and 6 months
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.
Measured: 6 months
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
Measured: 6 months
Post-operative pain
Measured using Visual Analogue Scale (VAS) ranging from 0 (no pain) to 10 (worst pain)
Measured: Day 3, day 7, and day 14
Patient satisfaction
Assessed using quality-of-life questionnaire
Measured: 6 months
Plaque Index
Assessed using plaque index ranging from 0 (no plaque) to 3 (abundant plaque)
Measured: Baseline and 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2026
- Study start6 Oct 2025
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mucogingival DefectsStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Hassan Elatreby, Cairo University
- Investigators
- Enji Ahmed Mahmoud, PHD holder, Study director, Professor of Oral Medicine and Periodontology - Faculty of Dentistry, Cairo University.Omnia Khaled Tawfik, PHD Holder, Study director, Lecturer of Oral Medicine and Periodontology- Cairo University.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07535060
- Sponsor's protocol ID
- PER 3-3-1
- Acronym
- Pontic Site
- Status last verified
- Apr 2026
- First submitted
- 6 Apr 2026
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No