NCT07535060 Pontic Site Development With or Without Fixed Partial Denture
| NCT ID | NCT07535060 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Cairo University |
| Condition | Mucogingival Defects |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-10-06 |
| Primary Completion | 2027-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2025-10-06 with a primary completion date of 2027-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Enji Ahmed Mahmoud, PHD holder
STUDY DIRECTOR
Professor of Oral Medicine and Periodontology - Faculty of Dentistry, Cairo University.
Frequently Asked Questions
Who can join the NCT07535060 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Mucogingival Defects. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07535060 currently recruiting?
Yes, NCT07535060 is actively recruiting participants. Contact the research team at ahmed.elatreby@dentistry.cu.edu.eg for enrollment information.
Where is the NCT07535060 trial being conducted?
This trial is being conducted at Cairo, Egypt.
Who is sponsoring the NCT07535060 clinical trial?
NCT07535060 is sponsored by Cairo University. The principal investigator is Enji Ahmed Mahmoud, PHD holder at Professor of Oral Medicine and Periodontology - Faculty of Dentistry, Cairo University.. The trial plans to enroll 20 participants.