Gum tissue build-up at a missing-tooth pontic site with or without a 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.
We will test whether connective tissue grafts can improve gum thickness and contour at a single missing-tooth site in adults, comparing sites that have an existing fixed partial denture to sites without one.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Cairo University Academic / other |
| Locations | 1 site (Cairo) |
| Trial ID | NCT07535060 on ClinicalTrials.gov |
What this trial studies
This non-randomized, parallel clinical trial at Cairo University will compare connective tissue grafting (CTG) outcomes at single edentulous pontic sites with an existing fixed partial denture (FDP) versus sites without an FDP. Adults with a single missing tooth in the esthetic zone will receive CTG using a standardized surgical technique after initial periodontal preparation. The primary outcome is keratinized tissue thickness measured clinically, and secondary outcomes include keratinized tissue width, volumetric soft tissue changes, Pink Esthetic Score, plaque index, postoperative pain, and patient satisfaction using clinical and digital assessments. The presence or absence of the prosthesis is the main comparison while all other surgical and follow-up procedures are kept consistent across groups.
Who should consider this trial
Good fit: Adults (≥18 years) who have a single missing tooth in the esthetic zone (2nd premolar to 2nd premolar) that has been missing at least three months, are systemically healthy, have at least 2 mm of keratinized tissue on adjacent teeth, and can provide informed consent are ideal candidates.
Not a fit: Patients who smoke, have active periodontitis or soft tissue infection, are pregnant or lactating, have a severe gag reflex, or are otherwise unable to tolerate surgery or follow-up are unlikely to benefit from joining this protocol.
Why it matters
Potential benefit: If successful, patients may be able to keep an existing fixed partial denture while still achieving improved gum thickness, contour, and esthetic outcomes after connective tissue grafting.
How similar studies have performed: Connective tissue grafting is an established method with many studies showing improved tissue thickness and esthetics, but few trials have specifically tested outcomes when the augmentation is performed without removing an existing fixed partial denture.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Cairo
- Faculty of Dentistry, Cairo University — Cairo, Egypt (Recruiting)
Study contacts
- Study coordinator: Ahmed Mohamed Elatreby, BDs
- Email: ahmed.elatreby@dentistry.cu.edu.eg
- Phone: 01004177718
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.