Comparing two techniques for treating ridge contour defects in the mouth
Evaluation of a Novel Technique Versus Conventional Subepithelial Connective Tissue Graft in Treatment of Ridge Contour Defects. A Randomized Controlled Clinical Trial
NA · Misr International University · NCT06435780
This study is testing a new method for fixing soft tissue defects in the mouth to see if it works better than the traditional graft technique for patients with ridge contour issues.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | All |
| Sponsor | Misr International University (other) |
| Locations | 1 site (Cairo) |
| Trial ID | NCT06435780 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate and compare the effectiveness of a novel Denuded interpositional pedicled rolled flap technique (DIPRF) against the conventional subepithelial connective tissue graft technique for augmenting soft tissues in patients with ridge contour defects. Fifty patients with soft tissue defects in the maxillary premolar region will be randomly assigned to either the test group receiving DIPRF or the control group receiving the conventional graft. Clinical and radiographic assessments will be conducted to measure tissue volumetric changes and ridge thickness at various intervals post-surgery, alongside patient-reported outcomes regarding pain and satisfaction. The study will utilize advanced imaging techniques, including digitally calibrated casts and CBCT analysis, to ensure accurate evaluations.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 50 with specific soft tissue ridge contour defects in the maxillary premolar region and good oral hygiene.
Not a fit: Patients with ridge defects due to bone issues, smokers exceeding 10 cigarettes per day, or pregnant females may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective method for soft tissue augmentation, improving outcomes for patients requiring dental implants or fixed restorations.
How similar studies have performed: While this approach is innovative, similar studies have shown varying degrees of success with soft tissue grafting techniques.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Adults above the age of 18 to 50 years. 2. Males and females as confirmed by asking the female patients about whether they are pregnant or not 3. Patient's with Seibert classification class I requiring future rehabilitation of one or more premolar region and sound adjacent teeth. 4. Soft tissue thickness on the palatal tissues more than 6mm at the site of harvesting the graft. 5. Presence of Mandibular posterior teeth opposing the tooth to be replaced for occlusion. 6. Clinically healthy soft tissues with no signs of clinical pathology of the soft tissue. 7. Good oral hygiene. 8. Patient accepts to sign an informed consent. 9. ASA I or ASA II Patient. Exclusion Criteria: 1. Patients with ridge defects due to bone defect 2. Smoker patients who smoke more than 10 cigarettes per day 3. Pregnant females
Where this trial is running
Cairo
- Misr International University — Cairo, Egypt (RECRUITING)
Study contacts
- Principal investigator: Hebattallah A Mattar — Misr International University
- Study coordinator: Hebattallah A Mattar
- Email: hebatullah.mater@miuegypt.edu.eg
- Phone: 201207000253
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.
Conditions: Defect in Alveolar Ridge, ridge contour defect, soft tissue graft, Rolling Technique, Connective tissue graft, Subepithelial palatal graft, Seibert Class I