Gingival Recession (RT1) Treatment With Different Gingival Augmentation Surgeries Compared With Untreated Contralateral Sites: A Randomized Controlled Clinical Study
| Registry | NCT05688293 |
|---|---|
| Status | Recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: double, treatment |
| Enrollment | 30 (Estimated) |
| Sponsor | Misr International University (Other) |
| Conditions | Gingival Recession |
| Interventions | Connective tissue graft, Free gingival graft, Non surgical (Procedure) |
| Dates | start 2025-02-05, primary completion 2027-01-20 (estimated), completion 2027-03-01 (estimated), first posted 2023-01-18, last updated 2026-07-06 |
| Locations | 1 site in Egypt |
Related Papers Related Patents Related Grants Related Experts
All trials for Gingival Recession All trials of Connective tissue graft All trials of Free gingival graft
Thin gingival phenotype is one of the major causative factors of gingival recession type 1 which can result in hypersensitivity, discomfort, and compromised esthetics. This study assess the efficacy of increasing the gingival thickness from thin gingival phenotype to thick gingival phenotype in the treatment of patients suffering from gingival recession (RT1) and maintenance of results using either connective tissue graft or de-epithelized free gingival graft after non-surgical periodontal debridement compared to non-surgical periodontal debridement alone.
This parallel arm randomized controlled clinical trial study will include systematically free patients with thin gingival phenotype. They will be randomly allocated to three equal groups. Group A (test group, n=10) will receive non-surgical periodontal treatment and connective tissue graft using tunneling technique, Group B (test group, n=10) will receive non-surgical periodontal treatment and partially de-epithelized free gingival graft, while group C (control group, n=10) will receive non-surgical periodontal treatment only. After 3, 6 and 12 months gingival biotype will be clinically assessed (1ry outcome). This parameter will be recorded at baseline, 3, 6 and 12 months. The 2ry outcomes will include recording of recession depth, plaque index, bleeding on probing, keratinized tissue width . Postoperative pain and swelling will be recorded daily by the patient for the 1st two weeks post-surgically. Postoperative instructions and medication will be given to the patient. All readings will be carried out by a calibrated outcome assessor who will be masked. Follow-up will be performed to assess the outcomes and to ensure performing proper oral hygiene. Data collected will be tabulated and statistically analyzed.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Connective tissue graft | Active comparator | Procedure: Connective tissue graft | Patients will receive non-surgical periodontal treatment and connective tissue graft using tunneling technique |
| Free gingival Graft | Active comparator | Procedure: Free gingival graft | Patients will receive non-surgical periodontal treatment and partially de-epithelized free gingival graft |
| Non surgical procedure | Active comparator | Procedure: Non surgical | Patients will receive non-surgical periodontal treatment only |
Sex: All, ages: 18 Years to 55 Years, accepts healthy volunteers
Inclusion Criteria: * Medically free patients (American Society of Anesthesiologists I; ASA I) * Patients diagnosed with recession (RT1) * Fair oral hygiene * Patient accepting to provides an informed consent and the follow-up Exclusion Criteria: * Carious teeth and teeth with periapical infection. * Patients diagnosed with periodontitis * Smokers * Pregnant and lactating females
| Facility | City | Country | Status |
|---|---|---|---|
| Faculty of oral and dental medicine, Misr international university | Cairo | Egypt | Recruiting |