Gum recession treatment with two different approaches

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Catégorie Primary study
Registry of TrialsISRCTN registry
Year 2021
INTERVENTION: The test group will be treated with apical buccal access approach and connective tissue graft Control group will be treated with tunnel approach and connective tissue graft The intervention will we realized in a single session and the follow‐up will be 12 months after the surgical procedure. Randomization will be carried out by means of 5 blocks by a sequence generated by the computer. Randomization: The randomization will be carried out prior to the procedure by the statistician (EGT) but without the operator (AOV) knowing the technique that he will have to use until the moment of the first incision. Assignment to the test or control group is done using a block‐based computer algorithm after the inclusion of the patient and prior to the surgical intervention. The randomization treatment assignment is disclosed at the time of the surgical procedure. Each patient included in the study has the same probabilities as the others of being assigned to the test or control group. Surgical procedure: On day 0 the first surgical procedure will be performed, which will include the following phases: The stopwatch is activated to measure the intervention time Local anesthesia Depending on the randomization: incision to the bottom of the vestibule in a semilunar shape / preparation of the beds that will receive the graft by tunneling and connecting all the recessions through the tunnel without making incisions Elevation of a full thickness flap to create a vascular bed for the graft anesthetize the posterior palatal area (distal to the premolars) and take a graft that is the length and width CONDITION: Miller Class III multiple gingival recessions ; Oral Health PRIMARY OUTCOME: Recession reduction measured by a manual periodontal probe and intraoral scanning at baseline, 6 months and 12 month INCLUSION CRITERIA: 1. Informed consent after detailed information 2. Adults at least 18 years of age 3. Patients with multiple recessions (=2 teeth) class III Miller with shallow vestibulum depth and keratinized mucosa 4. Non‐molar teeth 5. Upper and lower jaw 6. Healthy or periodontally treated patients 7. Systematically healthy or with fully controlled or stabilized diseases 8. A medical report will be requested to confirm the stabilization of the specific disease 9. General plaque control (FMPS) =25% SECONDARY OUTCOME: ; 1. Complete root coverage measured by a manual periodontal probe and intraoral scanning at baseline, 6 months and 12 months; 2. Increased vestibule depth measured by a manual periodontal probe and intraoral scanning at baseline, 6 months and 12 months; 3. Keratinized gum augmentation measured by a manual periodontal probe and intraoral scanning at baseline, 6 months and 12 months; 4. Volume increase measured by a manual periodontal probe and intraoral scanning at baseline, 6 months and 12 months; 5. Time spent on both types of procedures measured in minutes intrasurgically; 6. Patient satisfaction with the treatment received and its relationship with pre‐surgical expectations measured by a Visual Analogue Scale at baseline, 2weeks, 4weeks, 12weeks, 6months and 12 months; 7. Analgesia intake measured taking into account the number of analgesic pills consumption by patient self‐report at baseline, 6 months and 12 months; 8. Aesthetic satisfaction by the clinical examiner measured by a blinded examiner at 6 and 12 months in order to evaluate the visual satisfaction with obtained outcome;
Epistemonikos ID: db9b1f9f71df09332a13982d80e98ee93ccf23a9
First added on: Aug 24, 2024