Gingiva
Conditions
Interventions
Sponsors
São Leopoldo Mandic
Rehabilitare
Eligibility
Inclusion criteria
Inclusion criteria: Healthy subjects requiring bilateral gingival graft for corrections of mucogingival or peri-implant deformities; non smokers; both genders.
Exclusion criteria
Exclusion criteria: Systemic conditions that contraindicate the procedure; use of drugs that can alter the healing potential of the tissues; smokers; pregnant or lactating women; immunocompromised patients; conditions requiring prophylactic antibiotic therapy; previous palate surgery less than six months; any palate abnormality that makes surgery contraindicated.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expected outcome: The primary outcome of the study was the patients' pain perception. Postoperative pain intensity perceived by patients in donor areas was assessed for 30 days using a visual analog scale (VAS) in which the patient answered the following question: “How severe is your pain at the place where the graft was removed?”. Each VAS was 100 mm in length, in which the beginning indicated “no pain” and the end “unbearable pain”. Postoperative pain intensity was assessed every 8 hours (i.e., 8:00 AM, 4:00 PM, and 12:00 AM) on the first day after surgery and every 12 hours (i.e., 8:00 AM and 8:00 PM) on the following 29 days, corresponding to a 720-hour follow up. ;Outcome found: All the recruited subjects completed the study. In both groups, there was a statistically significant reduction in postoperative pain intensity (VAS scores) over time. Intragroup analysis also demonstrated statistically significant reduction from the 14th day after surgery on the control group and from the 17th day for the test group. There were no statistical differences in VAS scores between groups in any time point. | — |
Secondary
| Measure | Time frame |
|---|---|
| Expected outcome: Secondary outcome included the assessment of the healing in both donor areas with intraoral photographs that were taken immediately after the surgery and after 7, 14, 21, 28, 35, 42, 49 and 56 days. The photographs were evaluated by 3 masked periodontists. For each day and subject, the examiners received the photos and a questionnaire form including 2 questions: (a) Which side exhibits the best healing based on color, morphology, and texture? The answer had 3 alternatives: 1-right side, 2-left side, 3- similar healing. (b) Which side is fully epithelialized? This question had 4 possible answers: 1-right side, 2-left side, 3- both sides, 4- none.;Outcome found: Photograph analysis demonstrated that out of the 8 time points evaluated by the three examiners (total 24), 12 time points revealed, subjectively, a tendency towards better healing for the test side, 3 time points for the control side and 9 were considered similar when the morphology, texture and color were observed. No clinical differences were found when the examiners were asked about when the fully epithelialization occurred. | — |
Countries
Brazil
Contacts
Public ContactCarla Carrinho
Faculdade São Leopoldo Mandic
Outcome results
None listed