Effect of the application of sodium perborate on wound healing in the roof of the mouth: a pilot randomized clinical trial

INTERVENTION: 12 patients who needed a gingival graft in two areas to correct mucogingival deformities participated in this split‐mouth study. The surgeries of each were performed at the same time with removal of bilateral free gingival graft on the palate. The size of the removed grafts was the same for both sides and defined by the need for the largest recipient area. One side of the donor area was treated with a sodium perborate gel (test side) and the other side received no treatment (control side).The side to be treated was randomized by coin toss right after the surgery. The product was applied twice a day for 56 days and kept in place by an acetate vacuum tray that was used for 24 hours a day throughout the study period. D006861 D010100 D013515 D014182 CONDITION: D005881 D014945 D060745 Gingiva; Gingival Retraction Techniques; Other periodontal diseases; Wound Healing K05.5 PRIMARY OUTCOME: 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. INCLUSION CRITERIA: Healthy subjects requiring bilateral gingival graft for corrections of mucogingival or peri‐implant deformities; non smokers; both genders. SECONDARY OUTCOME: 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.