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NCT05620550
Effect of Ozonated Oil on Healing of Palatal Area.
Conditions: Healing Surgical Wounds
Sex: All
Ages: 18 Years – 60 Years
Healthy volunteers: 1
Phase: NA
Enrollment: 28
Sponsor: Universidade Federal Fluminense
Location: Brazil
Summary
Despite the good clinical results and advantages of using autogenous grafts, such as subepithelial connective grafts and free gingival grafts, the removal of grafts from the palate can result in greater postoperative morbidity.
The objective of the present study will be to perform a clinical evaluation of the effect of ozonated oil on the healing of palatal wounds, after the removal of free gingival grafts, to be used in the post-extraction sockets, with the purpose of preserving the alveolar ridge.
This is a prospective longitudinal clinical trial, being a patient-centered, double-blind, randomized by lottery, placebo- controlled study.
The groups will be divided as follows: 1) EGL Group (control): after the removal of the EGL, the palatal wound will be treated with non-ozonized sunflower oil (placebo), applied once a day, for seven days.
days; 2) EGL + Oz Group (test): after removal of the EGL, the palatal wound will be treated with ozonated sunflower oil with a peroxide index between 510 - 625 meq/kg (Oleozon®, São Paulo, Brazil), applied once a day, for seven days.
The clinical evaluation and the healing process will be evaluated through the remaining scar area (RSA), Epithelialization (E) and Tissue Edema (TE).
Assessments will be performed at baseline (after EGL removal) and at 3, 7, and 14 days.
Measurement of levels of Malondialdehyde (MDA) and 4-Hydroxinonenal (4-HNE) for oxidative stress will be performed at days 3 and 7. Quality of life questionnaire (OHIP-14) and pain scale (VAS) will be applied.
The data will initially be tested for normality by the Shapiro-Wilk test.
If the data are parametric, Analysis of Variance (ANOVA) can be applied, but if they are non-parametric, the Kruskal-Wallis test can be applied, followed by Dunns, for comparison between groups.
The significance level will be set at 5%.
Eligibility Criteria
Inclusion Criteria:Patients aged between 18 and 60 yearsGood general systemic health (self-reported by the patient)Plaque index and gingival index <25%Indication of tooth extraction and preservation of the alveolar ridgeNo morphological or pathological changes in the palateExclusion Criteria:Systemic disease (e.g.
diabetes with glycosylated hemoglobin >7%, cancer, HIV, chronic inflammatory diseases, etc ) and/or with any surgical contraindicationPatients requiring antibiotic prophylaxis or who have used systemic antibiotics corticosteroids, anti- inflammatory drugs or immunosuppressants in the last three monthsSmokers,Patients who have had previous periodontal surgery to remove a graft in the palate areaPregnant or breastfeedingUse of medications that interfere with healingPatients who present oral lesions and/or in the palate regionTotal maxillary edentulism, which makes it impossible to remove the free gingival graft due to intense resorption of the alveolar ridge
Source: ClinicalTrials.gov (NCT05620550). StuddyBuddy aggregates publicly available trial information.