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Effect of Ozonated Oil on Healing of Palatal Area.

NCT05620550 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2022-11-21

No results posted yet for this study

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%.

Conditions

  • Healing Surgical Wounds

Interventions

PROCEDURE

ozonated oil

Post operative scar treatment with ozonated oil

PROCEDURE

non ozonated oil

Post operative scar treatment with non ozonated oil

Sponsors & Collaborators

  • Universidade Federal Fluminense

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-12-31
Primary Completion
2023-01-31
Completion
2023-02-28

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05620550 on ClinicalTrials.gov