Effect of Ozonated Oil on Healing of Palatal Area.

NCT05620550 | Unknown

• 1 other identifier: Ozonated
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Healing; Ozone; Autografts; Oral mucosa

Outcome Measures

Primary Outcomes (1)

• Healing

  The primary outcome will be the remaining scar area of the palate, using a healing score, confronting clinical results with biomarkers colected from scar area.

  3 months

Secondary Outcomes (1)

• Post operative pain and discomfort

  3 months

Other Outcomes (1)

• Quality of life scores

  3 months

Study Arms (2)

ozonated oil

EXPERIMENTAL

treatment of scar area with ozonated oil

Procedure: ozonated oil

non ozonated oil

SHAM COMPARATOR

treatment of scar area with non ozonated oil

Procedure: non ozonated oil

Interventions

ozonated oil PROCEDURE

Post operative scar treatment with ozonated oil

ozonated oil

non ozonated oil PROCEDURE

Post operative scar treatment with non ozonated oil

non ozonated oil

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients aged between 18 and 60 years
• Good general systemic health (self-reported by the patient)
• Plaque index and gingival index \<25%
• Indication of tooth extraction and preservation of the alveolar ridge
• No morphological or pathological changes in the palate

You may not qualify if:

• Systemic disease (e.g. diabetes with glycosylated hemoglobin \>7%, cancer, HIV, chronic inflammatory diseases, etc ) and/or with any surgical contraindication
• Patients requiring antibiotic prophylaxis or who have used systemic antibiotics corticosteroids, anti- inflammatory drugs or immunosuppressants in the last three months
• Smokers,
• Patients who have had previous periodontal surgery to remove a graft in the palate area
• Pregnant or breastfeeding
• Use of medications that interfere with healing
• Patients who present oral lesions and/or in the palate region
• Total maxillary edentulism, which makes it impossible to remove the free gingival graft due to intense resorption of the alveolar ridge

Sponsors & Collaborators

• Universidade Federal Fluminense: lead

Study Sites (1)

Universidade Federal Fluminense

Nova Friburgo, Rio de Janeiro, 28625-650, Brazil

Location

Related Publications (8)

• Anzolin AP, da Silveira-Kaross NL, Bertol CD. Ozonated oil in wound healing: what has already been proven? Med Gas Res. 2020 Jan-Mar;10(1):54-59. doi: 10.4103/2045-9912.279985.

  PMID: 32189671 RESULT

• Avila-Ortiz G, Chambrone L, Vignoletti F. Effect of alveolar ridge preservation interventions following tooth extraction: A systematic review and meta-analysis. J Clin Periodontol. 2019 Jun;46 Suppl 21:195-223. doi: 10.1111/jcpe.13057. Erratum In: J Clin Periodontol. 2020 Jan;47(1):129. doi: 10.1111/jcpe.13212.

  PMID: 30623987 RESULT

• Dias SB, Fonseca MV, Dos Santos NC, Mathias IF, Martinho FC, Junior MS, Jardini MA, Santamaria MP. Effect of GaAIAs low-level laser therapy on the healing of human palate mucosa after connective tissue graft harvesting: randomized clinical trial. Lasers Med Sci. 2015 Aug;30(6):1695-702. doi: 10.1007/s10103-014-1685-2. Epub 2014 Nov 6.

  PMID: 25373688 RESULT

• Isler SC, Uraz A, Guler B, Ozdemir Y, Cula S, Cetiner D. Effects of Laser Photobiomodulation and Ozone Therapy on Palatal Epithelial Wound Healing and Patient Morbidity. Photomed Laser Surg. 2018 Nov;36(11):571-580. doi: 10.1089/pho.2018.4492. Epub 2018 Sep 27.

  PMID: 30260741 RESULT

• Kumar T, Arora N, Puri G, Aravinda K, Dixit A, Jatti D. Efficacy of ozonized olive oil in the management of oral lesions and conditions: A clinical trial. Contemp Clin Dent. 2016 Jan-Mar;7(1):51-4. doi: 10.4103/0976-237X.177097.

  PMID: 27041901 RESULT

• Miguel MMV, Mathias-Santamaria IF, Rossato A, Ferraz LFF, Figueiredo-Neto AM, de Marco AC, Casarin RCV, Wallet SM, Tatakis DN, Mathias MA, Santamaria MP. Microcurrent electrotherapy improves palatal wound healing: Randomized clinical trial. J Periodontol. 2021 Feb;92(2):244-253. doi: 10.1002/JPER.20-0122. Epub 2020 Aug 30.

  PMID: 32783220 RESULT

• Travagli V, Zanardi I, Valacchi G, Bocci V. Ozone and ozonated oils in skin diseases: a review. Mediators Inflamm. 2010;2010:610418. doi: 10.1155/2010/610418. Epub 2010 Jul 4.

  PMID: 20671923 RESULT

• Wessel JR, Tatakis DN. Patient outcomes following subepithelial connective tissue graft and free gingival graft procedures. J Periodontol. 2008 Mar;79(3):425-30. doi: 10.1902/jop.2008.070325.

  PMID: 18315424 RESULT

Central Study Contacts

Elizangela Zuza, PhD

CONTACT

16 981996777; elizangelazuza@id.uff.br

Alessandra A Souza, PhD

CONTACT

21987476672; alessandraareas@id.uff.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Patients will receive ramdomly one of the bottles with oil, identified as A or B. One contains sunfower ozonated oil and the other non ozonated sunflower oil. Both the patient and the operator will be blinded,
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: This is a prospective longitudinal clinical trial, being a patient-centered, double-blinded (patient and examiner), randomized by lottery, placebo-controlled study.

Study Record Dates

• First Submitted: October 3, 2022
• First Posted: November 17, 2022
• Study Start: December 1, 2022
• Primary Completion: January 1, 2023
• Study Completion: February 1, 2023
• Last Updated: November 21, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)