The Effects of Ozone Therapy on Wound Healing

The Effects of Ozone Therapy on Wound Healing After Gingivectomy Operations: a Controlled Clinical Study

the aim of present study was to evaluate effects of ozone therapy on wound healing after gingivectomy and gingivoplasty operations as a model of secondary wound healing.. Twenty three systemically healthy individuals participated in this study. Ozone was applied immediately after surgery, at 1st day and 3rd day after gingivectomy surgery. In the photographs of the wounds, the difference in color were evaluated and measurements were performed at the baseline, 3rd, 7th, 14th days after surgery.

Study Overview

• Status: Completed
• Conditions: Wound Heal
• Intervention / Treatment: Device: ozone device ( Ozonytron XL )

Detailed Description

Although ozone therapy has often been tried in medical science and has become more popular due to its antimicrobial, biocompatibility and healing properties, the effects of ozone therapy on surgeries that heals with secondary intention were not studied. In the lights of these informations, the aim of present study was to evaluate effects of ozone therapy on wound healing after gingivectomy and gingivoplasty operations as a model of secondary wound healing. Twenty three systemically healthy individuals participated in this study. All periodontal examinations were performed by one experienced examiner and non-surgical periodontal treatment of the patients were performed within two weeks after initial examination by the same clinician.Gingivectomy and gingivoplasty operations were performed by another examiner who was unaware of the study protocol.After gingivectomy and gingivoplasty, right quadrants of the surgical areas were assigned to receive ozone therapy in all patients. Ozone therapy was also performed by an experienced periodontist. As placebo application, left quadrants received regular air from the ozone generator.Postoperative pain was assessed at 3rd, 7th, 14th days after surgery with a visual analog scale At baseline and 3rd, 7th, 14th days after surgery, surgical area was disclosed by a plaque disclosing solution to visualize the epithelization degree of the surgical areas. Solution provided a clear vision to distinguish normal gingiva from the areas in which the gingival epithelium is absent, abraded or lacking sufficient keratinization. In order to evaluate epithelization degree of the wounds, standardized photographs were taken from each patient.In the photographs of the wounds, the difference in color were evaluated and darkly stained areas were considered as lack of enough epithelization. These measurements were performed at the baseline, 3rd, 7th, 14th days after surgery. The determinations were done by a calibrated examiner who was blind to test and control sites

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Türkiye
    • Kayseri, Türkiye, Turkey, 38039
      • Zekeriya Taşdemir

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 18 to 35 years of age
• systemically healthy
• non-smokers
• no medications taken for 6 months
• no pregnancy and lactation
• no contraindications for periodontal surgery
• no gingivectomy or mucogingival surgical history in the lower incisor region.

Exclusion Criteria:

• <18 and > 35 years of age
• systemical disease
• smoking and alcohol consumption
• medications taken for 6 months
• pregnancy and lactation
• contraindications for periodontal surgery
• gingivectomy or mucogingival surgical history in the lower incisor region.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: ozone group; After gingivectomy and gingivoplasty, right quadrants of the surgical areas were assigned to receive ozone therapy in all patients	Device: ozone device ( Ozonytron XL ); The adjustment of the ozone generator was %75 power for 30 seconds (75 ug/ml) based on manufacturer's instructions
NO_INTERVENTION: non-ozone group; placebo application, left quadrants received regular air from the ozone generator.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
wound healing change	surgical area was disclosed by a plaque disclosing solution to visualize the epithelization degree of the surgical areas. Solution provided a clear vision to distinguish normal gingiva from the areas in which the gingival epithelium is absent, abraded or lacking sufficient keratinization. In order to evaluate epithelization degree of the wounds, standardized photographs were taken from each patient	At baseline and 3rd, 7th, 14th days after surgery, wound healing evaluation were performed.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain change	Visual analog scale was used for the pain assesment. On the scale, the left end of the graphic represented the absence of pain (score 0) and the right end represented the most severe pain (score 10).	Postoperative pain was assessed at 3rd, 7th, 14th days after surgery

Collaborators and Investigators

• Sponsor: TC Erciyes University

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 10, 2017
• Primary Completion (ACTUAL): November 10, 2017
• Study Completion (ACTUAL): November 10, 2017

Study Registration Dates

• First Submitted: August 29, 2018
• First Submitted That Met QC Criteria: August 29, 2018
• First Posted (ACTUAL): August 31, 2018

Study Record Updates

• Last Update Posted (ACTUAL): October 23, 2018
• Last Update Submitted That Met QC Criteria: October 20, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: Zektaşdemir

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No