The Effects of Ozone Therapy on Wound Healing

Study Overview
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Brief Summary
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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.

Detailed Description
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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

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

Conditions
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Wound Heal

Intervention / Treatment
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* Device: ozone device ( Ozonytron XL )


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Split- mouth placebo controlled design (right quadrants of the surgical areas were assigned to receive ozone therapy in all patients. As placebo application, left quadrants received regular air from the ozone generator)
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ozone group<br>After gingivectomy and gingivoplasty, right quadrants of the surgical areas were assigned to receive ozone therapy in all patients | Device: ozone device ( Ozonytron XL )<br>* The adjustment of the ozone generator was %75 power for 30 seconds (75 ug/ml) based on manufacturer's instructions<br>|
| No Intervention: non-ozone group<br>placebo application, left quadrants received regular air from the ozone generator. | |

What is the study measuring?
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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 |