The Effects of Ozone Therapy on Wound Healing

Wound Heal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03655158
• Other study ID #: Zektasdemir
• Status: Completed
• Phase: N/A
• Start date: February 10, 2017
• Est. completion date: November 10, 2017

Study information

• Verified date: October 2018
• Source: TC Erciyes University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: November 10, 2017
• Est. primary completion date: November 10, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Wound Heal
• Wounds and Injuries

Intervention

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

Locations

Country	Name	City	State
Turkey	Zekeriya Tasdemir	Kayseri	Türkiye

Sponsors (1)

Lead Sponsor	Collaborator
TC Erciyes University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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