The Effects of Ozone Therapy on Wound Healing

NCT03655158 | Completed

• 1 other identifier: Zektaşdemir
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Wound Heal

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Pain change

  Postoperative pain was assessed at 3rd, 7th, 14th days after surgery

Study Arms (2)

ozone group

EXPERIMENTAL

After gingivectomy and gingivoplasty, right quadrants of the surgical areas were assigned to receive ozone therapy in all patients

Device: ozone device ( Ozonytron XL )

non-ozone group

NO INTERVENTION

placebo application, left quadrants received regular air from the ozone generator.

Interventions

ozone device ( Ozonytron XL ) DEVICE

The adjustment of the ozone generator was %75 power for 30 seconds (75 ug/ml) based on manufacturer's instructions

ozone group

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• \<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.

Sponsors & Collaborators

• TC Erciyes University: lead

Study Sites (1)

Zekeriya Taşdemir

Kayseri, Türkiye, 38039, Turkey (Türkiye)

Location

Study Officials

• Zekeriya Taşdemir, Phd

  TC Erciyes University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: placebo applications were performed to mask participant investigator who applied ozone, did not evaluate the healing Investigator who evaluate the healing, did not know the control and test sides.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: 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)

Study Record Dates

• First Submitted: August 29, 2018
• First Posted: August 31, 2018
• Study Start: February 10, 2017
• Primary Completion: November 10, 2017
• Study Completion: November 10, 2017
• Last Updated: October 23, 2018

Record last verified: 2018-10

Locations

TU (1)