Clinical trial NCT03655158: The Effects of Ozone Therapy on Wound Healing
Official title: The Effects of Ozone Therapy on Wound Healing After Gingivectomy Operations: a Controlled Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wound Heal
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
First posted: 2018-08-31
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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)
Primary purpose: TREATMENT

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.

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

Eligibility criteria: 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.

Primary outcomes:
measure: wound healing change
timeFrame: At baseline and 3rd, 7th, 14th days after surgery, wound healing evaluation were performed.
Secondary outcomes:
measure: Pain change
timeFrame: Postoperative pain was assessed at 3rd, 7th, 14th days after surgery
Other outcomes:
Locations:
city: Kayseri
country: Turkey
facility: Zekeriya Taşdemir
state: Türkiye
Study officials:
affiliation: TC Erciyes University
name: Zekeriya Taşdemir, Phd
role: PRINCIPAL_INVESTIGATOR
References: