The Effects of Ozone Therapy on Wound Healing
Primary Purpose
Wound Heal
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
ozone device ( Ozonytron XL )
Sponsored by
About this trial
This is an interventional treatment trial for Wound Heal
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.
Sites / Locations
- Zekeriya Taşdemir
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
ozone group
non-ozone group
Arm Description
After gingivectomy and gingivoplasty, right quadrants of the surgical areas were assigned to receive ozone therapy in all patients
placebo application, left quadrants received regular air from the ozone generator.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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).
Full Information
NCT ID
NCT03655158
First Posted
August 29, 2018
Last Updated
October 20, 2018
Sponsor
TC Erciyes University
1. Study Identification
Unique Protocol Identification Number
NCT03655158
Brief Title
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
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
February 10, 2017 (Actual)
Primary Completion Date
November 10, 2017 (Actual)
Study Completion Date
November 10, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
TC Erciyes University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wound Heal
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantInvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ozone group
Arm Type
Experimental
Arm Description
After gingivectomy and gingivoplasty, right quadrants of the surgical areas were assigned to receive ozone therapy in all patients
Arm Title
non-ozone group
Arm Type
No Intervention
Arm Description
placebo application, left quadrants received regular air from the ozone generator.
Intervention Type
Device
Intervention Name(s)
ozone device ( Ozonytron XL )
Intervention Description
The adjustment of the ozone generator was %75 power for 30 seconds (75 ug/ml) based on manufacturer's instructions
Primary Outcome Measure Information:
Title
wound healing change
Description
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
Time Frame
At baseline and 3rd, 7th, 14th days after surgery, wound healing evaluation were performed.
Secondary Outcome Measure Information:
Title
Pain change
Description
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).
Time Frame
Postoperative pain was assessed at 3rd, 7th, 14th days after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zekeriya Taşdemir, Phd
Organizational Affiliation
TC Erciyes University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zekeriya Taşdemir
City
Kayseri
State/Province
Türkiye
ZIP/Postal Code
38039
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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The Effects of Ozone Therapy on Wound Healing
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