Wound HealNCT03655158
The Effects of Ozone Therapy on Wound Healing
A study testing ozone device ( Ozonytron XL ) in people with Wound Heal, run by TC Erciyes University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Wound Heal
- What is being tested?
- ozone device ( Ozonytron XL )
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Feb 2017to 10 Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- <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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Ozone Therapy on Wound Healing After Gingivectomy Operations: a Controlled Clinical Study
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.
Read the 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
- Conditions
- Wound Heal
- Being tested
- ozone device ( Ozonytron XL )
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| ozone group | Experimental | After gingivectomy and gingivoplasty, right quadrants of the surgical areas were assigned to receive ozone therapy in all patients Receives: Device: ozone device ( Ozonytron XL ) |
| non-ozone group | No intervention | placebo application, left quadrants received regular air from the ozone generator. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At baseline and 3rd, 7th, 14th days after surgery, wound healing evaluation were performed.
Secondary outcomes (1)
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).
Measured: Postoperative pain was assessed at 3rd, 7th, 14th days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2018
- Study start10 Feb 2017
- Primary completion10 Nov 2017
- Study completion10 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound HealStudies of the same condition, open and under way.
- More trials run by TC Erciyes UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zekeriya Tasdemir, TC Erciyes University
- Investigators
- Zekeriya Taşdemir, Phd, Principal investigator, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03655158
- Sponsor's protocol ID
- Zektaşdemir
- Status last verified
- Oct 2018
- First submitted
- 29 Aug 2018
- Last updated
- 23 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Ozone Therapy on Wound Healing After Gingivectomy Operations: a Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT03655158
- Acronym / sponsor ID
- Zektaşdemir
- Conditions
- Wound Heal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 10 Feb 2017 (actual)
- Primary completion
- 10 Nov 2017 (actual)
- Study completion
- 10 Nov 2017 (actual)
- First posted
- 31 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- 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)
| Arm | Type | Receives |
|---|---|---|
| ozone group | Experimental | Device: ozone device ( Ozonytron XL )After gingivectomy and gingivoplasty, right quadrants of the surgical areas were assigned to receive ozone therapy in all patients |
| non-ozone group | No intervention | –placebo application, left quadrants received regular air from the ozone generator. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 18 to 35 years of age
- systemically healthy
- non-smokers
- no medications taken for 6 months
- no pregnancy and lactation
Key exclusion criteria (7 listed)
- <18 and > 35 years of age
- systemical disease
- smoking and alcohol consumption
- medications taken for 6 months
- pregnancy and lactation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ozone device ( Ozonytron XL )The adjustment of the ozone generator was %75 power for 30 seconds (75 ug/ml) based on manufacturer's instructions | Device | ozone group |
Primary outcome
wound healing change
Time frame: At baseline and 3rd, 7th, 14th days after surgery, wound healing evaluation were performed.
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
1 secondary outcome
Pain change
Time frame: Postoperative pain was assessed at 3rd, 7th, 14th days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Wound Heal
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Feasibility of a Digital Self-help Program for Functional Hypothalamic Amenorrhea (HEAL-FHA Pilot)
Functional Hypothalamic Amenorrhea
Active, not recruitingPhase 1
E-CEL UVEC Cells as an Adjunct Cell Therapy for the Arthroscopic Rotator Cuff Repair in Adults
Rotator Cuff Tears, Muscle Atrophy or Weakness
Active, not recruiting
Alveolar Ridge Reconstruction in Post-extraction Sites Using a Magnesium Resorbable Membrane. An Explorative Study
Bone Augmentation, Alveolar Ridge Augmentation
Recruiting
Effect Of Resistive Capactive Electrical Transfer Therapy In Difficult-to-heal Wounds
Difficult-to-heal Wounds
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zekeriya Taşdemir, Phd principal investigator
TC Erciyes University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ozone device ( Ozonytron XL ) in people with Wound Heal, run by TC Erciyes University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
wound healing change (time frame: At baseline and 3rd, 7th, 14th days after surgery, wound healing evaluation were performed.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2018.