Open Wound of Palate Without ComplicationNCT05291715
The Effect of Ozone Therapy on Pain Perception After Free Gingival Graft Surgery in Patients With Mucogingival Defects
A study testing Ozone generator device (Ozone DTA-APOZAa-enterprize CO9-Taiwan, R.0.C) in people with Open Wound of Palate Without Complication and Pain, Postoperative, run by Omaima Mossad Mahmoud AL-Sherbini at 1 site in Egypt.
Trial summary
Gaseous ozone (O3-triatomic oxygen) is the third-strongest oxidizing agent worldwide. It influences the cellular and the humoral immune system, by stimulating the proliferation of immunocompetent cells and the synthesis of immunoglobulin. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Open Wound of Palate Without Complication, Pain, Postoperative, Free Gingival Grafts
- What is being tested?
- Ozone generator device (Ozone DTA-APOZAa-enterprize CO9-Taiwan, R.0.C)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jun 2022to 25 Dec 2022
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients with mucogingival defects to be treated with free gingival grafts.
- Age older than 18 years old.
- No history of periodontal surgery in the area to be treated.
- Full mouth plaque score (FMPS) and full mouth bleeding score (FMBS) less than 20%.
Who cannot join
- Smoking
- Pregnancy and lactation.
- History of systematic diseases or medications that interferes with periodontal wound healing.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Ozone Therapy on Pain Perception After Free Gingival Graft Surgery in Patients With Mucogingival Defects A Randomized Controlled Clinical Trail
Gaseous ozone (O3-triatomic oxygen) is the third-strongest oxidizing agent worldwide. It influences the cellular and the humoral immune system, by stimulating the proliferation of immunocompetent cells and the synthesis of immunoglobulin. Additionally; biologically active substances, such as interleukins, leukotrienes and prostaglandins which are beneficial in reducing inflammation and wound healing are orchestrated following ozone application. Given that after harvesting of a free gingival graft from the palatal donor site, healing occurs by secondary intention process; for patients with mucogingival conditions. The investigators will compare the natural process of healing at the donor site versus the healing process consecutive to ozone application; with the primary outcome is to evaluate the postoperative pain perception using visual analogue scale and to estimate the consumption of analgesics tablets after surgery.
Read the detailed description
The procedures will be explained to all participants and they will be asked to sign an informed consent.
All patients will receive oral hygiene instructions and will receive phase I therapy comprising supragingival scaling and subgingival debridement.
After completion of phase I therapy the patients will be re-examined to ensure meeting all inclusion criteria. Then the participants will be allocated to 2 groups.
Group I will receive ozone therapy after harvesting free gingival graft. Group II following the harvesting of the free gingival graft, will be protected by a periodontal pack.
Surgical intervention:
Graft harvesting at donor site (Sullivan, \& Atkins, 1968) To prepare the donor area, a rectangular-shape incision with 1-1.5 mm thickness will be made, and care will be taken to place most of the coronal part of the incision at least 2 mm apical from gingival margins of the upper teeth. The apical coronal dimension of the graft.
Following administration of anaesthesia by local infiltration (2% lidocaine with 1:100,000 epinephrine), a template will be placed over the palatal mucosa and will be used to outline the dimensions of the graft. The area chosen to harvest the free gingival graft will be chosen between first premolar and first molar.
The outlined graft will be carefully harvested as follows: The surgical blade entered in the contour incision, always in the posterior limit, sliding below the mucosa, and continued to find the opposite contour incision, in the anterior limit. The connective tissue surface will be carefully inspected for irregularities or adipose tissue after graft separation. Graft thickness will be immediately prepared (thinned) to obtain a graft approximately 1 to 1.5 mm thick.
The palatal wound will be protected by a periodontal pack; for the control group.
While the test group, will receive ozone therapy.
Ozone Application Protocol:
An ozone generator device (Ozone DTA-APOZAa- enterPrize Co9-Taiwan,R.0,C) with different probe numbers (#1 pointed probe,#2 pointed probe and #3 flat probe) will be used according to the manufacturer's instructions. Ozone will be applied on donor sites immediately after surgery and at days 1, 3, 7, 14 post-surgeries in the test group with output power at level 6-12 for 1 minute.
Ozone application in the control group will be simulated without starting the ozone generator.
Postoperative Protocol:
The participants will be instructed to abstain from brushing and flossing the teeth at the surgical area until suture removal (7days) and to use an antimicrobial rinse (0.12% chlorhexidine, 15 ml for 60 seconds twice daily) solution two times a day for 4 weeks.
The participants will be also instructed to consume only soft foods during the first week and to avoid any other mechanical trauma to the treated sites.
The participants will be given a prescription of Ibuprofen (600 mg every 12 hours) to be taken if necessary and the participants will be asked to record the number of tablets taken.
Participants will be enrolled in a professional plaque control program weekly for the first 4 weeks, then monthly until the end of the study.
- Conditions
- Open Wound of Palate Without Complication, Pain, Postoperative, Free Gingival Grafts, Mucogingival Defects, Gingival Recession, Donor Site
- Being tested
- Ozone generator device (Ozone DTA-APOZAa-enterprize CO9-Taiwan, R.0.C)
- Keywords
- Ozone, Therapy, Pain, Gingival, Palatal, Donor, site, Recession, Mucogingival, Defects, Free, Grafts
- Medical subject headings
- Pain, Postoperative, Gingival Recession, Patient Satisfaction, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ozone generator device (Ozone DTA-APOZAa-enterprize CO9-Taiwan, R.0.C)Device
Gaseous ozone ( O3-triatomic oxygen) activates the neuroprotective systems, improve the blood circulation, oxygen delivery, stimulate the immunocompetent cells and enhance the release of growth factors. Moreover, ozone therapy showed to increase the quality of life post-operatively to a free gingival graft harvesting and decrease post-operative pain sensation ( Tasdemir et al, 2016)
| Study group | Role | What they receive |
|---|---|---|
| group 1, test group | Experimental | This group will receive ozone therapy after harvesting of the free gingival graft from the palatal donor site. Receives: Device: Ozone generator device (Ozone DTA-APOZAa-enterprize CO9-Taiwan, R.0.C) |
| group 2, control group | No intervention | Following harvesting of the free gingival graft, the palatal donor site ozone application will be simulated without starting of the ozone generator and the covered ( protected) by a periodontal pack. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of postoperative pain using visual analog scale.
Postoperative pain will be evaluated by visual analog scale (VAS) (Crichton, 2001).
In this method, the patients will be asked to rate their pain at examination in form of a score between 0 (no pain) and 10 (the most pain which patient has ever experienced).
This assessment will be made every day for the first 7 days following the FGG operation.
Measured: 7 days
Evaluation of postoperative pain
The participants will report the number of analgesic tablets ingested to relieve the pain.
Measured: 7 days
Secondary outcomes (1)
Evaluation of complete epithelialization of the palatal wound.
Hydrogen peroxide test (H 2 O 2) for assessment of epithelialization in control and test groups and at days 7, 14, 21 and 28, a 3% H 2 O 2 will be sprinkled on the palatal wounds by using a syringe. If the epithelium is discontinuous, it diffuses into the connective tissue, and the enzyme catalase acts on H 2 O 2 to release water and oxygen showing bubbles on the wound of FGG. Complete epithelialization will be scored clinically, following visual inspection (Yes, no). If the epithelial barrier is intact, then H2O2 does not diffuse into the connective tissue, it is not acted upon by catalase, and oxygen is not liberated. Absence of bubble formation following hydrogen peroxide application will be scored as positive complete epithelialization (Silva et al.,2010).
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2022
- Study start15 Jun 2022
- Primary completion15 Dec 2022
- Study completion25 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Open Wound of Palate Without ComplicationStudies of the same condition, open and under way.
- 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
- Group 1: Will receive ozone therapy after harvesting a free gingival graft. Group 2: Following the harvesting of the free gingival graft; the palatal donor site will be protected by a periodontal pack.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Omaima Mossad Mahmoud AL-Sherbini
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Omaima Mossad Mahmoud AL-Sherbini, Cairo University
- Investigators
- Manal Hosny, Professor, Study director, Professor of Oral Diagnosis,Oral Medicine and Periodontology Faculty of Dentistry,Cairo University.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05291715
- Sponsor's protocol ID
- 131221
- Status last verified
- Feb 2023
- First submitted
- 22 Feb 2022
- Last updated
- 14 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The shared measures; clinical parameters will be shared pain perception by VAS scale, complete epitheliazation, evaluation of soft tissue healing at donor site.
Publications
Miller PD Jr. Root coverage using the free soft tissue autograft following citric acid application. III. A successful and predictable procedure in areas of deep-wide recession. Int J Periodontics Restorative Dent. 1985;5(2):14-37. No abstract available.
PubMed 3858263Ozcan M, Ucak O, Alkaya B, Keceli S, Seydaoglu G, Haytac MC. Effects of Platelet-Rich Fibrin on Palatal Wound Healing After Free Gingival Graft Harvesting: A Comparative Randomized Controlled Clinical Trial. Int J Periodontics Restorative Dent. 2017 Sep/Oct;37(5):e270-e278. doi: 10.11607/prd.3226.
PubMed 28817141
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Ozone Therapy on Pain Perception After Free Gingival Graft Surgery in Patients With Mucogingival Defects A Randomized Controlled Clinical Trail
- ClinicalTrials.gov ID
- NCT05291715
- Acronym / sponsor ID
- 131221
- Conditions
- Open Wound of Palate Without Complication, Pain, Postoperative, Free Gingival Grafts, Mucogingival Defects, Gingival Recession, Donor Site
- Keywords
- Ozone, Therapy, Pain, Gingival, Palatal, Donor, site, Recession
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Omaima Mossad Mahmoud AL-SherbiniUniversity, hospital or other
- Study start
- 15 Jun 2022 (actual)
- Primary completion
- 15 Dec 2022 (actual)
- Study completion
- 25 Dec 2022 (actual)
- First posted
- 23 Mar 2022 (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.
Gaseous ozone (O3-triatomic oxygen) is the third-strongest oxidizing agent worldwide. It influences the cellular and the humoral immune system, by stimulating the proliferation of immunocompetent cells and the synthesis of immunoglobulin. Additionally; biologically active substances, such as interleukins, leukotrienes and prostaglandins which are beneficial in reducing inflammation and wound healing are orchestrated following ozone application. Given that after harvesting of a free gingival graft from the palatal donor site, healing occurs by secondary intention process; for patients with mucogingival conditions. The investigators will compare the natural process of healing at the donor site versus the healing process consecutive to ozone application; with the primary outcome is to evaluate the postoperative pain perception using visual analogue scale and to estimate the consumption of analgesics tablets after surgery.
Detailed description
The procedures will be explained to all participants and they will be asked to sign an informed consent.
All patients will receive oral hygiene instructions and will receive phase I therapy comprising supragingival scaling and subgingival debridement.
After completion of phase I therapy the patients will be re-examined to ensure meeting all inclusion criteria. Then the participants will be allocated to 2 groups.
Group I will receive ozone therapy after harvesting free gingival graft. Group II following the harvesting of the free gingival graft, will be protected by a periodontal pack.
Surgical intervention:
Graft harvesting at donor site (Sullivan, \& Atkins, 1968) To prepare the donor area, a rectangular-shape incision with 1-1.5 mm thickness will be made, and care will be taken to place most of the coronal part of the incision at least 2 mm apical from gingival margins of the upper teeth. The apical coronal dimension of the graft.
Following administration of anaesthesia by local infiltration (2% lidocaine with 1:100,000 epinephrine), a template will be placed over the palatal mucosa and will be used to outline the dimensions of the graft. The area chosen to harvest the free gingival graft will be chosen between first premolar and first molar.
The outlined graft will be carefully harvested as follows: The surgical blade entered in the contour incision, always in the posterior limit, sliding below the mucosa, and continued to find the opposite contour incision, in the anterior limit. The connective tissue surface will be carefully inspected for irregularities or adipose tissue after graft separation. Graft thickness will be immediately prepared (thinned) to obtain a graft approximately 1 to 1.5 mm thick.
The palatal wound will be protected by a periodontal pack; for the control group.
While the test group, will receive ozone therapy.
Ozone Application Protocol:
An ozone generator device (Ozone DTA-APOZAa- enterPrize Co9-Taiwan,R.0,C) with different probe numbers (#1 pointed probe,#2 pointed probe and #3 flat probe) will be used according to the manufacturer's instructions. Ozone will be applied on donor sites immediately after surgery and at days 1, 3, 7, 14 post-surgeries in the test group with output power at level 6-12 for 1 minute.
Ozone application in the control group will be simulated without starting the ozone generator.
Postoperative Protocol:
The participants will be instructed to abstain from brushing and flossing the teeth at the surgical area until suture removal (7days) and to use an antimicrobial rinse (0.12% chlorhexidine, 15 ml for 60 seconds twice daily) solution two times a day for 4 weeks.
The participants will be also instructed to consume only soft foods during the first week and to avoid any other mechanical trauma to the treated sites.
The participants will be given a prescription of Ibuprofen (600 mg every 12 hours) to be taken if necessary and the participants will be asked to record the number of tablets taken.
Participants will be enrolled in a professional plaque control program weekly for the first 4 weeks, then monthly until the end of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Group 1: Will receive ozone therapy after harvesting a free gingival graft. Group 2: Following the harvesting of the free gingival graft; the palatal donor site will be protected by a periodontal pack.
| Arm | Type | Receives |
|---|---|---|
| group 1, test group | Experimental | Device: Ozone generator device (Ozone DTA-APOZAa-enterprize CO9-Taiwan, R.0.C)This group will receive ozone therapy after harvesting of the free gingival graft from the palatal donor site. |
| group 2, control group | No intervention | –Following harvesting of the free gingival graft, the palatal donor site ozone application will be simulated without starting of the ozone generator and the covered ( protected) by a periodontal pack. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients with mucogingival defects to be treated with free gingival grafts.
- Age older than 18 years old.
- No history of periodontal surgery in the area to be treated.
- Full mouth plaque score (FMPS) and full mouth bleeding score (FMBS) less than 20%.
Key exclusion criteria (3 listed)
- Smoking
- Pregnancy and lactation.
- History of systematic diseases or medications that interferes with periodontal wound healing.
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 generator device (Ozone DTA-APOZAa-enterprize CO9-Taiwan, R.0.C)Gaseous ozone ( O3-triatomic oxygen) activates the neuroprotective systems, improve the blood circulation, oxygen delivery, stimulate the immunocompetent cells and enhance the release of growth factors. Moreover, ozone therapy showed to increase the quality of life post-operatively to a free gingival graft harvesting and decrease post-operative pain sensation ( Tasdemir et al, 2016) | Device | group 1, test group |
Primary outcome
Evaluation of postoperative pain using visual analog scale.
Time frame: 7 days
Postoperative pain will be evaluated by visual analog scale (VAS) (Crichton, 2001). In this method, the patients will be asked to rate their pain at examination in form of a score between 0 (no pain) and 10 (the most pain which patient has ever experienced). This assessment will be made every day for the first 7 days following the FGG operation.
Evaluation of postoperative pain
Time frame: 7 days
The participants will report the number of analgesic tablets ingested to relieve the pain.
1 secondary outcome
Evaluation of complete epithelialization of the palatal wound.
Time frame: 28 days
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 14 Feb 2023.
- Background: PubMed 3858263Miller PD Jr. Root coverage using the free soft tissue autograft following citric acid application. III. A successful and predictable procedure in areas of deep-wide recession. Int J Periodontics Restorative Dent. 1985;5(2):14-37. No abstract available.
- Background: PubMed 28817141Ozcan M, Ucak O, Alkaya B, Keceli S, Seydaoglu G, Haytac MC. Effects of Platelet-Rich Fibrin on Palatal Wound Healing After Free Gingival Graft Harvesting: A Comparative Randomized Controlled Clinical Trial. Int J Periodontics Restorative Dent. 2017 Sep/Oct;37(5):e270-e278. doi: 10.11607/prd.3226.
- Individual participant dataSharing planned: No. The shared measures; clinical parameters will be shared pain perception by VAS scale, complete epitheliazation, evaluation of soft tissue healing at donor site.
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.
Manal Hosny, Professor study director
Professor of Oral Diagnosis,Oral Medicine and Periodontology Faculty of Dentistry,Cairo 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 generator device (Ozone DTA-APOZAa-enterprize CO9-Taiwan, R.0.C) in people with Open Wound of Palate Without Complication and Pain, Postoperative, run by Omaima Mossad Mahmoud AL-Sherbini at 1 site in Egypt.
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 4 inclusion and 3 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 14 Feb 2023. 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 Egypt. 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?
Evaluation of postoperative pain using visual analog scale. (time frame: 7 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05291715, which also lists 2 linked publications.
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 14 Feb 2023.