The Effect of Ozone Therapy on Pain Perception After Free Gingival Graft Surgery in Patients With Mucogingival Defects
1 other identifier
interventional
20
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 22, 2022
CompletedFirst Posted
Study publicly available on registry
March 23, 2022
CompletedStudy Start
First participant enrolled
June 15, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 15, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 25, 2022
CompletedFebruary 14, 2023
February 1, 2023
6 months
February 22, 2022
February 13, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
7 days
Evaluation of postoperative pain
The participants will report the number of analgesic tablets ingested to relieve the pain.
7 days
Secondary Outcomes (1)
Evaluation of complete epithelialization of the palatal wound.
28 days
Study Arms (2)
group 1, test group
EXPERIMENTALThis group will receive ozone therapy after harvesting of the free gingival graft from the palatal donor site.
group 2, control group
NO INTERVENTIONFollowing 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.
Interventions
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)
Eligibility Criteria
You may qualify if:
- 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%.
You may not qualify if:
- Smoking
- Pregnancy and lactation.
- History of systematic diseases or medications that interferes with periodontal wound healing.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cairo University-Faculty of Dentistry
Cairo, Manial, Giza, 12613, Egypt
Related Publications (2)
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.
PMID: 3858263BACKGROUNDOzcan 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.
PMID: 28817141BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Manal Hosny, Professor
Professor of Oral Diagnosis,Oral Medicine and Periodontology Faculty of Dentistry,Cairo University.
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Masking Details
- Double- blinded
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principle investigator
Study Record Dates
First Submitted
February 22, 2022
First Posted
March 23, 2022
Study Start
June 15, 2022
Primary Completion
December 15, 2022
Study Completion
December 25, 2022
Last Updated
February 14, 2023
Record last verified: 2023-02
Data Sharing
- IPD Sharing
- Will not share
The shared measures; clinical parameters will be shared pain perception by VAS scale, complete epitheliazation, evaluation of soft tissue healing at donor site.