The Effect of Ozone Therapy on Gingivoplasty

Not Applicable

Recruiting

• Conditions: Gingival Enlargement

• Registration Number: NCT06753305
• Lead Sponsor: Kutahya Health Sciences University

Brief Summary

Ozone therapy after gingivectomy and gingivoplasty has been found to reduce patients' pain levels and positively impact their quality of life. This study aimed to compare the healing potential of the wound surface following gingivectomy and gingivoplasty surgery applied to the maxillary anterior regions with classical periodontal paste application (Coe-pak) using activated oxygen (Cure 09 Active Oxygen) and classical periodontal paste application only (Coe-pak).

The study will include 48 systemically healthy patients older than 18 years of age with gingival enlargement in the maxillary anterior region, requiring gingivectomy and gingivoplasty surgery, who applied to Kütahya University of Health Sciences, Faculty of Dentistry, Department of Periodontology and Izmir Democracy University, Faculty of Dentistry, Department of Periodontology. Patients will be evaluated in two different groups as test and control group after surgery. Patients will be randomly divided into study groups by closed envelope method. The test group will receive periodontal paste (Coe-pak) + Ozone therapy (active oxygen (Cure 09 Active Oxygen)) after gingivectomy and gingivoplasty surgery, while the control group will receive only periodontal paste after gingivectomy and gingivoplasty surgery. All patients will undergo gingivectomy and gingivoplasty with the same procedure

Detailed Description

Gingival enlargement leads to unaesthetic appearance, increased susceptibility to periodontal disease and halitosis by making it difficult to control plaque, and chewing and speech disorders by affecting functional function. Gingivectomy and gingivoplasty are used for the excision of diseased gingiva or gingival enlargement to create a natural anatomical form of the gingiva and improve aesthetics. After gingivectomy and gingivoplasty surgery, secondary healing occurs at the wound site. Bleeding and pain as a result of secondary healing negatively affect the patient's quality of life. Many different treatment methods such as ozone therapy, laser therapy, antiseptic agents, platelet concentrate, and herbal products are applied to reduce postoperative complications and increase patient comfort after gingivectomy and gingivoplasty. Since ozone gas increases growth factors, activates local antioxidant mechanisms, and supports tissue repair, its application to the wound site prevents postoperative infection and may accelerate wound healing. Topical application of ozone gas has been reported to be effective in the early stages of wound healing by increasing the amount of vascular endothelial growth factor expression. In a systematic review aiming to evaluate the effectiveness of ozone therapy in reducing the symptoms of oral diseases, especially oral mucositis, which is a serious complication of cancer treatment, it was confirmed that ozone has analgesic, anti-inflammatory, antimicrobial, and regenerative properties. In a study, it was found that the application of ozone therapy after gingivectomy and gingivoplasty reduced the pain levels of patients and positively affected their quality of life. To compare the healing potential of the wound surface following gingivectomy and gingivoplasty surgery applied to the maxillary anterior regions with the application of classical periodontal paste (Coe-pak) using activated oxygen (Cure 09 Active Oxygen) and with the application of classical periodontal paste (Coe-pak) alone.

The study will include 48 systemically healthy, systemically healthy patients older than 18 years of age, with gingival enlargement in the maxillary anterior region, requiring gingivectomy and gingivoplasty surgery, who applied to Kütahya University of Health Sciences, Faculty of Dentistry, Department of Periodontology and İzmir Democracy University, Faculty of Dentistry, Department of Periodontology. All patients will be called for re-evaluation 4 weeks after phase 1 periodontal treatment and surgical treatment will be planned. Clinical measurements (plaque index, gingival index, pocket depth, bleeding index on probing, and gingival overgrowth index) and oral health impact profile-14 questionnaire will be recorded and standard photographs will be taken before surgery. After local anesthesia, the incision line will be determined with a marking press or periodontal probe according to the amount of gingival enlargement. An external beveled incision will be made along the determined incision line with a No. 15 scalpel. Once the incision is complete, the surrounding tissues will be cleaned using microsurgical scissors. Following this, gingivoplasty will be performed. Patients will be randomly assigned to either the test group or the control group. In the test group, periodontal paste (Coe-Pak) will be applied to the area designated for secondary healing after ozone therapy (Cure 09 Active Oxygen). In the control group, only periodontal paste (Coe-Pak) will be applied. Postoperatively, the patient will record the bleeding status, daily analgesic use, and pain and burning with a visual analog scale for the first 7 days. Standard photographs will be taken in the postoperative period, immediately after the placement of the patch and on the 7th, 14th and 21st days. In addition, clinical evaluations (healing index, inflammation, modified manchester scar scale, surgical Area Plaque index, re-epithelialisation evaluation, and only on the 7th day, plaque accumulation in the periodontal paste) will be recorded from the patients on the 7th, 14th, and 21st days.

Study Timeline

• Study Start: 2022-11-15
• Study First Submitted: 2024-11-27
• Status Verified: 2024-12
• Study First Submitted QC: 2024-12-20
• Last Update Submitted: 2024-12-20
• Study First Posted: 2024-12-31
• Last Update Posted: 2024-12-31
• Primary Completion: 2025-08-15
• Study Completion: 2025-08-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

1. be over 18 years old
2. Systemically healthy individuals
3. Gingival enlargement due to inflammation in at least 4 teeth in the maxillary anterior region
4. Horizontal and vertical gingival growth index score of 1 or 2
5. Gingival thickness more than 2 mm
6. Good oral hygiene
7. No loss of clinical attachment

Exclusion Criteria

1. Pregnancy
2. Hereditary gingival fibromatosis
3. Drug-induced gingival enlargement
4. Allergy
5. Presence of systemic conditions requiring antibiotic prophylaxis
6. Acute and untreated periodontitis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Gingival inflammation	1-month follow-up after gingivectomy and gingivoplasty surgery	The effect of ozone therapy on inflammation will be measured in the 1-month follow-up after gingivectomy and gingivoplasty surgery.; Inflammation 0=no inflammation,; 1. mild inflammation,; 2. moderate inflammation,; 3. severe inflammation
Gingival contour	1-month follow-up after gingivectomy and gingiplasty	The effect of ozone therapy on gingival contour after gingivectomy and gingivoplasty surgery was measured using the Modified Manchester Scar Scale at 1-month follow-up.; Modified Manchester Scar Scale (used to assess gingival colour, contour, and distortion) The colour of the wound compared to the adjacent mucosa score 0= perfect fit score 1= slight non-compliance score 2= obvious incompatibility The contour of the wound compared to the surrounding tissues score 0= similar score 1= slightly raised or indented score 2= hypertrophic Wound distortion score 0= no distortion score 1= slight distortion score 2= obvious distortion The total of the scores in the three categories indicates the wound healing score, the total score ranges from 0 to 6, with lower scores indicating better healing.
Re-epithelialisation evaluation	1-month follow-up after gingivectomy and gingivoplasty surgery	To measure the effect of ozone therapy on re-epithelialization after gingivectomy and gingivoplasty surgeries with toluidine blue or 3% H2O2 intraoral photographs at 1-month follow-up.
Gingival distortion	1-month follow-up after gingivectomy and gingiplasty	To measure the effect of ozone therapy on gingival distorrion via Modified Manchester Scar Scale after gingivectomy and gingivoplasty surgery at 1-month follow-up.; Modified Manchester Scar Scale (used to assess gingival colour, contour, and distortion) The colour of the wound compared to the adjacent mucosa score 0= perfect fit score 1= slight non-compliance score 2= obvious incompatibility The contour of the wound compared to the surrounding tissues score 0= similar score 1= slightly raised or indented score 2= hypertrophic Wound distortion score 0= no distortion score 1= slight distortion score 2= obvious distortion The total of the scores in the three categories indicates the wound healing score, the total score ranges from 0 to 6, with lower scores indicating better healing.

Secondary Outcome Measures

Name	Time	Method
Patient's quality of life	1-month follow-up after gingivectomy and gingiplasty	The effect of ozone therapy on wound healing after gingivectomy and gingivoplasty surgery will be measured at 1-month follow-up using a visual analog scale on patient quality of life.

Trial Locations

Locations (1)

Kütahya Health Sciences University Faculty of Dentistry; 🇹🇷 Kutahya, Turkey