The Effect of Ozone Therapy on Gingivoplasty

Evaluation of the Effect of Ozone Therapy Application on Wound Healing After Gingivoplasty

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

Study Overview

• Status: Recruiting
• Conditions: Gingival Enlargement
• Intervention / Treatment: Procedure: Gingivectomy and gingivoplasty surgery and periodontal paste +ozone therapy application; Procedure: Gingivectomy and gingivoplasty surgery and periodontal paste application

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 Type: Interventional
• Enrollment (Estimated): 48
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Seyma Eken; Phone Number: 05518489820; Email: seyma.eken@ksbu.edu.tr
• Study Contact Backup: Name: Berceste Güler Ayyıldız; Phone Number: +05059359207; Email: berceste.guler@ksbu.edu.tr

Study Locations

• Turkey (Türkiye)
  • Kütahya, Turkey (Türkiye), 43100
    • Recruiting
    • Kütahya Health Sciences University Faculty of Dentistry
    • Contact: Berceste Guler Ayyıldız, Assoc. Prof.; Phone Number: 05518489820; Email: seymek.91@gmail.com
    • Contact: Seyma Eken, Lect. Dr.; Phone Number: 05518489820; Email: seymek.91@gmail.com
    • Principal Investigator: Berceste Guler Ayyıldız, Assoc. Prof.
    • Sub-Investigator: Seyma Eken, Lect. Dr
    • Sub-Investigator: Ahu Uraz Corekci, Prof.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Test group; Periodontal paste application (Coe-pak) using active oxygen (Cure 09 Active Oxygen) on the wound surface after gingivectomy and gingivoplasty surgery applied to the maxillary anterior regions	Procedure: Gingivectomy and gingivoplasty surgery and periodontal paste +ozone therapy application; After taking systemic and dental anamnesis from all patients, Phase 1 periodontal treatment will be performed and oral hygiene education will be given. Patients will be called 4 weeks after treatment for re-evaluation and surgical treatment will be planned. 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 bevel incision will be made along the determined incision line with a number 15 scalpel. After the incision is completed, the remaining tissues will be removed using microsurgical scissors. Then gingivoplasty will be performed. After gingivectomy and gingivoplasty, the surgical site will be left for secondary healing. Periodontal paste (Coe-pak) will be applied to the area left for secondary healing after ozone therapy (activated oxygen (Cure 09 Active Oxygen))
Other: Control group; Only periodontal paste application (Coe-pak) to the wound surface after gingivectomy and gingivoplasty surgery applied to the maxillary anterior regions	Procedure: Gingivectomy and gingivoplasty surgery and periodontal paste application; After taking systemic and dental anamnesis from all patients, Phase 1 periodontal treatment will be performed and oral hygiene education will be given. Patients will be called 4 weeks after treatment for re-evaluation and surgical treatment will be planned. 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 bevel incision will be made along the determined incision line with a number 15 scalpel. After the incision is completed, the remaining tissues will be removed using microsurgical scissors. Then gingivoplasty will be performed. After gingivectomy and gingivoplasty, the surgical site will be left for secondary healing. Only periodontal paste will be applied after the surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gingival inflammation	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,; mild inflammation,; moderate inflammation,; severe inflammation	1-month follow-up after gingivectomy and gingivoplasty surgery
Gingival contour	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.	1-month follow-up after gingivectomy and gingiplasty
Re-epithelialisation evaluation	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.	1-month follow-up after gingivectomy and gingivoplasty surgery
Gingival distortion	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.	1-month follow-up after gingivectomy and gingiplasty

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient's quality of life	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.	1-month follow-up after gingivectomy and gingiplasty

Collaborators and Investigators

• Sponsor: Kutahya Health Sciences University
• Investigators: Study Director: Berceste Güler Ayyıldız, Assoc. Prof., Kutahya Health Sciences University

Publications and helpful links

General Publications

• Uslu MO, Akgul S. Evaluation of the effects of photobiomodulation therapy and ozone applications after gingivectomy and gingivoplasty on postoperative pain and patients' oral health-related quality of life. Lasers Med Sci. 2020 Sep;35(7):1637-1647. doi: 10.1007/s10103-020-03037-8. Epub 2020 May 20.
• Gupta G, Mansi B. Ozone therapy in periodontics. J Med Life. 2012 Feb 22;5(1):59-67. Epub 2012 Mar 5.
• Eroglu ZT, Kurtis B, Altug HA, Sahin S, Tuter G, Baris E. Effect of topical ozonetherapy on gingival wound healing in pigs: histological and immuno-histochemical analysis. J Appl Oral Sci. 2018 Dec 10;27:e20180015. doi: 10.1590/1678-7757-2018-0015.
• Chesterman J, Beaumont J, Kellett M, Durey K. Gingival overgrowth: Part 2: management strategies. Br Dent J. 2017 Feb 10;222(3):159-165. doi: 10.1038/sj.bdj.2017.111.
• Bozkurt E, Uslu MO. Evaluation of the effects of platelet-rich fibrin, concentrated growth factors, and autologous fibrin glue application on wound healing following gingivectomy and gingivoplasty operations: a randomized controlled clinical trial. Quintessence Int. 2022 Mar 14;53(4):328-341. doi: 10.3290/j.qi.b2449819.
• Kusakci-Seker B, Demirayak-Akdemir M. The effect of non-thermal atmospheric pressure plasma application on wound healing after gingivectomy. Int Wound J. 2020 Oct;17(5):1376-1383. doi: 10.1111/iwj.13379. Epub 2020 May 27.
• Beaumont J, Chesterman J, Kellett M, Durey K. Gingival overgrowth: Part 1: aetiology and clinical diagnosis. Br Dent J. 2017 Jan 27;222(2):85-91. doi: 10.1038/sj.bdj.2017.71.

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2022
• Primary Completion (Estimated): December 15, 2025
• Study Completion (Estimated): April 15, 2026

Study Registration Dates

• First Submitted: November 27, 2024
• First Submitted That Met QC Criteria: December 20, 2024
• First Posted (Actual): December 31, 2024

Study Record Updates

• Last Update Posted (Estimated): September 5, 2025
• Last Update Submitted That Met QC Criteria: September 4, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Wound healing; Gingivectomy; Gingivoplasty; Ozone therapy; Gingival enlargement
• Additional Relevant MeSH Terms: Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Gingival Diseases; Gingival Overgrowth; Surgical Procedures, Operative; Dentistry; Oral Surgical Procedures; Periodontics; Gingivectomy
• Other Study ID Numbers: 2022-15/01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Study Protocol

Statistical Analysis Plan (SAP)

• IPD Sharing Time Frame: The work will be shared 6 months after publication
• IPD Sharing Access Criteria: It will be shared in case the principal investigator is contacted.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No