The Effect of Ozone Therapy on Gingivoplasty

NCT06753305 | Recruiting

• 1 other identifier: 2022-15/01
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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

Conditions

Gingival Enlargement

Keywords

Gingival enlargement; Ozone therapy; Wound healing; Gingivectomy; Gingivoplasty

Outcome Measures

Primary Outcomes (4)

• 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, 1. mild inflammation, 2. moderate inflammation, 3. 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 Outcomes (1)

• Patient's quality of life

  1-month follow-up after gingivectomy and gingiplasty

Study Arms (2)

Test group

OTHER

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

Control group

OTHER

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

Interventions

Gingivectomy and gingivoplasty surgery and periodontal paste +ozone therapy application PROCEDURE

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))

Test group

Gingivectomy and gingivoplasty surgery and periodontal paste application PROCEDURE

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.

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Pregnancy
• Hereditary gingival fibromatosis
• Drug-induced gingival enlargement
• Allergy
• Presence of systemic conditions requiring antibiotic prophylaxis
• Acute and untreated periodontitis

Sponsors & Collaborators

• Kutahya Health Sciences University: lead

Study Sites (1)

Kütahya Health Sciences University Faculty of Dentistry

Kütahya, 43100, Turkey (Türkiye)

RECRUITING

Related Publications (7)

• 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.

  PMID: 32435906 BACKGROUND

• Gupta G, Mansi B. Ozone therapy in periodontics. J Med Life. 2012 Feb 22;5(1):59-67. Epub 2012 Mar 5.

  PMID: 22574088 BACKGROUND

• 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.

  PMID: 30540068 BACKGROUND

• 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.

  PMID: 28184072 BACKGROUND

• 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.

  PMID: 34927405 BACKGROUND

• 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.

  PMID: 32462820 BACKGROUND

• 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.

  PMID: 28127024 BACKGROUND

MeSH Terms

Conditions

Gingival Hyperplasia

Interventions

Gingivectomy

Condition Hierarchy (Ancestors)

Gingival Overgrowth; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Oral Surgical Procedures; Surgical Procedures, Operative; Dentistry; Periodontics

Study Officials

• Berceste Güler Ayyıldız, Assoc. Prof.

  Kütahya Health Sciences University

  STUDY DIRECTOR

Central Study Contacts

Berceste Güler Ayyıldız

CONTACT

+05059359207; berceste.guler@ksbu.edu.tr

Seyma Eken

CONTACT

05518489820; seyma.eken@ksbu.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof. Dr.

Model Details: 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. Patients will be evaluated in two different groups as test and control group after surgery. Patients will be randomly allocated to the study groups by closed envelope method. The test group will receive periodontal paste (Coe-pak) + Ozone therapy (activated oxygen (Cure 09 Active Oxygen)) following gingivectomy and gingivoplasty surgery, while the control group will receive only periodontal paste application following gingivectomy and gingivoplasty surgery. All patients will undergo gingivectomy and gingivoplasty with the same procedure.

Study Record Dates

• First Submitted: November 27, 2024
• First Posted: December 31, 2024
• Study Start: November 15, 2022
• Primary Completion: December 15, 2025
• Study Completion: April 15, 2026
• Last Updated: September 5, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: The work will be shared 6 months after publication
• Access Criteria: It will be shared in case the principal investigator is contacted.

Locations

TU (1)