Wound Healing After Gingivectomy (OZONE-GING)

April 1, 2026 updated by: Alparslan Dilsiz, Ataturk University

The Effect of Adjunctive Gaseous Ozone Therapy on Wound Healing After Gingivectomy/Gingivoplasty in Patients With Chronic Inflammatory Gingival Enlargement: A Randomized Split-Mouth Clinical Trial

Gingival enlargement caused by chronic inflammation may require surgical intervention when non-surgical periodontal therapy is insufficient. Gingivectomy and gingivoplasty are commonly performed procedures to remove excessive gingival tissue and restore normal gingival contour. However, postoperative wound healing may be affected by factors such as microbial contamination and the inflammatory response.

Medical ozone therapy has antimicrobial, anti-inflammatory, and biostimulatory properties that may enhance tissue regeneration and accelerate wound healing. The aim of this randomized split-mouth clinical trial is to evaluate the effect of adjunctive gaseous ozone therapy on wound healing following gingivectomy/gingivoplasty in individuals with chronic inflammatory gingival enlargement.

Twenty-four systemically healthy participants diagnosed with chronic inflammatory gingival enlargement will be included. Surgical sites will be randomly assigned in a split-mouth design to either the test group (gingivectomy/gingivoplasty with adjunctive gaseous ozone application) or the control group (gingivectomy/gingivoplasty alone).

Clinical periodontal parameters (Plaque Index, Gingival Index, Bleeding on Probing, Probing Pocket Depth, and Clinical Attachment Level) will be assessed at baseline and post-operative Day 21. Histopathological outcomes (Superficial Cell Index and Keratinization Index) will be evaluated at baseline and on post-operative Days 1, 3, 7, and 21.

The results of this study are expected to provide clinical and histopathological evidence regarding the potential benefits of adjunctive ozone therapy in periodontal wound healing.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Chronic inflammatory gingival enlargement is a condition characterized by an increase in gingival volume due to inflammatory changes associated with dental plaque. Non-surgical periodontal therapy is the primary treatment approach; however, in some cases, surgical intervention such as gingivectomy or gingivoplasty is required to eliminate excess gingival tissue and restore gingival architecture.

Gingivectomy/gingivoplasty creates a surgical wound surface that is exposed to the oral environment and microbial flora. Therefore, the healing process may be influenced by several biological and environmental factors. Adjunctive therapeutic approaches that enhance wound healing and reduce microbial contamination may improve clinical outcomes following periodontal surgery.

Medical ozone therapy, consisting of a controlled mixture of oxygen (O₂) and ozone (O₃), has antimicrobial, anti-inflammatory, and immunomodulatory properties. It has also been suggested to stimulate fibroblast activity, enhance tissue oxygenation, and promote growth factor release, potentially accelerating tissue regeneration and wound healing.

The present study is designed as a single-center, randomized, split-mouth clinical trial with blinded outcome assessment to investigate the effect of adjunctive gaseous ozone therapy on wound healing following gingivectomy/gingivoplasty in patients with chronic inflammatory gingival enlargement.

A total of 24 systemically healthy individuals aged between 18 and 40 years diagnosed with chronic inflammatory gingival enlargement will be included. Following non-surgical periodontal therapy and oral hygiene instruction, gingivectomy/gingivoplasty will be performed under local anesthesia. Surgical sites will be randomly assigned using a coin-toss method in a split-mouth design to either the test group (gingivectomy/gingivoplasty with adjunctive gaseous ozone application) or the control group (gingivectomy/gingivoplasty alone).

In the test group, gaseous ozone will be applied to the surgical wound area using a dedicated probe for one minute per tooth according to the manufacturer's instructions. Ozone application will be repeated at 24 hours and on post-operative Day 3.

Clinical periodontal parameters (Plaque Index [PI], Gingival Index [GI], Bleeding on Probing [BOP], Probing Pocket Depth [PPD], and Clinical Attachment Level [CAL]) will be assessed at baseline and on post-operative Day 21.

Exfoliative cytology samples will be obtained from the wound area at baseline and on post-operative Days 1, 3, 7, and 21. Histopathological evaluation will be performed to determine the Superficial Cell Index (SCI) and Keratinization Index (KI), which are indicators of epithelial maturation and wound healing.

The findings of this study are expected to provide clinical and histopathological evidence regarding the potential benefits of adjunctive ozone therapy in periodontal wound healing and may support its use as an adjunctive treatment in periodontal surgical procedures.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
      • Erzurum, Turkey (Türkiye)
        • Ataturk University Faculty of Dentistry, Department of Periodontology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Systemically healthy individuals
  • Patients diagnosed with chronic inflammatory gingival enlargement
  • Presence of gingival enlargement affecting the maxillary or mandibular anterior region
  • Symmetrical involvement of at least six teeth
  • No clinical attachment loss
  • Ability to maintain adequate oral hygiene following non-surgical periodontal therapy
  • No pregnancy or lactation

Exclusion Criteria:

  • Presence of systemic diseases that may affect wound healing
  • Current orthodontic treatment
  • Smoking or alcohol use
  • Use of medications affecting periodontal tissues within the last two months
  • Inability to maintain adequate oral hygiene

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ozone Group
Participants receive gingivectomy/gingivoplasty followed by adjunctive gaseous ozone application.
Procedure: Gaseous ozone application
Gaseous ozone is applied to the surgical wound area using an ozone delivery probe for 1 minute per tooth following gingivectomy/gingivoplasty. The application is repeated at 24 hours and on post-operative Day 3.
Procedure: Gingivectomy/gingivoplasty
Gingivectomy/gingivoplasty is performed under local anesthesia without any additional adjunctive treatment.
Active Comparator: Control Group
Participants receive gingivectomy/gingivoplasty without adjunctive ozone therapy.
Procedure: Gingivectomy/gingivoplasty
Gingivectomy/gingivoplasty is performed under local anesthesia without any additional adjunctive treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Superficial Cell Index (SCI)
Time Frame: Baseline, and post-operative Days 1, 3, 7, and 21
Evaluation of epithelial cell maturation and wound healing using exfoliative cytology based on the analysis of at least 200 cells per smear.
Baseline, and post-operative Days 1, 3, 7, and 21
Keratinization Index (KI)
Time Frame: Baseline, and post-operative Days 1, 3, 7, and 21
Assessment of epithelial keratinization during the wound healing process using exfoliative cytology.
Baseline, and post-operative Days 1, 3, 7, and 21

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plaque Index (PI)
Time Frame: Baseline and post-operative Day 21
Measurement of dental plaque accumulation.
Baseline and post-operative Day 21
Gingival Index (GI)
Time Frame: Baseline and post-operative Day 21
Assessment of gingival inflammation severity.
Baseline and post-operative Day 21
Bleeding on Probing (BOP)
Time Frame: Baseline and post-operative Day 21
Evaluation of gingival bleeding following periodontal probing.
Baseline and post-operative Day 21
Probing Pocket Depth (PPD)
Time Frame: Baseline and post-operative Day 21
Measurement of periodontal pocket depth in millimeters.
Baseline and post-operative Day 21
Clinical Attachment Level (CAL)
Time Frame: Baseline and post-operative Day 21
Assessment of periodontal attachment level in millimeters.
Baseline and post-operative Day 21

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ataturk University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 20, 2026

Primary Completion (Actual)

February 20, 2026

Study Completion (Actual)

March 10, 2026

Study Registration Dates

First Submitted

March 14, 2026

First Submitted That Met QC Criteria

April 1, 2026

First Posted (Actual)

April 8, 2026

Study Record Updates

Last Update Posted (Actual)

April 8, 2026

Last Update Submitted That Met QC Criteria

April 1, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ATAUNI-PERIO-OZONE-2026
  • PN-2026/06 (Other Identifier: Ataturk University Scientific Research Projects Unit (BAP))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD) will not be publicly shared due to privacy and confidentiality concerns related to participant information. However, de-identified data may be made available from the corresponding author upon reasonable request for scientific purposes.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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