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Completed

NCT Number: NCT07517328

Wound Healing After Gingivectomy

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.

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Key information

Age range

15 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ataturk University Faculty of Dentistry, Department of Periodontology

Erzurum, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gaseous Ozone Application

Procedure

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.

Gingivectomy/gingivoplasty

Procedure

Gingivectomy/gingivoplasty is performed under local anesthesia without any additional adjunctive treatment.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Plaque Index (PI)

    Time frame: Baseline and post-operative Day 21

    Measurement of dental plaque accumulation.

  2. Gingival Index (GI)

    Time frame: Baseline and post-operative Day 21

    Assessment of gingival inflammation severity.

  3. Bleeding on Probing (BOP)

    Time frame: Baseline and post-operative Day 21

    Evaluation of gingival bleeding following periodontal probing.

  4. Probing Pocket Depth (PPD)

    Time frame: Baseline and post-operative Day 21

    Measurement of periodontal pocket depth in millimeters.

  5. Clinical Attachment Level (CAL)

    Time frame: Baseline and post-operative Day 21

    Assessment of periodontal attachment level in millimeters.

Sponsors and collaborators

Lead sponsor

Ataturk University

Other

Registry information

Official study title

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

Acronym: OZONE-GING

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 8, 2026
Registry last updated
Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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