NCT07517328

Wound Healing After Gingivectomy

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Ataturk University · Academic / Other
• Sex: All
• Age: 15 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Chronic Inflammatory Gingival Enlargement
• Gingival Enlargement
• Gingival Hyperplasia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-01-20
• Primary completion: 2026-02-20
• Completion: 2026-03-10
• First posted: 2026-04-08
• Last updated: 2026-04-08

Locations

1 site across 1 country: Turkey (Türkiye)