NCT07517328

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 20, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2026

Completed
18 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2026

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

March 14, 2026

Completed
25 days until next milestone

First Posted

Study publicly available on registry

April 8, 2026

Completed
Last Updated

April 8, 2026

Status Verified

April 1, 2026

Enrollment Period

1 month

First QC Date

March 14, 2026

Last Update Submit

April 1, 2026

Conditions

Chronic Inflammatory Gingival EnlargementGingival EnlargementGingival Hyperplasia

Keywords

Ozone TherapyGingivectomyWound HealingPeriodontal SurgerySuperficial Cell IndexSplit-Mouth Clinical Trial

Outcome Measures

Primary Outcomes (2)

  • Superficial Cell Index (SCI)

    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)

    Assessment of epithelial keratinization during the wound healing process using exfoliative cytology.

    Baseline, and post-operative Days 1, 3, 7, and 21

Secondary Outcomes (5)

  • Plaque Index (PI)

    Baseline and post-operative Day 21

  • Gingival Index (GI)

    Baseline and post-operative Day 21

  • Bleeding on Probing (BOP)

    Baseline and post-operative Day 21

  • Probing Pocket Depth (PPD)

    Baseline and post-operative Day 21

  • Clinical Attachment Level (CAL)

    Baseline and post-operative Day 21

Study Arms (2)

Ozone Group

EXPERIMENTAL

Participants receive gingivectomy/gingivoplasty followed by adjunctive gaseous ozone application.

Procedure: Gaseous ozone applicationProcedure: Gingivectomy/gingivoplasty

Control Group

ACTIVE COMPARATOR

Participants receive gingivectomy/gingivoplasty without adjunctive ozone therapy.

Procedure: Gingivectomy/gingivoplasty

Interventions

Gaseous ozone applicationPROCEDURE

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.

Ozone Group
Gingivectomy/gingivoplastyPROCEDURE

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

Control GroupOzone Group

Eligibility Criteria

Age15 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ataturk University Faculty of Dentistry, Department of Periodontology

Erzurum, Turkey (Türkiye)

Location

Related Publications (1)

  • Abdul NS, Almughaiseeb AA, Alghannam SM, Alshaikh AB. Unlocking Healing: Ozone Therapy's Breakthrough in Oral Lesion Management - A Narrative Review. J Pharm Bioallied Sci. 2025 Jun;17(Suppl 2):S1076-S1079. doi: 10.4103/jpbs.jpbs_292_25. Epub 2025 Jun 18.

    PMID: 40655745RESULT

MeSH Terms

Conditions

Gingival Hyperplasia

Interventions

GingivectomyGingivoplasty

Condition Hierarchy (Ancestors)

Gingival OvergrowthGingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Oral Surgical ProceduresSurgical Procedures, OperativeDentistryPeriodontics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
This study was designed as a double-blind clinical trial. Participants and outcome assessors were blinded to the treatment allocation. Histopathological evaluation and statistical analyses were performed by investigators who were unaware of group assignments.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This study uses a randomized split-mouth design. Surgical sites within the same participant are randomly assigned to either the test group (gingivectomy/gingivoplasty with adjunctive gaseous ozone application) or the control group (gingivectomy/gingivoplasty alone).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Department of Periodontology, Faculty of Dentistry

Study Record Dates

First Submitted

March 14, 2026

First Posted

April 8, 2026

Study Start

January 20, 2026

Primary Completion

February 20, 2026

Study Completion

March 10, 2026

Last Updated

April 8, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

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.

Locations

TU(1)