The Effect of Ozone Therapy on Gingivoplasty

NCT06753305 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2025-09-05

No results posted yet for this study

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

Interventions

PROCEDURE

Gingivectomy and gingivoplasty surgery and periodontal paste +ozone therapy application

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))

PROCEDURE

Gingivectomy and gingivoplasty surgery and periodontal paste application

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.

Sponsors & Collaborators

  • Kutahya Health Sciences University

    lead OTHER

Principal Investigators

  • Berceste Güler Ayyıldız, Assoc. Prof. · Kütahya Health Sciences University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-15
Primary Completion
2025-12-15
Completion
2026-04-15

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06753305 on ClinicalTrials.gov