NCT07234994

Brief Summary

The goal of this clinical trial is to compare the effect of photobiomodulation to ozonized gel on wound healing following gingivectomy procedure on adults. The main questions it aims to answer are: Which treatment modality provides less painful and more efficient wound healing ? What are the patient's feedback on different treatment modalities ? Researchers will compare ozonized gel to photobiomodulation to normal gingivectomy procedure with no interference. Participants will: Receive either ozonized gel or photobiomodualtion treatment following surgical gingivectomy Visit the clinic every 3,7,14 and 28 days for checkups and investigations

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 16, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

November 16, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 19, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2026

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2026

Completed
Last Updated

March 3, 2026

Status Verified

November 1, 2025

Enrollment Period

4 months

First QC Date

November 16, 2025

Last Update Submit

March 1, 2026

Conditions

Gingival Enlargement

Keywords

Ozonized gelPhotobiomodulation TherapySurgical gingivectomyWound healing

Outcome Measures

Primary Outcomes (3)

  • Healing index (HI) using Landry index

    The healing index (HI) scores will be assessed on the basis of redness, presence of granulation tissues, bleeding, suppuration, and epithelialization.

    day 3,7,14,28 post surgical gingivectomy

  • Evaluation of epithelialization of the wound area

    A plaque disclosing agent is used to measure wound area epithelialization by dying the abraded and deepithelialized areas on the gingiva on postoperative days 3,7,14 and 28. By using this solution, assessment of degree of epithelialization and wound healing is made easier. Wound surface epithelialization in the obtaining photographs will be evaluated using an Image-analyzing software. To ensure standardization, all photographs will taken by the same person with the same camera at the same angle.

    days 0,3,7,14,28 post surgical gingivectomy

  • Postoperative pain using the VAS

    Visual Analogue Scale (VAS) is a simple measurement tool that measures the intensity of pain as recorded by the patient. 10-point visual analog scale of pain rating, with 0 marked as "no pain" and 10 marked as "worst pain imaginable

    day 0. day 3, day 7, and day 14 post surgery.

Study Arms (3)

Ozonized gel group

ACTIVE COMPARATOR

Application of ozonized gel to raw wound area following surgical gingivectomy.

Drug: ozonized gel application

Photobiomodulation therapy group

ACTIVE COMPARATOR

Application of diode laser 635nm to wound area following surgical gingivectomy

Device: photobiomodulation therapy using diode laser

Control group

NO INTERVENTION

Spontaneous healing of wound area following surgical gingivectomy

Interventions

ozonized gel applicationDRUG

Application of ozonized gel to raw wound area following surgical gingivectomy.

Ozonized gel group
photobiomodulation therapy using diode laserDEVICE

Application of diode laser 635nm to wound area following surgical gingivectomy

Photobiomodulation therapy group

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients indicated for surgical gingivectomy.
  • Adequate amount of keratinized tissue.
  • Average age between 18-40 years.
  • Well-educated patients as post-operative instructions need to be followed precisely.
  • Good oral hygiene with a full mouth O'Leary plaque index of less than or equal to 10% and a full mouth Gingival Index of zero

You may not qualify if:

  • History of smoking.
  • Patients who have any known systemic disease that interfere with performance of surgical gingivectomy or periodontal wound healing.
  • Patients who have any previous adverse reactions to the products (or similar products) used in this study.
  • Pregnant women.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry, Alexandria University

Alexandria, 5310002, Egypt

RECRUITING

MeSH Terms

Conditions

Gingival Hyperplasia

Condition Hierarchy (Ancestors)

Gingival OvergrowthGingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dentist

Study Record Dates

First Submitted

November 16, 2025

First Posted

November 19, 2025

Study Start

November 16, 2025

Primary Completion

March 15, 2026

Study Completion

March 30, 2026

Last Updated

March 3, 2026

Record last verified: 2025-11

Locations

EG(1)