Efficacy of Hypochlorous Acid as a Postoperative Wound Antiseptic

January 3, 2025 updated by: Sema Nur Sevinc, Ataturk University

Investigation of the Efficacy of Hypochlorous Acid as a Postoperative Wound Antiseptic: A Randomized Controlled Pilot Study

The aim was to examine the effectiveness of hypochlorous acid on postoperative wound healing in 24 systemically healthy gingivectomy participants aged 12-30. The participants were divided into 3 groups as hypochlorous acid group, chlorhexidine group and saline group and their wound healing was evaluated on the 1st, 3rd and 7th days.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The aim of this study was to investigate the effectiveness of hypochlorous acid on postoperative wound healing in 24 participants aged 12-30 who underwent gingivectomy involving the 6 anterior teeth of the upper or lower jaw with chronic inflammatory gingival overgrowth. The participants were divided into 3 groups as hypochlorous acid group, chlorhexidine group and saline group and were called for control on the 1st, 3rd and 7th days to evaluate wound healing. Periodontal indexes, visual analog scale (VAS), H2O2, plaque staining agent test, and histological analyzes were used to evaluate wound healing. The data were analyzed statistically.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Erzurum, Turkey, 25240
        • Atatürk University Faculty of Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Gingival overgrowth affecting at least six teeth symmetrically in the mandibular or maxillary anterior area
  • No attachment and bone loss
  • 7 days before the surgery, full-mouth plaque index (PI) < 25% and a full-mouth gingival bleeding index (GBI) < 25%.
  • the keratinized tissues surrounding the teeth are at least 2 mm wide.

Exclusion Criteria:

  • Smoking or alcohol use
  • Patients who have undergone systemic antimicrobial therapy and surgical procedures within the last 3 months
  • Pregnancy or lactation
  • Immunodeficiency or immunosuppressive drug therapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hypochlorous Group
In the hypochlorous acid group, 15 ml was used as a postoperative gargle, 2 times * 7 days.
Drug: Hypochlorous acid
Hypochlorous acid, chlorhexidine and saline groups were compared as postoperative gargles after gingivectomy surgery.
Active Comparator: Chlorhexidine Group
In the clorhexidine group, 15 ml was used as a postoperative gargle, 2 times * 7 days.
Drug: Hypochlorous acid
Hypochlorous acid, chlorhexidine and saline groups were compared as postoperative gargles after gingivectomy surgery.
Placebo Comparator: Saline Group
In the saline group, 15 ml was used as a postoperative gargle, 2 times * 7 days.
Drug: Hypochlorous acid
Hypochlorous acid, chlorhexidine and saline groups were compared as postoperative gargles after gingivectomy surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plaque index
Time Frame: Baseline, Day 7
The amount of plaque was scored.
Baseline, Day 7
Gingival index
Time Frame: Baseline, Day 7
The gingival status was scored.
Baseline, Day 7
Probing depth
Time Frame: Baseline, Day 7
The periodontal pocket depth was performed (mm).
Baseline, Day 7
Clinical attachment level
Time Frame: Baseline, Day 7
The clinical attachment level was measured (mm).
Baseline, Day 7
Bleeding on probing
Time Frame: Baseline, Day 7
The gingival status was scored.(%)
Baseline, Day 7
Epithelialization with plaque staining agent
Time Frame: Day 1, 3, and 7
The wound surface epithelialization was observed with plaque staining agent. The wound surface was stained with plaque staining dye and the dark colored area is calculated as mm2.
Day 1, 3, and 7
Epithelialization with H2O2
Time Frame: Day 3 and 7
The wound surface epithelialization was observed with H2O2. Scored as foaming present/absent after application with H2O2
Day 3 and 7
Histological analysis
Time Frame: Day 1, 3, and 7
Histological analysis evaluated epithelial keratinization, regeneration, and/or degeneration during the healing process and to obtain epithelial samples repeatedly. The number of keratinocytes was counted.
Day 1, 3, and 7
postoperative pain with Visiual Analogue Scale (VAS)
Time Frame: Day 3 and 7
VAS scores were taken on the 3rd and 7th days without any intervention to the patient. Scored between 1-10 as 1 was no pain, 10 was pain.
Day 3 and 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ataturk University

Investigators

  • Principal Investigator: Sema Nur Sevinç Gül, Dr., Ataturk University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 2, 2023

Primary Completion (Actual)

October 2, 2023

Study Completion (Actual)

December 1, 2023

Study Registration Dates

First Submitted

December 24, 2024

First Submitted That Met QC Criteria

January 3, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 3, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MCT4

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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