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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ataturk University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 2, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 2, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 24, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 3, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 3, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

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