Efficacy of Hypochlorous Acid as a Postoperative Wound Antiseptic

NCT06760403 | Completed

• 1 other identifier: MCT4
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Wound Healing

Keywords

gingival overgrowth; gingivoplasty; gingivectomy; hypochlorous acid; chlorhexidine

Outcome Measures

Primary Outcomes (9)

• Plaque index

  The amount of plaque was scored.

  Baseline, Day 7

• Gingival index

  The gingival status was scored.

  Baseline, Day 7

• Probing depth

  The periodontal pocket depth was performed (mm).

  Baseline, Day 7

• Clinical attachment level

  The clinical attachment level was measured (mm).

  Baseline, Day 7

• Bleeding on probing

  The gingival status was scored.(%)

  Baseline, Day 7

• Epithelialization with plaque staining agent

  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

  The wound surface epithelialization was observed with H2O2. Scored as foaming present/absent after application with H2O2

  Day 3 and 7

• Histological analysis

  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)

  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

Study Arms (3)

Hypochlorous Group

EXPERIMENTAL

In the hypochlorous acid group, 15 ml was used as a postoperative gargle, 2 times \* 7 days.

Drug: Hypochlorous acid

Chlorhexidine Group

ACTIVE COMPARATOR

In the clorhexidine group, 15 ml was used as a postoperative gargle, 2 times \* 7 days.

Drug: Hypochlorous acid

Saline Group

PLACEBO COMPARATOR

In the saline group, 15 ml was used as a postoperative gargle, 2 times \* 7 days.

Drug: Hypochlorous acid

Interventions

Hypochlorous acid DRUG

Hypochlorous acid, chlorhexidine and saline groups were compared as postoperative gargles after gingivectomy surgery.

Chlorhexidine Group; Hypochlorous Group; Saline Group

Eligibility Criteria

• Age: 12 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Gingival overgrowth affecting at least six teeth symmetrically in the mandibular or maxillary anterior area
• No attachment and bone loss
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ataturk University: lead

Study Sites (1)

Atatürk University Faculty of Dentistry

Erzurum, 25240, Turkey (Türkiye)

Location

Related Publications (1)

• Burian EA, Sabah L, Kirketerp-Moller K, Gundersen G, Agren MS. Effect of Stabilized Hypochlorous Acid on Re-epithelialization and Bacterial Bioburden in Acute Wounds: A Randomized Controlled Trial in Healthy Volunteers. Acta Derm Venereol. 2022 May 31;102:adv00727. doi: 10.2340/actadv.v102.1624.

  PMID: 35578822 BACKGROUND

MeSH Terms

Conditions

Gingival Overgrowth

Interventions

Hypochlorous Acid

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Acids, Noncarboxylic; Acids; Inorganic Chemicals; Chlorine Compounds; Reactive Oxygen Species; Free Radicals; Oxides; Oxygen Compounds

Study Officials

• Sema Nur Sevinç Gül, Dr.

  Ataturk University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The study included 24 systemically healthy individuals who were randomly divided into three groups: 1) Hypochlorous acid, 2) Chlorhexidine, and 3) Saline.

Study Record Dates

• First Submitted: December 24, 2024
• First Posted: January 6, 2025
• Study Start: May 2, 2023
• Primary Completion: October 2, 2023
• Study Completion: December 1, 2023
• Last Updated: January 6, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)