Efficacy of Hypochlorous Acid as a Postoperative Wound Antiseptic

NCT ID: NCT06760403

Last Updated: 2025-01-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-02

Study Completion Date

2023-12-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Wound Healing

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Hypochlorous Group

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

Group Type EXPERIMENTAL

Hypochlorous acid

Intervention Type DRUG

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

Chlorhexidine Group

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

Group Type ACTIVE_COMPARATOR

Hypochlorous acid

Intervention Type DRUG

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

Saline Group

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

Group Type PLACEBO_COMPARATOR

Hypochlorous acid

Intervention Type DRUG

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

Interventions

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Hypochlorous acid

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ataturk University

OTHER

Sponsor Role lead

Responsible Party

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Sema Nur Sevinc

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sema Nur Sevinç Gül, Dr.

Role: PRINCIPAL_INVESTIGATOR

Ataturk University

Locations

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Atatürk University Faculty of Dentistry

Erzurum, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 35578822 (View on PubMed)

Other Identifiers

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MCT4

Identifier Type: -

Identifier Source: org_study_id

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