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Completed

NCT Number: NCT06760403

Efficacy of Hypochlorous Acid as a Postoperative Wound Antiseptic

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.

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Key information

Conditions

Wound Healing Gingival Diseases Gingival Overgrowth Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

12 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Atatürk University Faculty of Dentistry

Erzurum, 25240, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hypochlorous Acid

Drug

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

Primary outcomes

  1. Plaque index

    Time frame: Baseline, Day 7

    The amount of plaque was scored.

  2. Gingival index

    Time frame: Baseline, Day 7

    The gingival status was scored.

  3. Probing depth

    Time frame: Baseline, Day 7

    The periodontal pocket depth was performed (mm).

  4. Clinical attachment level

    Time frame: Baseline, Day 7

    The clinical attachment level was measured (mm).

  5. Bleeding on probing

    Time frame: Baseline, Day 7

    The gingival status was scored.(%)

  6. 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.

  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

  8. 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.

  9. 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.

Sponsors and collaborators

Lead sponsor

Ataturk University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jan 6, 2025
Registry last updated
Jan 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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