Clinical trial NCT06760403: Efficacy of Hypochlorous Acid as a Postoperative Wound Antiseptic
Official title: Investigation of the Efficacy of Hypochlorous Acid as a Postoperative Wound Antiseptic: A Randomized Controlled Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wound Healing
Keywords: gingival overgrowth
gingivoplasty
gingivectomy
hypochlorous acid
chlorhexidine
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2025-01-06
Enrollment: 24
Sex: ALL
Minimum age (years): 12
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study included 24 systemically healthy individuals who were randomly divided into three groups: 1) Hypochlorous acid, 2) Chlorhexidine, and 3) Saline.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Plaque index
timeFrame: Baseline, Day 7
measure: Gingival index
timeFrame: Baseline, Day 7
measure: Probing depth
timeFrame: Baseline, Day 7
measure: Clinical attachment level
timeFrame: Baseline, Day 7
measure: Bleeding on probing
timeFrame: Baseline, Day 7
measure: Epithelialization with plaque staining agent
timeFrame: Day 1, 3, and 7
measure: Epithelialization with H2O2
timeFrame: Day 3 and 7
measure: Histological analysis
timeFrame: Day 1, 3, and 7
measure: postoperative pain with Visiual Analogue Scale (VAS)
timeFrame: Day 3 and 7
Secondary outcomes:
Other outcomes:
Locations:
city: Erzurum
country: Turkey
facility: Atatürk University Faculty of Dentistry
Study officials:
affiliation: Ataturk University
name: Sema Nur Sevinç Gül, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.