NCT07466992

Brief Summary

Impacted mandibular third molar extraction is one of the most common procedures in oral and maxillofacial surgery and is frequently associated with postoperative complications such as pain, edema, and trismus, which may negatively affect patients' quality of life. Various pharmacological and topical agents have been used to reduce these postoperative complications. Chlorhexidine gluconate mouthwash is widely considered the gold standard antiseptic agent due to its broad antimicrobial activity; however, its use may be associated with adverse effects such as tooth staining and taste alteration. Hypochlorous acid is an alternative antiseptic agent with antimicrobial and anti-inflammatory properties and good tissue compatibility. The aim of this randomized clinical study was to compare the effectiveness of hypochlorous acid mouthwash and chlorhexidine gluconate mouthwash in reducing postoperative complications following impacted mandibular third molar surgery. A total of 43 healthy patients with bilateral impacted mandibular third molars were included in the study. Postoperative outcomes including pain (VAS), edema, trismus, and wound healing were evaluated at specific follow-up intervals. The results were analyzed to determine whether hypochlorous acid could be considered a potential alternative to chlorhexidine in postoperative oral care.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2022

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

March 8, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 12, 2026

Completed
Last Updated

March 12, 2026

Status Verified

March 1, 2026

Enrollment Period

7 months

First QC Date

March 8, 2026

Last Update Submit

March 8, 2026

Conditions

Keywords

impacted third molarhypochlorous acidchlorhexidine gluconate

Outcome Measures

Primary Outcomes (3)

  • Visual Analog Scale (VAS)

    n the pain assessment, the patients were given a VAS form at 3, 6, 12 and 24 hours and on the 2nd, 3rd, 4th, 5th, 6th and 7th days and the pain felt by the patient was marked on this scale. This form consists of numbers between 0 and 10. 0 represents 'no pain at all' and 10 represents 'worst possible pain'.

    3, 6, 12 and 24 hours and the 2nd, 3rd, 4th, 5th, 6th and 7th days

  • Trismus

    In all patients participating in the study, the maximum interincisal distance for trismus was measured and recorded by the same physician before the operation and on the 2nd and 7th days after the operation.

    preop, 2th and 7th days

  • Edema

    For edema, some anatomical points on the face were taken as reference points and the distance between these points was measured with a tape measure and recorded. The angulus point was determined as the center point and the distances between angulus-tragus, angulus-lateral corner of the eye, angulus-nasal base, angulus-labial commissure and angulus-pogonion point were measured.

    preop, 2th and 7th days

Study Arms (2)

chlorhexidine gluconate

ACTIVE COMPARATOR

Patients used chlorhexidine gluconate mouthwash starting 24 hours after surgery, three times daily.

Drug: Hypochlorous AcidDrug: Chlorhexidine Gluconate Mouthwash

Hypochlorous Acid Mouthwash

ACTIVE COMPARATOR

Patients used hypochlorous acid mouthwash starting 24 hours after surgery, three times daily.

Drug: Hypochlorous AcidDrug: Chlorhexidine Gluconate Mouthwash

Interventions

Hypochlorous acid mouthwash is an antimicrobial oral rinse with broad-spectrum activity against bacteria, viruses, and fungi. It is used as a postoperative antiseptic agent to reduce microbial load, inflammation, and the risk of infection following oral surgical procedures.

Hypochlorous Acid Mouthwashchlorhexidine gluconate

Patients used chlorhexidine gluconate mouthwash starting 24 hours after surgery, three times daily.

Hypochlorous Acid Mouthwashchlorhexidine gluconate

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age between 18 and 40 years
  • Presence of bilateral impacted mandibular third molars with similar surgical difficulty
  • Good general health with no systemic disease
  • Ability to comply with postoperative instructions and follow-up visits

You may not qualify if:

  • Presence of systemic disease
  • Pregnancy or breastfeeding
  • Active infection at the surgical site
  • History of allergy to study medications
  • Use of antibiotics or anti-inflammatory drugs within two weeks before surgery
  • Temporomandibular joint disorders causing limited mouth opening

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Van Yüzüncü Yıl Üniversitesi Diş Hekimliği Fakültesi

Van, 65580, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Hypochlorous Acid

Intervention Hierarchy (Ancestors)

Acids, NoncarboxylicAcidsInorganic ChemicalsChlorine CompoundsReactive Oxygen SpeciesFree RadicalsOxidesOxygen Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 8, 2026

First Posted

March 12, 2026

Study Start

December 1, 2021

Primary Completion

July 1, 2022

Study Completion

August 1, 2022

Last Updated

March 12, 2026

Record last verified: 2026-03

Locations