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Enrolling by Invitation

NCT Number: NCT06920485

Effect of Hypochlorous Acid-containing Mouthwash on Healing After Impacted Wisdom Tooth Surgery

INTRODUCTION: Local chemotherapeutic agents are used to reduce inflammation after impacted tooth extraction and to minimize possible complications, as well as to increase patient comfort. The aim of this study is to compare the clinical and microbiological effects of different mouthwashes/mouth rinses/antiseptic agents applied after impacted surgical tooth extraction in patients with impacted mandibular third molars within the scope of pain, wound healing and total bacterial load criteria; postoperative complications and healing process.

MATERIAL AND METHODS: According to the Pell and Gregory classification, 96 volunteer patients with unilateral or bilateral Class 2 position A and B impacted mandibular third molars, being systemically healthy (ASA class 1), being between the ages of 18-45/young adult will participate in the study. The patients will be divided into 3 groups: Group 1, Patients who will be administered hypochlorous acid-containing mouthwash in addition to standard treatment after mandibular third molar surgery; Group 2, Patients who will be administered chlorhexidine gluconate-containing mouthwash in addition to standard treatment after mandibular third molar surgery; Group 3, Patients who will be administered sterile saline-containing mouthwash in addition to standard treatment after mandibular third molar surgery. Demographic data before the surgical procedure will be recorded in the patient follow-up form (Appendix-1). As a standard postoperative approach, all patients will be prescribed antibiotics (875 mg Amoxicillin+125 mg clavulonic acid, Augmentin-BID film-coated tablets, GlaxoSmithKline, Istanbul, Turkey), analgesics for use after surgery, and mouthwashes will be given depending on the groups. Patients will be asked to take antibiotics in the morning and evening for 5 days, use mouthwash for 7 days starting from the day after the procedure, and use mouthwash only when deemed necessary, and will be asked to record the amount they use on the home assessment form (ANNEX-2). All patients will be evaluated on the 7th day after the operation, and suture samples will be taken for microbiological load determination. All evaluations will be made before the operation and on the 7th day after the operation; and will be recorded on the patient assessment form (ANNEX-1). First of all, demographic information including age, gender, education level and the operation area will be recorded for all patients. Two separate forms with VAS scales for pain will be given to patients to mark every day for 7 days after the extraction. The patient will be asked to mark the level of pain they feel on the scale. The amount of analgesic use in the home assessment form will also be recorded within the scope of the pain assessment. Healing in the wound area will also be evaluated on the 7th day.

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Key information

Conditions

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Health Sciences University

Ankara, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Having a mandibular third molar with a unilateral or bilateral Class 2, Position A or B impaction according to the Pell and Gregory classification
  • Being systemically healthy (ASA Class I)
  • Aged between 18 and 45 years (young adult age group)
  • Willingness to participate in the study

Exclusion criteria

  • Age outside the specified range
  • Pregnancy
  • Currently breastfeeding
  • Presence of infection in the third molar region (e.g., acute pericoronitis)
  • Presence of cystic or tumoral lesions associated with the impacted third molar
  • History of allergic reactions
  • Presence of any systemic disease
  • Unwillingness to participate in the study
  • Poor oral hygiene that may negatively affect healing
  • Smoking or alcohol addiction
  • Use of antibiotics or mouthwash in the last three months

Treatment and study plan

Third molar surgery

Procedure

Effects of different gargles/mouth rinses/antiseptic agents applied after impacted surgical tooth extraction on postoperative wound healing and total bacterial load

Pain Medicine

Diagnostic Test

After the extraction, patients will be given two separate forms with VAS scales for pain to mark every day for 7 days. The patient will be asked to mark the level of pain they feel on the scale. The amount of analgesic use on the home assessment form will also be recorded as part of the pain assessment. On the 7th day, healing in the wound area will also be assessed.

Wound healing

Diagnostic Test

The degree of healing of the wound area will be checked using Landry scoring.

Total bacterial load

Other

Total bacterial load will be evaluated by microbiological analysis of sutures obtained from all groups.

Primary outcomes

  1. Change in pain levels after mandibular third molar surgery

    Time frame: From postoperative day 1 to day 7

    Pain levels will be assessed daily for 7 days following mandibular third molar surgery using the Visual Analog Scale (VAS), a 10-centimeter scale ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater pain intensity. Patients will complete the VAS form daily, and the average score across the 7-day period will be calculated for each participant.

    Unit of Measure: Visual Analog Scale score (0-10)

  2. Total bacterial load on suture materials evaluated by qPCR

    Time frame: Postoperative day 7

    On postoperative day 7, suture materials will be collected from each participant. DNA will be isolated using a commercial extraction kit, and real-time polymerase chain reaction (qPCR) targeting the 16S ribosomal RNA (rRNA) gene will be performed to quantify total bacterial DNA. Results will be expressed as the number of 16S rRNA gene copies per sample.

    Unit of Measure: Copies of 16S rRNA gene per sample

  3. Wound healing status on postoperative day 7

    Time frame: Postoperative day 7

    The surgical site will be clinically evaluated for wound healing on day 7 after surgery using a standardized Early Wound Healing Index (EHI), which assesses clinical signs such as redness, swelling, bleeding, and epithelialization. The EHI is scored on a scale from 0 to 5, where 0 indicates very poor healing and 5 indicates excellent healing. Higher scores reflect better healing outcomes.

    Unit of Measure: Early Wound Healing Index score (0-5)

Secondary outcomes

  1. Number of analgesic tablets consumed postoperatively

    Time frame: From postoperative day 1 to day 7

    Participants will record the number of analgesic tablets taken each day for 7 days after surgery in a home diary. The total number of tablets consumed will be calculated. Unit of Measure: Number of tablets per patient

Sponsors and collaborators

Lead sponsor

Saglik Bilimleri Universitesi

Other

Registry information

Official study title

Clinical and Microbiological Evaluation of the Effects of Hypochlorous Acid Mouthwash Use in the Postoperative Period of Mandibular Third Molar Tooth Extractions

Acronym: Mouthwash

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Apr 9, 2025
Registry last updated
Apr 16, 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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