Clinical trial NCT06920485: Effect of Hypochlorous Acid-containing Mouthwash on Healing After Impacted Wisdom Tooth Surgery
Official title: Clinical and Microbiological Evaluation of the Effects of Hypochlorous Acid Mouthwash Use in the Postoperative Period of Mandibular Third Molar Tooth Extractions
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Oral Health
Lead sponsor: Saglik Bilimleri Universitesi
Sponsor class: OTHER
First posted: 2025-04-09
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in pain levels after mandibular third molar surgery
timeFrame: From postoperative day 1 to day 7
measure: Total bacterial load on suture materials evaluated by qPCR
timeFrame: Postoperative day 7
measure: Wound healing status on postoperative day 7
timeFrame: Postoperative day 7
Secondary outcomes:
measure: Number of analgesic tablets consumed postoperatively
timeFrame: From postoperative day 1 to day 7
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Health Sciences University
Study officials:
References: