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

NCT ID: NCT06920485

Last Updated: 2025-04-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-01

Study Completion Date

2027-04-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Oral Health

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Hypochlorous acid

Wound healing and microbiological analysis will be performed by administering hypochlorous acid to this group.

All surgical procedures will be performed under local anesthesia (80 mg articaine hydrochloride and 0.02 mg epinephrine, Maxicaine Fort ampoule, Vem İlaç, İstanbul, Turkey) and sterile conditions following the application of inferior alveolar block anesthesia + buccal mucosa anesthesia. Osteotomy (bone removal) and, if necessary, root dissection will be performed using a surgical handpiece with sterile saline solution and irrigation. Following tooth extraction, the socket will be checked and any sharp bone protrusions will be removed. The area will be closed primarily using non-resorbable silk suture material (surgical silk suture, 3/0, Doğsan, Turkey).

Group Type EXPERIMENTAL

Third molar surgery

Intervention Type 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

Intervention Type 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

Intervention Type DIAGNOSTIC_TEST

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

Total bacterial load

Intervention Type OTHER

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

Chlorhexidine gluconate

Wound healing and microbiological analysis will be performed by administering chlorhexidine gluconate to this group.

All surgical procedures will be performed under local anesthesia (80 mg articaine hydrochloride and 0.02 mg epinephrine, Maxicaine Fort ampoule, Vem İlaç, İstanbul, Turkey) and sterile conditions following the application of inferior alveolar block anesthesia + buccal mucosa anesthesia. Osteotomy (bone removal) and, if necessary, root dissection will be performed using a surgical handpiece with sterile saline solution and irrigation. Following tooth extraction, the socket will be checked and any sharp bone protrusions will be removed. The area will be closed primarily using non-resorbable silk suture material (surgical silk suture, 3/0, Doğsan, Turkey).

Group Type EXPERIMENTAL

Third molar surgery

Intervention Type 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

Intervention Type 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

Intervention Type DIAGNOSTIC_TEST

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

Total bacterial load

Intervention Type OTHER

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

Physiological serum

Wound healing and microbiological analysis will be performed by administering physiological serum to this group.

All surgical procedures will be performed under local anesthesia (80 mg articaine hydrochloride and 0.02 mg epinephrine, Maxicaine Fort ampoule, Vem İlaç, İstanbul, Turkey) and sterile conditions following the application of inferior alveolar block anesthesia + buccal mucosa anesthesia. Osteotomy (bone removal) and, if necessary, root dissection will be performed using a surgical handpiece with sterile saline solution and irrigation. Following tooth extraction, the socket will be checked and any sharp bone protrusions will be removed. The area will be closed primarily using non-resorbable silk suture material (surgical silk suture, 3/0, Doğsan, Turkey).

Group Type EXPERIMENTAL

Third molar surgery

Intervention Type 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

Intervention Type 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

Intervention Type DIAGNOSTIC_TEST

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

Total bacterial load

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Third molar surgery

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

Intervention Type PROCEDURE

Pain Medicine

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.

Intervention Type DIAGNOSTIC_TEST

Wound healing

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

Intervention Type DIAGNOSTIC_TEST

Total bacterial load

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Saglik Bilimleri Universitesi

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Özgün Yıldırım

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Health Sciences University

Ankara, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

06.02.2025-2025/3-25/1

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.