- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07466992
Comparison of Chlorhexidine and Hypochlorous Acid Mouthwash After Impacted Third Molar Surgery
Postoperative Effects of Hypochlorous Acid Versus Chlorhexidine Mouthwash Following Impacted Third Molar Extraction: A Randomized Split-Mouth Study
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Van, Turkey (Türkiye), 65580
- Van Yüzüncü Yıl Üniversitesi Diş Hekimliği Fakültesi
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: chlorhexidine gluconate
Patients used chlorhexidine gluconate mouthwash starting 24 hours after surgery, three times daily.
|
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.
Patients used chlorhexidine gluconate mouthwash starting 24 hours after surgery, three times daily.
|
|
Active Comparator: Hypochlorous Acid Mouthwash
Patients used hypochlorous acid mouthwash starting 24 hours after surgery, three times daily.
|
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.
Patients used chlorhexidine gluconate mouthwash starting 24 hours after surgery, three times daily.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Trismus
Time Frame: preop, 2th and 7th days
|
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.
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preop, 2th and 7th days
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Edema
Time Frame: preop, 2th and 7th days
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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
|
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Visual Analog Scale (VAS)
Time Frame: 3, 6, 12 and 24 hours and the 2nd, 3rd, 4th, 5th, 6th and 7th days
|
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
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- YYU-20/20.09.2021
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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