Impacted Mandibular Third MolarNCT07466992
Comparison of Chlorhexidine and Hypochlorous Acid Mouthwash After Impacted Third Molar Surgery
A study testing Hypochlorous Acid and Chlorhexidine Gluconate Mouthwash in people with Impacted Mandibular Third Molar, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Impacted Mandibular Third Molar
- What is being tested?
- Hypochlorous Acid and Chlorhexidine Gluconate Mouthwash
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2021to 1 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Van Yüzüncü Yıl Üniversitesi Diş Hekimliği Fakültesi
Van, 65580
About this study
Official title: 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.
- Conditions
- Impacted Mandibular Third Molar
- Being tested
- Hypochlorous Acid, Chlorhexidine Gluconate Mouthwash
- Keywords
- impacted third molar, hypochlorous acid, chlorhexidine gluconate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypochlorous AcidDrug
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.
Chlorhexidine Gluconate MouthwashDrug
Patients used chlorhexidine gluconate mouthwash starting 24 hours after surgery, three times daily.
| Study group | Role | What they receive |
|---|---|---|
| chlorhexidine gluconate | Active comparator | Patients used chlorhexidine gluconate mouthwash starting 24 hours after surgery, three times daily. Receives: Drug: Hypochlorous Acid; Drug: Chlorhexidine Gluconate Mouthwash |
| Hypochlorous Acid Mouthwash | Active comparator | Patients used hypochlorous acid mouthwash starting 24 hours after surgery, three times daily. Receives: Drug: Hypochlorous Acid; Drug: Chlorhexidine Gluconate Mouthwash |
What is being measured
The primary outcome is the main question the study is designed to answer.
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'.
Measured: 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.
Measured: 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.
Measured: preop, 2th and 7th days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start1 Dec 2021
- Primary completion1 Jul 2022
- Study completion1 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Impacted Mandibular Third MolarStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuzuncu Yil University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Serap Keskin Tunc, Yuzuncu Yil University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07466992
- Sponsor's protocol ID
- YYU-20/20.09.2021
- Status last verified
- Mar 2026
- First submitted
- 8 Mar 2026
- Last updated
- 12 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Effects of Hypochlorous Acid Versus Chlorhexidine Mouthwash Following Impacted Third Molar Extraction: A Randomized Split-Mouth Study
- ClinicalTrials.gov ID
- NCT07466992
- Acronym / sponsor ID
- YYU-20/20.09.2021
- Conditions
- Impacted Mandibular Third Molar
- Keywords
- impacted third molar, hypochlorous acid, chlorhexidine gluconate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Yuzuncu Yil UniversityUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 1 Aug 2022 (actual)
- First posted
- 12 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| chlorhexidine gluconate | Active comparator | Drug: Hypochlorous Acid, Drug: Chlorhexidine Gluconate MouthwashPatients used chlorhexidine gluconate mouthwash starting 24 hours after surgery, three times daily. |
| Hypochlorous Acid Mouthwash | Active comparator | Drug: Hypochlorous Acid, Drug: Chlorhexidine Gluconate MouthwashPatients used hypochlorous acid mouthwash starting 24 hours after surgery, three times daily. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypochlorous AcidHypochlorous 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. | Drug | Hypochlorous Acid Mouthwash, chlorhexidine gluconate |
| Chlorhexidine Gluconate MouthwashPatients used chlorhexidine gluconate mouthwash starting 24 hours after surgery, three times daily. | Drug | Hypochlorous Acid Mouthwash, chlorhexidine gluconate |
Primary outcome
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'.
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.
Edema
Time frame: preop, 2th and 7th days
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Antibacterial Effect and Soft Tissue Healing of Chlorhexidine-Coated Polyglactin 910 Sutures After Impacted Lower Third Molar Surgery
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypochlorous Acid and Chlorhexidine Gluconate Mouthwash in people with Impacted Mandibular Third Molar, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (VAS) (time frame: 3, 6, 12 and 24 hours and the 2nd, 3rd, 4th, 5th, 6th and 7th days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2026.