Oral HealthMouthwashNCT06920485
Effect of Hypochlorous Acid-containing Mouthwash on Healing After Impacted Wisdom Tooth Surgery
A study testing Third molar surgery, Pain Medicine and Wound healing in people with Oral Health, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Health
- What is being tested?
- Third molar surgery, Pain Medicine and Wound healing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2025to 1 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Clinical and Microbiological Evaluation of the Effects of Hypochlorous Acid Mouthwash Use in the Postoperative Period of Mandibular Third Molar Tooth Extractions
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.
- Conditions
- Oral Health
- Being tested
- Third molar surgery, Pain Medicine, Wound healing, Total bacterial load
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Third molar surgeryProcedure or surgery
Effects of different gargles/mouth rinses/antiseptic agents applied after impacted surgical tooth extraction on postoperative wound healing and total bacterial load
Pain MedicineDiagnostic 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 healingDiagnostic test
The degree of healing of the wound area will be checked using Landry scoring.
Total bacterial loadOther
Total bacterial load will be evaluated by microbiological analysis of sutures obtained from all groups.
| Study group | Role | What they receive |
|---|---|---|
| Hypochlorous acid | Experimental | 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). Receives: Procedure: Third molar surgery; Diagnostic Test: Pain Medicine; Diagnostic Test: Wound healing; Other: Total bacterial load |
| Chlorhexidine gluconate | Experimental | 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). Receives: Procedure: Third molar surgery; Diagnostic Test: Pain Medicine; Diagnostic Test: Wound healing; Other: Total bacterial load |
| Physiological serum | Experimental | 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). Receives: Procedure: Third molar surgery; Diagnostic Test: Pain Medicine; Diagnostic Test: Wound healing; Other: Total bacterial load |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain levels after mandibular third molar surgery
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)
Measured: From postoperative day 1 to day 7
Total bacterial load on suture materials evaluated by qPCR
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
Measured: Postoperative day 7
Wound healing status on 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)
Measured: Postoperative day 7
Secondary outcomes (1)
Number of analgesic tablets consumed postoperatively
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
Measured: From postoperative day 1 to day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2025
- Study start1 May 2025 (estimated)
- Primary completion1 Apr 2026 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral HealthStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Özgün Yıldırım, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06920485
- Sponsor's protocol ID
- 06.02.2025-2025/3-25/1
- Acronym
- Mouthwash
- Status last verified
- Apr 2025
- First submitted
- 19 Mar 2025
- Last updated
- 16 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Patient information will be kept confidential.
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Microbiological Evaluation of the Effects of Hypochlorous Acid Mouthwash Use in the Postoperative Period of Mandibular Third Molar Tooth Extractions
- ClinicalTrials.gov ID
- NCT06920485
- Acronym / sponsor ID
- Mouthwash / 06.02.2025-2025/3-25/1
- Conditions
- Oral Health
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 1 May 2025 (estimated)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 9 Apr 2025 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hypochlorous acid | Experimental | Procedure: Third molar surgery, Diagnostic Test: Pain Medicine, Diagnostic Test: Wound healing, Other: Total bacterial loadWound 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). |
| Chlorhexidine gluconate | Experimental | Procedure: Third molar surgery, Diagnostic Test: Pain Medicine, Diagnostic Test: Wound healing, Other: Total bacterial loadWound 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). |
| Physiological serum | Experimental | Procedure: Third molar surgery, Diagnostic Test: Pain Medicine, Diagnostic Test: Wound healing, Other: Total bacterial loadWound 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). |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
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 |
|---|---|---|
| Third molar surgeryEffects of different gargles/mouth rinses/antiseptic agents applied after impacted surgical tooth extraction on postoperative wound healing and total bacterial load | Procedure or surgery | Chlorhexidine gluconate, Hypochlorous acid, Physiological serum |
| Pain MedicineAfter 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. | Diagnostic test | Chlorhexidine gluconate, Hypochlorous acid, Physiological serum |
| Wound healingThe degree of healing of the wound area will be checked using Landry scoring. | Diagnostic test | Chlorhexidine gluconate, Hypochlorous acid, Physiological serum |
| Total bacterial loadTotal bacterial load will be evaluated by microbiological analysis of sutures obtained from all groups. | Other | Chlorhexidine gluconate, Hypochlorous acid, Physiological serum |
Primary outcome
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)
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
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)
1 secondary outcome
Number of analgesic tablets consumed postoperatively
Time frame: From postoperative day 1 to day 7
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2025.
- Individual participant dataSharing planned: No. Patient information will be kept confidential.
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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.
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 Third molar surgery, Pain Medicine and Wound healing in people with Oral Health, run by Saglik Bilimleri Universitesi 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 11 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: enrolling by invitation, as of the sponsor's last update on 16 Apr 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Change in pain levels after mandibular third molar surgery (time frame: From postoperative day 1 to day 7). 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 16 Apr 2025.