Postoperative PainNCT07180498
Evaluation of the Effect of Tea Tree and Chlorhexidine Mouthwashes on Healing After Third Molar Extraction
A study testing Chlorhexidine Gluconate 0.12% Mouthwash and Tea Tree Oil mouthwash in people with Postoperative Pain and Postoperative Complications, run by Harran University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this clinical study is to compare the effects of mouthwashes containing Chlorhexidine and tea tree oil on edema, pain, and trismus after the extraction of impacted third molars. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain, Postoperative Complications, Trismus
- What is being tested?
- Chlorhexidine Gluconate 0.12% Mouthwash and Tea Tree Oil mouthwash
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Apr 2025to 30 Dec 2025
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Individuals undergoing extraction of Class 2, Class B mandibular third molars impacted in the lower jaw (Pell \& Gregory).
- Individuals aged 18-65.
- Individuals must be in stable general health (e.g., free of serious cardiovascular or kidney disease).
- Individuals willing to use tea tree extract or other treatments.
Who cannot join
- Individuals with a known allergy or hypersensitivity to tea tree extract.
- Individuals with serious illnesses such as heart failure or kidney disease. Patients with bleeding disorders.
- Individuals during pregnancy and breastfeeding.
- Individuals taking medications that may interact with tea tree extract (e.g., blood thinners or antihypertensives)
- Individuals previously treated for edema.
- Individuals with chronic edema.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Harran University, Faculty of Dentistry
Sanliurfa
mine alkaya karagoz, 905365417606, mine.karagoz@alanya.edu.tr
About this study
Official title: The Evaluation of the Effects of Chlorhexidine and Tea Tree Oil Mouthwash on Postoperative Complications and Periodontal Healing After the Extraction of Impacted Third Molars
The purpose of this clinical study is to compare the effects of mouthwashes containing Chlorhexidine and tea tree oil on edema, pain, and trismus after the extraction of impacted third molars. Additionally, the effects on periodontal health will be examined by comparing the gum healing processes of patients using both mouthwashes.The main questions it aims to answer are:
- Tea tree oil, said to have anti-inflammatory and antibacterial effects, could be an alternative to chlorhexidine in reducing postoperative complications after impacted tooth extraction.
- Does tea tree oil, which has antimicrobial effects, have as positive an impact on periodontal health as chlorhexidine?Researchers will compare tea tree oil to chlorhexidine (routinely prescribed after the extraction of an impacted wisdom tooth) to see if tea tree oil works to decrease postoperative complications.
Read more
Participants will:
For 7 days after the operation, they will gargle with chlorhexidine mouthwash or mouthwash containing tea tree oil 3 times a day. They will come to the clinic for check-ups and measurements on the 2nd and 7th days after the operation. They will record their pain levels and the number of painkillers they take daily.
Read the detailed description
The G x Power 3.1.9.7 program was used to calculate the sample size for this study. It was calculated that a total of 54 patients, with at least 27 patients in each group, would be included at a significance level of α=0.05 under 95% power.
Class 2 and Class B impacted third molars were selected as the ideal study group. All surgeries will be performed under local anesthesia by the same experienced oral surgeon, following standard surgical protocols. Patients will be provided with postoperative care instructions. Patients will be monitored for 7 days after surgery to assess postoperative healing. The experimental groups will receive 100% tea tree oil and a dropper. They will be instructed to gargle with 3 drops of tea tree oil added to 100 mL of water (approximately half a glass of water) after brushing their teeth three times daily for 7 days. The standard recommended antibiotic will be amoxicillin-clavulanic acid (875-125 mg, 2 tablets x 1) and paracetamol (500 mg) as a pain reliever.
The Active Comparator group will follow the standard care protocol, brushing their teeth three times daily for 7 days, followed by the use of 0.12% chlorhexidine gluconate mouthwash. The standard recommended antibiotic will be amoxicillin-clavulanic acid (875-125 mg, 2 tablets per day), and paracetamol (500 mg) will be prescribed as a painkiller.
Before the operation, measurements will be taken and recorded from the angle-labial commissure, angle-external eye angle, angle-tragus, angle-pogonion, and angle-nasal crease. The amount of plaque will be examined from all surfaces of the second molar, and the presence or absence of plaque will be noted. The patient's maximum mouth opening will be measured using a ruler. These measurements are used to compare the presence of post-operative edema and trismus.
The patient will be given a 7-day Visual Analog Scale (VAS) chart for post-extraction pain management. They will be asked to rate their pain daily for 7 days, ranging from 0 (no pain) to 10 (worst imaginable pain), and to note the number of painkillers they have used. • After tooth extraction, the patient will be called for follow-up appointments on the 2nd and 7th days. At these appointments, the patient will have plaque, maximum mouth opening, and distances between anatomical landmarks for edema assessments measured and noted.
- Being tested
- Chlorhexidine Gluconate 0.12% Mouthwash, Tea Tree Oil mouthwash
- Keywords
- tea tree oil, third molar surgery, postoperative complications, chlorhexidine digluconate
- Medical subject headings
- Pain, Postoperative, Postoperative Complications, Trismus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chlorhexidine Gluconate 0.12% MouthwashDrug
Participants will be prescribed to gargle with chlorhexidine, which is the routine recommendation after brushing their teeth 3 times a day for 7 days after the impacted tooth extraction.
Tea Tree Oil mouthwashDrug
Participants will be prescribed to gargle with tea tree oil-containing water after brushing their teeth three times a day for 7 days following the extraction of an impacted tooth.
| Study group | Role | What they receive |
|---|---|---|
| chlorhexidine group | Active comparator | They will be instructed to gargle with chlorhexidine after brushing their teeth three times daily for 7 days. Receives: Drug: Chlorhexidine Gluconate 0.12% Mouthwash |
| tea tree oil group | Experimental | They will be instructed to gargle with 3 drops of tea tree oil added to 100 mL of water (approximately half a glass of water) after brushing their teeth three times daily for 7 days. Receives: Drug: Tea Tree Oil mouthwash |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain VAS measurement
The patient will be given a chart with a 7-day VAS scale for pain control after tooth extraction. They will be asked to record their pain daily on a scale of 0 (no pain) to 10 (the worst imaginable pain) for 7 days, and to note how many painkillers they used.
Measured: preoperative, postoperative day 2, post operative day 7
amount of mouth opening
Restriction in mouth opening for 7 days after impacted tooth extraction surgery
Measured: preoperative, postoperative day 2, post operative day 7
distance from the angulus to the labial commissure, external eye angle, tragus, pogonion, and nasal line
The amount of facial swelling during the 7 days following impacted tooth extraction surgery
Measured: preoperative, postoperative day 2, post operative day 7
Secondary outcomes (1)
Pocket depth measurement of the second molar tooth next to the extraction site and assessment of plaque presence
The level of periodontal healing of teeth in the adjacent area during the 7 days following impacted tooth extraction surgery
Measured: preoperative, postoperative day 2, post operative day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2025
- Study start15 Apr 2025
- Primary completion30 Oct 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Harran University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mine alkaya karagoz, Harran University
- Investigators
- Mine alkaya karagoz, Principal investigator, Harran University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07180498
- Sponsor's protocol ID
- HRU/25.07.49
- Status last verified
- Sep 2025
- First submitted
- 1 Sep 2025
- Last updated
- 18 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of the Effects of Chlorhexidine and Tea Tree Oil Mouthwash on Postoperative Complications and Periodontal Healing After the Extraction of Impacted Third Molars
- ClinicalTrials.gov ID
- NCT07180498
- Acronym / sponsor ID
- HRU/25.07.49
- Keywords
- tea tree oil, third molar surgery, postoperative complications, chlorhexidine digluconate
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Harran UniversityUniversity, hospital or other
- Study start
- 15 Apr 2025 (actual)
- Primary completion
- 30 Oct 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 18 Sep 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.
The purpose of this clinical study is to compare the effects of mouthwashes containing Chlorhexidine and tea tree oil on edema, pain, and trismus after the extraction of impacted third molars. Additionally, the effects on periodontal health will be examined by comparing the gum healing processes of patients using both mouthwashes.The main questions it aims to answer are:
- Tea tree oil, said to have anti-inflammatory and antibacterial effects, could be an alternative to chlorhexidine in reducing postoperative complications after impacted tooth extraction.
- Does tea tree oil, which has antimicrobial effects, have as positive an impact on periodontal health as chlorhexidine?Researchers will compare tea tree oil to chlorhexidine (routinely prescribed after the extraction of an impacted wisdom tooth) to see if tea tree oil works to decrease postoperative complications.
Participants will:
For 7 days after the operation, they will gargle with chlorhexidine mouthwash or mouthwash containing tea tree oil 3 times a day. They will come to the clinic for check-ups and measurements on the 2nd and 7th days after the operation. They will record their pain levels and the number of painkillers they take daily.
Detailed description
The G x Power 3.1.9.7 program was used to calculate the sample size for this study. It was calculated that a total of 54 patients, with at least 27 patients in each group, would be included at a significance level of α=0.05 under 95% power.
Class 2 and Class B impacted third molars were selected as the ideal study group. All surgeries will be performed under local anesthesia by the same experienced oral surgeon, following standard surgical protocols. Patients will be provided with postoperative care instructions. Patients will be monitored for 7 days after surgery to assess postoperative healing. The experimental groups will receive 100% tea tree oil and a dropper. They will be instructed to gargle with 3 drops of tea tree oil added to 100 mL of water (approximately half a glass of water) after brushing their teeth three times daily for 7 days. The standard recommended antibiotic will be amoxicillin-clavulanic acid (875-125 mg, 2 tablets x 1) and paracetamol (500 mg) as a pain reliever.
The Active Comparator group will follow the standard care protocol, brushing their teeth three times daily for 7 days, followed by the use of 0.12% chlorhexidine gluconate mouthwash. The standard recommended antibiotic will be amoxicillin-clavulanic acid (875-125 mg, 2 tablets per day), and paracetamol (500 mg) will be prescribed as a painkiller.
Before the operation, measurements will be taken and recorded from the angle-labial commissure, angle-external eye angle, angle-tragus, angle-pogonion, and angle-nasal crease. The amount of plaque will be examined from all surfaces of the second molar, and the presence or absence of plaque will be noted. The patient's maximum mouth opening will be measured using a ruler. These measurements are used to compare the presence of post-operative edema and trismus.
The patient will be given a 7-day Visual Analog Scale (VAS) chart for post-extraction pain management. They will be asked to rate their pain daily for 7 days, ranging from 0 (no pain) to 10 (worst imaginable pain), and to note the number of painkillers they have used. • After tooth extraction, the patient will be called for follow-up appointments on the 2nd and 7th days. At these appointments, the patient will have plaque, maximum mouth opening, and distances between anatomical landmarks for edema assessments measured and noted.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| chlorhexidine group | Active comparator | Drug: Chlorhexidine Gluconate 0.12% MouthwashThey will be instructed to gargle with chlorhexidine after brushing their teeth three times daily for 7 days. |
| tea tree oil group | Experimental | Drug: Tea Tree Oil mouthwashThey will be instructed to gargle with 3 drops of tea tree oil added to 100 mL of water (approximately half a glass of water) after brushing their teeth three times daily for 7 days. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Individuals undergoing extraction of Class 2, Class B mandibular third molars impacted in the lower jaw (Pell \& Gregory).
- Individuals aged 18-65.
- Individuals must be in stable general health (e.g., free of serious cardiovascular or kidney disease).
- Individuals willing to use tea tree extract or other treatments.
Key exclusion criteria (6 listed)
- Individuals with a known allergy or hypersensitivity to tea tree extract.
- Individuals with serious illnesses such as heart failure or kidney disease. Patients with bleeding disorders.
- Individuals during pregnancy and breastfeeding.
- Individuals taking medications that may interact with tea tree extract (e.g., blood thinners or antihypertensives)
- Individuals previously treated for edema.
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 |
|---|---|---|
| Chlorhexidine Gluconate 0.12% MouthwashParticipants will be prescribed to gargle with chlorhexidine, which is the routine recommendation after brushing their teeth 3 times a day for 7 days after the impacted tooth extraction. | Drug | chlorhexidine group |
| Tea Tree Oil mouthwashParticipants will be prescribed to gargle with tea tree oil-containing water after brushing their teeth three times a day for 7 days following the extraction of an impacted tooth. | Drug | tea tree oil group |
Primary outcome
pain VAS measurement
Time frame: preoperative, postoperative day 2, post operative day 7
The patient will be given a chart with a 7-day VAS scale for pain control after tooth extraction. They will be asked to record their pain daily on a scale of 0 (no pain) to 10 (the worst imaginable pain) for 7 days, and to note how many painkillers they used.
amount of mouth opening
Time frame: preoperative, postoperative day 2, post operative day 7
Restriction in mouth opening for 7 days after impacted tooth extraction surgery
distance from the angulus to the labial commissure, external eye angle, tragus, pogonion, and nasal line
Time frame: preoperative, postoperative day 2, post operative day 7
The amount of facial swelling during the 7 days following impacted tooth extraction surgery
1 secondary outcome
Pocket depth measurement of the second molar tooth next to the extraction site and assessment of plaque presence
Time frame: preoperative, postoperative day 2, post operative 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 18 Sep 2025.
Related trials for Postoperative Pain
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
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.
Mine alkaya karagoz principal investigator
Harran University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chlorhexidine Gluconate 0.12% Mouthwash and Tea Tree Oil mouthwash in people with Postoperative Pain and Postoperative Complications, run by Harran 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: looking for participants now, as of the sponsor's last update on 18 Sep 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?
Contact Mine alkaya karagoz (905365417606, minekaragoz@harran.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain VAS measurement (time frame: preoperative, postoperative day 2, post operative 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 18 Sep 2025; AzTrials last refreshed its copy on 8 Nov 2026.