An interventional study of Chlorhexidine Gluconate 0.12% Mouthwash and Tea Tree Oil mouthwash in Postoperative Pain, Postoperative Complications and Trismus, sponsored by Harran University. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-18.
Sponsored by Harran University · Not applicable, Interventional, and Supportive care
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:
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.
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.
5,640 studies on the registry are indexed under Pain, Postoperative; 1,230 are open to participants now.
This study's planned enrollment of 54 is below the median of 75 across 4,821 interventional studies indexed under Pain, Postoperative.
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Exclusion Criteria:
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An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
They will be instructed to gargle with chlorhexidine after brushing their teeth three times daily for 7 days.
Drug: Chlorhexidine Gluconate 0.12% Mouthwash
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.
Drug: Tea Tree Oil mouthwash
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.
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.
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.
Time frame: preoperative, postoperative day 2, post operative day 7
amount of mouth opening
Restriction in mouth opening for 7 days after impacted tooth extraction surgery
Time frame: 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
Time frame: preoperative, postoperative day 2, post operative day 7
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
Time frame: preoperative, postoperative day 2, post operative day 7
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Studies of the drug tested here: Tea Tree Oil
Harran University