Evaluation of the Effect of Tea Tree and Chlorhexidine Mouthwashes on Healing After Third Molar Extraction
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Chlorhexidine Gluconate 0.12% Mouthwash, Tea Tree Oil mouthwash.
- Who it may be relevant to
- Registry conditions: Postoperative Pain, Postoperative Complications, Trismus, Periodontal Health. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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: 1. 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. 2. 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.
Interventions
- Drug Chlorhexidine Gluconate 0.12% 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. - Drug Tea Tree Oil mouthwash
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.
Primary outcome measures
- pain VAS measurement [Time frame: preoperative, postoperative day 2, post operative day 7]
- amount of mouth opening [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 [Time frame: preoperative, postoperative day 2, post operative day 7]
Secondary outcome measures (1)
- 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]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Supportive care
Study locations
Turkey (Türkiye) · 1 center
- Harran University, Faculty of Dentistry — Sanliurfa
Identifiers
NCT: NCT07180498 · HRU/25.07.49