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NCT Number: NCT07180498

Evaluation of the Effect of Tea Tree and Chlorhexidine Mouthwashes on Healing After Third Molar Extraction

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Harran University, Faculty of Dentistry

Sanliurfa, Turkey (Türkiye)

Location status: Recruiting

Location contact

mine alkaya karagoz

CONTACT

[email protected]

905365417606

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Chlorhexidine Gluconate 0.12% Mouthwash

Drug

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 mouthwash

Drug

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 outcomes

  1. 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.

  2. 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

  3. 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

Secondary outcomes

  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

    The level of periodontal healing of teeth in the adjacent area during the 7 days following impacted tooth extraction surgery

Study contacts

Contact information is provided by the study sponsor or research team.

Mine alkaya karagoz

CONTACT

[email protected]

905365417606

fatih yenigun

CONTACT

[email protected]

905369297833

Sponsors and collaborators

Lead sponsor

Harran University

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Sep 18, 2025
Registry last updated
Sep 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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