NCT07180498

Brief 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. 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. 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. 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
54

participants targeted

Target at P25-P50 for not_applicable postoperative-pain

Timeline
Completed

Started Apr 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 15, 2025

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 1, 2025

Completed
17 days until next milestone

First Posted

Study publicly available on registry

September 18, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

September 18, 2025

Status Verified

September 1, 2025

Enrollment Period

7 months

First QC Date

September 1, 2025

Last Update Submit

September 15, 2025

Conditions

Keywords

tea tree oilthird molar surgerypostoperative complicationschlorhexidine digluconate

Outcome Measures

Primary Outcomes (3)

  • 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.

    preoperative, postoperative day 2, post operative day 7

  • amount of mouth opening

    Restriction in mouth opening for 7 days after impacted tooth extraction surgery

    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

    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

    preoperative, postoperative day 2, post operative day 7

Study Arms (2)

chlorhexidine group

ACTIVE COMPARATOR

They will be instructed to gargle with chlorhexidine after brushing their teeth three times daily for 7 days.

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.

Drug: Tea Tree Oil mouthwash

Interventions

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.

chlorhexidine group

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.

tea tree oil group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Harran University, Faculty of Dentistry

Sanliurfa, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pain, PostoperativePostoperative ComplicationsTrismus

Interventions

chlorhexidine gluconateMouthwashes

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsSpasmNeuromuscular ManifestationsNervous System Diseases

Intervention Hierarchy (Ancestors)

Biomedical and Dental MaterialsSpecialty Uses of ChemicalsChemical Actions and UsesCosmeticsManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Mine alkaya karagoz

    Harran University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mine alkaya karagoz

CONTACT

fatih yenigun

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

September 1, 2025

First Posted

September 18, 2025

Study Start

April 15, 2025

Primary Completion

October 30, 2025

Study Completion

December 30, 2025

Last Updated

September 18, 2025

Record last verified: 2025-09

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