- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06770166
The Effect of Chamomile on Healing After Tooth Extraction
January 9, 2025 updated by: reyhansaglam
The Effect of Chamomile on Healing After Tooth Extraction: a Retrospective Randomized Controlled Trial
After impacted wisdom tooth extraction, patients frequently complain of pain, edema, and limited mouth opening.
After the procedure, patients are routinely recommended to use chlorhexidine and physiological serum-based mouthwashes.
The antibacterial and anti-inflammatory effects of warm chamomile tea have been reported in the literature.
In addition, the neuroprotective, antiallergic, antioxidant, antiseptic and spasmolytic properties of chamomile have been reported.
The aim was to compare the effects of these gargles in terms of pain, mouth opening, burning sensation in the mouth, edema, and discoloration of the tongue and teeth.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The study was planned to be applied to 120 patients, 40 in each group.
In the ASA 1 group, the mouth opening of the patients was recorded before the tooth extraction procedure.
Impacted teeth were extracted using Ultracain D-S Forte (Articaine HCl: 40mg/ml, Epinephrine HCl: 0.012 mg/ml) as a local anesthetic.
Dental units were prepared under sterile conditions.
The patients were covered with a sterile drape.
The lower wisdom tooth was extracted with open (surgical) extraction.
The mucoperisoteal flap was lifted with a number 15 surgical scalpel, and the tooth was extracted using round and fissure-tipped steel burs with a handpiece.
After tooth extraction, if there was granulation tissue in the extraction socket, it was curetted and irrigated with physiological serum [sodium chloride: 0.009 g/ml, sodium 154 (mEq/I), chloride 154 (mEq/I)].
After bleeding control, patients were given written and verbal postoperative advice.
Antibiotics and analgesics were prescribed to patients, chlorhexidine gargle was recommended to 30 patients, saline gargle to 30 patients, and chamomile tea gargle to 30 patients.
Patients were given VAS pain scores, numbered 0-10, to record for 7 days after extraction.
Patients were called back to the clinic on the 2nd and 7th days after tooth extraction to assess pain, burning sensation and color change in the tongue, mouth opening, and edema.
Sutures were removed on the 7th postoperative day.
Study Type
Interventional
Enrollment (Actual)
120
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Unkapani
-
Istanbul, Unkapani, Turkey, 34083
- Istanbul Medipol University Dental School
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- American Society of Anesthesiologists (ASA) physical status I patients,
- did not have the medical history of being allergic to local anesthesia
- did not have the medical history of being allergic to CHX,
- did not have acute infection at the tooth area
- absence of any pathology at the area.
Exclusion Criteria:
- Participants with medically compromised condition,
- pregnant females
- smokers
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: physiological serum mouthwash group (control group)
After extraction, 40 patients were given saline mouthwash to use for 7 days.
|
Physiological serum contains sodium chloride : 0.009 g/ml, sodium 154 (mEq/I), chloride 154 (mEq/I)].
|
|
Active Comparator: chlorhexidine mouthwash group
After extraction, 40 patients were given chlorhexidine mouthwash to use for 7 days.
|
Chlorhexidine mouthwash contains 0.12% chlorhexidine digluconate and 0.15% benzydamine hydrochloride.
|
|
Active Comparator: chamomile mouthwash group
After extraction, 40 patients were given chamomile mouthwash to use for 7 days.
|
Chamomile mouthwash contains 10% chamomile in physiological serum.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patients pain value
Time Frame: The patient marked the pain value every day for one week.
|
visual analog scale (VAS) is used for pain assessment.
The patient marked the pain value on the 0-10 visual analog scale.
|
The patient marked the pain value every day for one week.
|
|
maximum mouth opening
Time Frame: maximum mouth opening was measured preoperatively, postoperative 3rd and 7th days.
|
maximum mouth openin were measured with the reference of 11 and 41 teeth.
are used for interincisal distances
|
maximum mouth opening was measured preoperatively, postoperative 3rd and 7th days.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: reyhan saglam, PhD, Istanbul Medipol University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2019
Primary Completion (Actual)
October 26, 2024
Study Completion (Actual)
October 26, 2024
Study Registration Dates
First Submitted
January 6, 2025
First Submitted That Met QC Criteria
January 9, 2025
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
January 9, 2025
Last Verified
January 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10840098-604.01.01-21824
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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