Clinical trial NCT06770166: The Effect of Chamomile on Healing After Tooth Extraction
Official title: The Effect of Chamomile on Healing After Tooth Extraction: a Retrospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tooth Extraction Status Nos
Keywords: chamomile
chlorhexidine
tooth extraction
Lead sponsor: Istanbul Medipol University Hospital
Sponsor class: OTHER
First posted: 2025-01-13
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: A prospective randomized controlled clinical trial
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: Inclusion Criteria:

1. American Society of Anesthesiologists (ASA) physical status I patients,
2. did not have the medical history of being allergic to local anesthesia
3. did not have the medical history of being allergic to CHX,
4. did not have acute infection at the tooth area
5. absence of any pathology at the area.

Exclusion Criteria:

1. Participants with medically compromised condition,
2. pregnant females
3. smokers

Primary outcomes:
measure: Patients pain value
timeFrame: The patient marked the pain value every day for one week.
measure: maximum mouth opening
timeFrame: maximum mouth opening was measured preoperatively, postoperative 3rd and 7th days.
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Medipol University Dental School
state: Unkapani
Study officials:
affiliation: İstanbul Medipol university
name: reyhan saglam, PhD
role: PRINCIPAL_INVESTIGATOR
References: