The Effect of Chamomile on Healing After Tooth Extraction

NCT ID: NCT06770166

Last Updated: 2025-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-01

Study Completion Date

2024-10-26

Brief Summary

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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

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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.

Conditions

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Tooth Extraction Status Nos

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

A prospective randomized controlled clinical trial
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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physiological serum mouthwash group (control group)

After extraction, 40 patients were given saline mouthwash to use for 7 days.

Group Type ACTIVE_COMPARATOR

Physiological serum mouthwash

Intervention Type OTHER

Physiological serum contains sodium chloride : 0.009 g/ml, sodium 154 (mEq/I), chloride 154 (mEq/I)\].

chlorhexidine mouthwash group

After extraction, 40 patients were given chlorhexidine mouthwash to use for 7 days.

Group Type ACTIVE_COMPARATOR

Chlorhexidine mouthwash

Intervention Type OTHER

Chlorhexidine mouthwash contains 0.12% chlorhexidine digluconate and 0.15% benzydamine hydrochloride.

chamomile mouthwash group

After extraction, 40 patients were given chamomile mouthwash to use for 7 days.

Group Type ACTIVE_COMPARATOR

Chamomile mouthwash

Intervention Type OTHER

Chamomile mouthwash contains 10% chamomile in physiological serum.

Interventions

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Physiological serum mouthwash

Physiological serum contains sodium chloride : 0.009 g/ml, sodium 154 (mEq/I), chloride 154 (mEq/I)\].

Intervention Type OTHER

Chlorhexidine mouthwash

Chlorhexidine mouthwash contains 0.12% chlorhexidine digluconate and 0.15% benzydamine hydrochloride.

Intervention Type OTHER

Chamomile mouthwash

Chamomile mouthwash contains 10% chamomile in physiological serum.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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reyhansaglam

OTHER

Sponsor Role lead

Responsible Party

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reyhansaglam

PhD

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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reyhan saglam, PhD

Role: PRINCIPAL_INVESTIGATOR

İstanbul Medipol university

Locations

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Istanbul Medipol University Dental School

Istanbul, Unkapani, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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10840098-604.01.01-21824

Identifier Type: -

Identifier Source: org_study_id

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