NCT06770166

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

March 1, 2019

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 26, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 26, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 6, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 13, 2025

Completed
Last Updated

January 13, 2025

Status Verified

January 1, 2025

Enrollment Period

5.7 years

First QC Date

January 6, 2025

Last Update Submit

January 9, 2025

Conditions

Keywords

chamomilechlorhexidinetooth extraction

Outcome Measures

Primary Outcomes (2)

  • Patients pain value

    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

    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.

Study Arms (3)

physiological serum mouthwash group (control group)

ACTIVE COMPARATOR

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

Other: Physiological serum mouthwash

chlorhexidine mouthwash group

ACTIVE COMPARATOR

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

Other: Chlorhexidine mouthwash

chamomile mouthwash group

ACTIVE COMPARATOR

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

Other: Chamomile mouthwash

Interventions

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

physiological serum mouthwash group (control group)

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

chlorhexidine mouthwash group

Chamomile mouthwash contains 10% chamomile in physiological serum.

chamomile mouthwash group

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Participants with medically compromised condition,
  • pregnant females
  • smokers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Medipol University Dental School

Istanbul, Unkapani, 34083, Turkey (Türkiye)

Location

Study Officials

  • reyhan saglam, PhD

    İstanbul Medipol university

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Model Details: A prospective randomized controlled clinical trial
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

January 6, 2025

First Posted

January 13, 2025

Study Start

March 1, 2019

Primary Completion

October 26, 2024

Study Completion

October 26, 2024

Last Updated

January 13, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations