Effect of Post-operative Chlorhexidine on Postoperative Pain and Complications After Surgical Removal of Mandibular Third Molars (RITOR)

March 17, 2025 updated by: Jeroen van der Sleen, Isala

Effect of Post-operative Chlorhexidine on Postoperative Pain and Complications After Surgical Removal of Mandibular Third Molars: a Randomized Controlled Trial

This study aimed to assess the impact of postoperative chlorhexidine use on pain management following mandibular third molar removal

In this prospective, randomized controlled trial,130 patients who underwent mandibular third molar surgical removal were divided into two groups: one group used chlorhexidine for postoperative rinsing and the other did not rinse. Pain levels, measured using the Numeric Rating Scale (NRS), were recorded daily for the first seven days post-surgery. Paired-samples t-tests were utilized for data analysis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

145

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

  • Netherlands
    • Overijssel
      • Zwolle, Overijssel, Netherlands, 8025AB
        • Isala Hospital

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
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

• healthy adults (18+) referred by their dentist for third molar removal

Exclusion Criteria:

  • active pericoronitis or other infections
  • planned coronectomy
  • trismus
  • chronic pain
  • pregnancy
  • known allergies to local anesthesia

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Post-operative rinsing with chlorhexidine
In the rinsing group, the patients received a bottle of 0,2% chlorhexidine
Other: Chlorhexidine Digluconate Mouthwash without Alcohol
In the rinsing group, the patients received a bottle of 0,2% chlorhexidine
No Intervention: No post-operative rinsing
Those allocated to the control group received no post-operative rinsing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative pain after removal of third molar
Time Frame: 7 days after the inclusion pain was measured on a numerical rating scale
The primary endpoint is the difference in the postoperative pain measured on a numerical rating scale (NRS) evaluated at seven days
7 days after the inclusion pain was measured on a numerical rating scale

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-operative complications
Time Frame: 7 days after the treatment the patient was seen at the outpatient clinic for clinical assessment. At this moment the number of patients with alveolitis, foodimpaction and bleeding was scored.
As secondary outcome measures alveolitis, foodimpaction, bleeding or infection
7 days after the treatment the patient was seen at the outpatient clinic for clinical assessment. At this moment the number of patients with alveolitis, foodimpaction and bleeding was scored.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Isala

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

September 1, 2021

Primary Completion (Actual)

March 24, 2022

Study Completion (Actual)

August 19, 2022

Study Registration Dates

First Submitted

March 10, 2025

First Submitted That Met QC Criteria

March 17, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 17, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 71727.075.20

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

product manufactured in and exported from the U.S.

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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