NCT06880952

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
145

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2021

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 24, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 19, 2022

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

March 10, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 18, 2025

Completed
Last Updated

March 18, 2025

Status Verified

March 1, 2025

Enrollment Period

7 months

First QC Date

March 10, 2025

Last Update Submit

March 17, 2025

Conditions

Keywords

third molarchlorhexidine

Outcome Measures

Primary Outcomes (1)

  • Postoperative pain after removal of third molar

    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 Outcomes (1)

  • Post-operative complications

    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.

Study Arms (2)

Post-operative rinsing with chlorhexidine

OTHER

In the rinsing group, the patients received a bottle of 0,2% chlorhexidine

Other: Chlorhexidine Digluconate Mouthwash without Alcohol

No post-operative rinsing

NO INTERVENTION

Those allocated to the control group received no post-operative rinsing

Interventions

In the rinsing group, the patients received a bottle of 0,2% chlorhexidine

Post-operative rinsing with chlorhexidine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Isala Hospital

Zwolle, Overijssel, 8025AB, Netherlands

Location

Related Publications (1)

  • Ghaeminia H, Hoppenreijs TJ, Xi T, Fennis JP, Maal TJ, Berge SJ, Meijer GJ. Postoperative socket irrigation with drinking tap water reduces the risk of inflammatory complications following surgical removal of third molars: a multicenter randomized trial. Clin Oral Investig. 2017 Jan;21(1):71-83. doi: 10.1007/s00784-016-1751-1. Epub 2016 Feb 27.

    PMID: 26922634BACKGROUND

MeSH Terms

Interventions

Ethanol

Intervention Hierarchy (Ancestors)

AlcoholsOrganic Chemicals

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Oral Surgeon and Principal Investigator

Study Record Dates

First Submitted

March 10, 2025

First Posted

March 18, 2025

Study Start

September 1, 2021

Primary Completion

March 24, 2022

Study Completion

August 19, 2022

Last Updated

March 18, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations