The Aim of This Study is to Compare the Effects of Two Different Topical Agents (KLOROBEN® and KLORHEX PLUS®) Used in the Surgical Extraction of Mandibular Bilateral Mesioangular Impacted Third Molars on Postoperative Pain, Edema, and Trismus.

March 21, 2026 updated by: Edip Eren Kadıkıran, Marmara University

Investigation of the Effects of Chlorhexidine Gluconate + Benzydamine Hydrochloride and Chlorhexidine Gluconate + Flurbiprofen on Pain, Edema, and Trismus Following Mandibular Impacted Third Molar Extraction

This study aims to compare the effects of two commonly used topical mouth sprays on pain, swelling, and limitation of mouth opening after surgical removal of impacted lower wisdom teeth.

A total of 40 adult patients who require the removal of both lower impacted wisdom teeth will participate in this study. Each patient will undergo two separate surgical procedures, with a healing period between them. After each surgery, one of the two topical agents will be applied to the surgical area. The order of the treatments will be randomly assigned.

The study is designed so that neither the patients nor the clinician evaluating the outcomes will know which topical agent is used at each session.

Pain levels, facial swelling, and mouth opening will be measured at specific time points after surgery. The results will help determine whether one topical treatment is more effective than the other in reducing postoperative discomfort and improving recovery.

The information obtained from this study may contribute to improving postoperative care following wisdom tooth surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

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

  • Turkey (Türkiye)
    • Maltepe
      • Istanbul, Maltepe, Turkey (Türkiye), 34840
        • Marmara Unıversity Faculty of Dentistry

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

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Adults aged between 18 and 50 years
  • Indication for bilateral impacted mandibular third molar extraction
  • ASA physical status I or II
  • No antibiotic use within the previous two weeks
  • No analgesic use within the previous 12 hours
  • Ability to provide written informed consent

Exclusion Criteria:

  • ASA physical status III to V
  • Pregnancy or breastfeeding
  • Known allergy to chlorhexidine, benzydamine, or flurbiprofen
  • Smoking more than one pack per day
  • History of substance abuse
  • Presence of systemic diseases that may affect wound healing

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Kloroben Topical Spray Group
Following surgical extraction of the impacted mandibular third molar, Kloroben topical spray containing chlorhexidine gluconate and benzydamine hydrochloride is applied to the surgical site. Patients use the spray postoperatively according to the study protocol, and postoperative pain, swelling, and trismus are evaluated.
Drug: Klorhex Plus topical spray
Klorhex Plus topical spray containing chlorhexidine gluconate and flurbiprofen is applied to the surgical site immediately after impacted mandibular third molar extraction and used postoperatively according to the study protocol to reduce pain, swelling, and trismus.
Active Comparator: Klorhex Plus Topical Spray Group
Following surgical extraction of the impacted mandibular third molar, Klorhex Plus topical spray containing chlorhexidine gluconate and flurbiprofen is applied to the surgical site. Patients use the spray postoperatively according to the study protocol, and postoperative pain, swelling, and trismus are evaluated.
Drug: Kloroben topical spray
Kloroben topical spray containing chlorhexidine gluconate and benzydamine hydrochloride is applied to the surgical site immediately after impacted mandibular third molar extraction and used postoperatively according to the study protocol to reduce pain, swelling, and trismus.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative pain intensity assessed by Visual Analog Scale (VAS)
Time Frame: From 30 minutes to 168 hours after surgery
Postoperative pain intensity assessed by the Visual Analog Scale (VAS, 0-10 cm), where 0 indicates no pain and 10 indicates worst imaginable pain; higher scores indicate greater pain intensity.
From 30 minutes to 168 hours after surgery
Postoperative facial swelling measurements
Time Frame: Preoperatively, postoperative day 2 and postoperative day 7
Postoperative facial swelling measured by linear facial distances (in centimeters) including tragus to pogonion, tragus to labial commissure, and mandibular angle to lateral canthus; higher values indicate greater swelling.
Preoperatively, postoperative day 2 and postoperative day 7
Maximum mouth opening (trismus assessment)
Time Frame: Preoperatively, postoperative day 2 and postoperative day 7
Trismus will be evaluated by measuring the maximum interincisal distance between the upper and lower central incisors using a ruler.
Preoperatively, postoperative day 2 and postoperative day 7

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative analgesic consumption
Time Frame: From the day of surgery to postoperative day 7
The number of analgesic tablets consumed by each patient will be recorded daily following surgery.
From the day of surgery to postoperative day 7

Collaborators and Investigators

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

Sponsor

Marmara University

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)

April 20, 2025

Primary Completion (Actual)

August 15, 2025

Study Completion (Actual)

October 19, 2025

Study Registration Dates

First Submitted

February 8, 2026

First Submitted That Met QC Criteria

February 12, 2026

First Posted (Actual)

February 17, 2026

Study Record Updates

Last Update Posted (Actual)

March 25, 2026

Last Update Submitted That Met QC Criteria

March 21, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2015-KAEK-74-23-07

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared due to patient confidentiality, institutional policies, and local ethical regulations.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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