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.

NCT07416136 | Completed

• 1 other identifier: 2015-KAEK-74-23-07
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Impacted Mandibular Third Molar

Keywords

wisdom tooth surgery; postoperative morbidity; chlorhexidine; benzydamine; flurbiprofen; split-mouth study

Outcome Measures

Primary Outcomes (3)

• Postoperative pain intensity assessed by Visual Analog Scale (VAS)

  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

  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)

  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 Outcomes (1)

• Postoperative analgesic consumption

  From the day of surgery to postoperative day 7

Study Arms (2)

Kloroben Topical Spray Group

EXPERIMENTAL

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 Group

ACTIVE COMPARATOR

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

Interventions

Kloroben topical spray DRUG

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.

Klorhex Plus Topical Spray Group

Klorhex Plus topical spray DRUG

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.

Kloroben Topical Spray Group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara Unıversity Faculty of Dentistry

Istanbul, Maltepe, 34840, Turkey (Türkiye)

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Monitor Clinician
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Model Details: This is a randomized, double-blind, crossover (split-mouth) clinical trial. Each participant undergoes two separate surgical procedures for bilateral impacted mandibular third molar extraction. After each procedure, a different topical agent is applied in a randomized order, with a healing period between interventions. Outcomes are compared within the same participant to minimize inter-individual variability.

Study Record Dates

• First Submitted: February 8, 2026
• First Posted: February 17, 2026
• Study Start: April 20, 2025
• Primary Completion: August 15, 2025
• Study Completion: October 19, 2025
• Last Updated: March 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)