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Completed

NCT Number: NCT07416136

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.

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.

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Key information

Conditions

Impacted Mandibular Third Molar

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Marmara Unıversity Faculty of Dentistry

Istanbul, Maltepe, 34840, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Marmara University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 17, 2026
Registry last updated
Mar 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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