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.

Marmara University

Status: Completed

Conditions: Impacted Mandibular Third Molar

Treatments: Drug: Kloroben topical spray; Drug: Klorhex Plus topical spray

Study type: Interventional

Funder types: Other

Identifiers

NCT07416136

2015-KAEK-74-23-07

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

---

40 participants in 2 patient groups

Kloroben Topical Spray Group

Experimental group

Description:

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.

Treatment:

Drug: Klorhex Plus topical spray

Klorhex Plus Topical Spray Group

Active Comparator group

Description:

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.

Treatment:

Drug: Kloroben topical spray