The Effect of Chlorhexidine + Hyaluronic Acid on Postoperative Wound Healing After Lower Third Molar Removal

Not Applicable

Not yet recruiting

• Conditions: Dry Socket; Postoperative Infections

• Registration Number: NCT07044219
• Lead Sponsor: University of Pecs

Brief Summary

Our aim is to evaluate chlorhexidine-hyaluronic acid containing gel on postoperative wound healing regarding impacted lower third molar surgery.

Detailed Description

This is a triple-blind, placebo-controlled randomized clinical trial. Sixty patients will be randomly assigned to two treatment groups: Arm 1 receives Curasept DNA ADS periodontal gel during impacted third molar removal, while Arm 2 receives a placebo gel. Patient allocation uses an electronic randomization system with a 1:1 ratio. Baseline characteristics are recorded at the first clinical visit. The surgical procedure includes local anesthesia, mucoperiosteal flap elevation, bone removal with a surgical handpiece, and wound closure with non-resorbable sutures. Test gel or placebo is applied post-tooth removal, and patients are monitored postoperatively for pain, swelling, and wound healing, including follow-ups on the third, seventh and fourteenth days. Data analysis will use descriptive and statistical methods to evaluate efficacy.

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-19
• Study First Submitted QC: 2025-06-27
• Last Update Submitted: 2025-06-27
• Study First Posted: 2025-06-29
• Last Update Posted: 2025-06-29
• Study Start: 2025-07-01
• Primary Completion: 2026-06-30
• Study Completion: 2026-08-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• patients having lower impacted third molar
• impaction pattern Pell-Gregory II/A, III/A, I/B, II/B, III/B that means partially impacted, partially erupted teeth, where primary wound closure is usually not possible;

Exclusion Criteria

• systemic disease (diabetes, steroids, antiresorptive therapy);
• allergy on gel's compounds;
• pregnancy;
• active or subacute local infection at third molar tooth (pericoronitis);
• poor oral hygiene (based on the presence of active caries and/or plaque index of 2-3)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Wound healing	From enrollment to the end of treatment at 2 weeks	Scoring wound healing according to Inflammatory Proliferative Remodelling (IPR) Wound Healing Scale: 0-16: the smaller number indicates the poorer outcome

Secondary Outcome Measures

Name	Time	Method
Mouth opening	From enrollment to the end of treatment at 2 weeks
Subjective pain level	From enrollment to the end of treatment at 2 weeks	Visual Analogue Scale (VAS) 0-10: the higher number indicates the more intense pain.
Face swelling	From enrollment to the end of treatment at 2 weeks
Taken analgesics (questionaire)	From enrollment to the end of treatment at 2 weeks	Reported amount of taken analgesics: 400 mg ibuprofen in each 6 hours in the first 48 hours, and after that as needed, but maximum 400 mg ibuprofen/6 hours +/- 500 mg paracetamol/6 hours.

Trial Locations

Locations (1)

Dept. of Oral and Maxillofacial Surgery, UP; 🇭🇺 Pécs, Hungary