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

NCT ID: NCT07044219

Last Updated: 2025-06-29

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-01
• Study Completion Date: 2026-08-01

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.

Conditions

Dry Socket; Postoperative Infections

Keywords

alveolitis; dry socket; dehiscence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Curasept DNA ADS periodontal gel

Group Type: EXPERIMENTAL

Third molar surgery

Intervention Type: PROCEDURE

During the operation, after local anaesthetics (LIDOCAIN-ADRENALIN 20 mg/0,01 mg/ml) the same mucoperiosteal (sulcular flap without vertical incision) is raised. Bone removal happens with physio-dispenser driven surgical handpiece (60ml/min irrigation; 8.000-16.000 rpm) and tungsten carbide round drills. Tooth section is made where indicated. After tooth removal wound is rinsed with 10-20ml physiologic salt, the wound is closed with 4.0 monofil non-resorbable suture material and then gel test or placebo is injected with syringe and applicator tip into the wound and on the surface of the wound. Patient bites a gauze for 20 minutes.

Placebo gel wound dressing

Group Type: PLACEBO_COMPARATOR

Third molar surgery

Intervention Type: PROCEDURE

During the operation, after local anaesthetics (LIDOCAIN-ADRENALIN 20 mg/0,01 mg/ml) the same mucoperiosteal (sulcular flap without vertical incision) is raised. Bone removal happens with physio-dispenser driven surgical handpiece (60ml/min irrigation; 8.000-16.000 rpm) and tungsten carbide round drills. Tooth section is made where indicated. After tooth removal wound is rinsed with 10-20ml physiologic salt, the wound is closed with 4.0 monofil non-resorbable suture material and then gel test or placebo is injected with syringe and applicator tip into the wound and on the surface of the wound. Patient bites a gauze for 20 minutes.

Interventions

Third molar surgery

During the operation, after local anaesthetics (LIDOCAIN-ADRENALIN 20 mg/0,01 mg/ml) the same mucoperiosteal (sulcular flap without vertical incision) is raised. Bone removal happens with physio-dispenser driven surgical handpiece (60ml/min irrigation; 8.000-16.000 rpm) and tungsten carbide round drills. Tooth section is made where indicated. After tooth removal wound is rinsed with 10-20ml physiologic salt, the wound is closed with 4.0 monofil non-resorbable suture material and then gel test or placebo is injected with syringe and applicator tip into the wound and on the surface of the wound. Patient bites a gauze for 20 minutes.

Intervention Type: PROCEDURE

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Pecs

OTHER

Sponsor Role: lead

Responsible Party

Balazs Soos

Participating investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

József Szalma, Prof, PhD, DSc

Role: STUDY_DIRECTOR

UPMS Dept. Dentistry, Oral and Maxillofacial Surgery

Locations

Dept. of Oral and Maxillofacial Surgery, UP

Pécs, , Hungary

Countries

Hungary

Central Contacts

József Szalma, Prof, PhD, DSc

Role: CONTACT

Phone: +3672502426

Email: szalma.jozsef@pte.hu

Balázs Soós, PhD

Role: CONTACT

Email: sosbala@gmail.com

Facility Contacts

József Szalma, Prof, PhD, DSc

Role: primary

Other Identifiers

7613-PTE 2019.

Identifier Type: -

Identifier Source: org_study_id