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

NCT07044219 | Not Yet Recruiting

• 1 other identifier: 7613-PTE 2019.
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Dry Socket; Postoperative Infections

Keywords

alveolitis; dry socket; dehiscence

Outcome Measures

Primary Outcomes (1)

• Wound healing

  Scoring wound healing according to Inflammatory Proliferative Remodelling (IPR) Wound Healing Scale: 0-16: the smaller number indicates the poorer outcome

  From enrollment to the end of treatment at 2 weeks

Secondary Outcomes (4)

• 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

• 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

Other Outcomes (1)

• Probing pocket depth

  From enrollment to the end of treatment at 2 weeks

Study Arms (2)

Curasept DNA ADS periodontal gel

EXPERIMENTAL

Procedure: Third molar surgery

Placebo gel wound dressing

PLACEBO COMPARATOR

Procedure: Third molar surgery

Interventions

Third molar surgery 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.

Curasept DNA ADS periodontal gel; Placebo gel wound dressing

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Pecs: lead

Study Sites (1)

Dept. of Oral and Maxillofacial Surgery, UP

Pécs, 7623, Hungary

Location

MeSH Terms

Conditions

Dry Socket

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Study Officials

• József Szalma, Prof, PhD, DSc

  UPMS Dept. Dentistry, Oral and Maxillofacial Surgery

  STUDY DIRECTOR

Central Study Contacts

József Szalma, Prof, PhD, DSc

CONTACT

+3672502426; szalma.jozsef@pte.hu

Balázs Soós, PhD

CONTACT

sosbala@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Participating investigator

Study Record Dates

• First Submitted: June 19, 2025
• First Posted: June 29, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: June 29, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

HU (1)