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NCT Number: NCT07044219

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

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

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dept. of Oral and Maxillofacial Surgery, UP

Pécs, 7623, Hungary

Location contact

József Szalma, Prof, PhD, DSc

CONTACT

[email protected]

+3672502426

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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)

Treatment and study plan

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.

Primary outcomes

  1. Wound healing

    Time frame: 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 outcomes

  1. Mouth opening

    Time frame: From enrollment to the end of treatment at 2 weeks

  2. Subjective pain level

    Time frame: From enrollment to the end of treatment at 2 weeks

    Visual Analogue Scale (VAS) 0-10: the higher number indicates the more intense pain.

  3. Face swelling

    Time frame: From enrollment to the end of treatment at 2 weeks

  4. Taken analgesics (questionaire)

    Time frame: 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.

Other outcomes

  1. Probing pocket depth

    Time frame: From enrollment to the end of treatment at 2 weeks

    second molar

Study contacts

Contact information is provided by the study sponsor or research team.

Balázs Soós, PhD

CONTACT

[email protected]

József Szalma, Prof, PhD, DSc

CONTACT

[email protected]

+3672502426

Sponsors and collaborators

Lead sponsor

University of Pecs

Other

Registry information

Official study title

The Effect of Chlorhexidine (0.5%) With Combination of Hyaluronic Acid on Postoperative Wound Healing After Lower Third Molar Removal: a Placebo Controlled Triple Blind Randomized Clinical Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 29, 2025
Registry last updated
Jun 29, 2025

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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