The Effect of Chlorhexidine + Hyaluronic Acid on Postoperative Wound Healing After Lower Third Molar Removal
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Third molar surgery.
- Who it may be relevant to
- Registry conditions: Dry Socket, Postoperative Infections. Basic parameters: 18 years — 99 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Hungary
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official 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
Overview
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.
Interventions
- Procedure 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
Primary outcome measures
- Wound healing [Time frame: From enrollment to the end of treatment at 2 weeks]
Secondary outcome measures (4)
- Mouth opening [Time frame: From enrollment to the end of treatment at 2 weeks]
- Subjective pain level [Time frame: From enrollment to the end of treatment at 2 weeks]
- Face swelling [Time frame: From enrollment to the end of treatment at 2 weeks]
- Taken analgesics (questionaire) [Time frame: From enrollment to the end of treatment at 2 weeks]
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Hungary · 1 center
- Dept. of Oral and Maxillofacial Surgery, UP — Pécs
Identifiers
NCT: NCT07044219 · 7613-PTE 2019.