The Effect of Chlorhexidine + Hyaluronic Acid on Postoperative Wound Healing After Lower Third Molar Removal
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-99
SponsorUniversity of Pecs
About this trial
Our aim is to evaluate chlorhexidine-hyaluronic acid containing gel on postoperative wound healing regarding impacted lower third molar surgery.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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;
Disqualifiers
systemic disease (diabetes, steroids, antiresorptive therapy);
allergy on gel's compounds;
pregnancy;
active or subacute local infection at third molar tooth (pericoronitis);
Trial design
Design model
Parallel
Treatments tested in this trial
Third molar surgery
Procedure/SurgeryDuring 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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Curasept DNA ADS periodontal gelExperimental treatment 1 intervention
Group B: Placebo gel wound dressingPlacebo comparator 1 intervention
Trial outcomes
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
Time frame
From enrollment to the end of treatment at 2 weeksSecondary outcomes
1
Mouth opening
Time frame
From enrollment to the end of treatment at 2 weeks2
Subjective pain level
Visual Analogue Scale (VAS) 0-10: the higher number indicates the more intense pain.
Time frame
From enrollment to the end of treatment at 2 weeks3
Face swelling
Time frame
From enrollment to the end of treatment at 2 weeks4
Taken analgesics (questionaire)
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.
Time frame
From enrollment to the end of treatment at 2 weeksOther outcomes
1
Probing pocket depth
second molar
Time frame
From enrollment to the end of treatment at 2 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
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