Dept. of Oral and Maxillofacial Surgery, UP
Pécs, 7623, Hungary
NCT Number: NCT07044219
Our aim is to evaluate chlorhexidine-hyaluronic acid containing gel on postoperative wound healing regarding impacted lower third molar surgery.
Trial opening soon.
Get Notified18 year–99 year
All sexes
Interventional
Not applicable
Pécs, 7623, Hungary
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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
Time frame: From enrollment to the end of treatment at 2 weeks
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.
Time frame: From enrollment to the end of treatment at 2 weeks
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.
Time frame: From enrollment to the end of treatment at 2 weeks
second molar
Contact information is provided by the study sponsor or research team.
Balázs Soós, PhD
CONTACT
József Szalma, Prof, PhD, DSc
CONTACT
University of Pecs
Other
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
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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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