Dry Socket, Postoperative Infections
Conditions
Keywords
alveolitis, dry socket, dehiscence
Brief summary
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
PROCEDUREThird 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 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.
Sponsors
University of Pecs
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wound healing | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | Visual Analogue Scale (VAS) 0-10: the higher number indicates the more intense pain. |
| 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Probing pocket depth | From enrollment to the end of treatment at 2 weeks | second molar |
Countries
Hungary
Contacts
Primary ContactJózsef Szalma, Prof, PhD, DSc
Backup ContactBalázs Soós, PhD
Outcome results
None listed