Is Therapeutic Elastic Bandage As Effective As Corticosteroids Following Third Molar Surgery?

T

Tokat Gaziosmanpasa University

Status and phase

Completed
Phase 4

Conditions

Third Molar Surgery

Treatments

Drug: Dexamethasone 21-Phosphate
Drug: Dexketoprofen Trometamol
Device: Therapeutic Elastic Bandage

Study type

Interventional

Funder types

Other

Identifiers

NCT04200885
19-KAEK-100

Details and patient eligibility

About

In this study; Among the patients randomized because of severe postoperative sequelae expected as a result of radiological and clinical examinations; nonsteroid antiinflammatory drug prescribed group compared with preoperative single dose intraoral submucosal corticosteroid administration and therapeutic elastic bandage application considering inflammatory symptoms' severity and health related quality of life following surgical removal of impacted third molars. The study hypothesis was formed stating that corticosteroid injection and elastic bandage application would reduce the inflammatory symptoms more than NSAID.

Enrollment

52 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Age between 18-65 years
  • American Society of Anesthesiologists (ASA) Class 1 physiological status
  • Consistent radiological and clinical data
  • Volunteered to participate in the study
  • Surgical difficulty score above 5 which was determined according to Pederson scale.

Exclusion criteria

  • Being out of age range
  • Analgesic or antibiotic therapy history in last 30 days due to symptoms of related third molar
  • Smoking cigarette
  • Any pathology associated with impacted third molar
  • Active complaints on preoperative examination on the day of surgery
  • Immunosuppressed or diagnosed with malignancy
  • Diagnosed chronic diseases such as; Diabetes mellitus (DM), hypertension, cerebrovascular event, psychiatric diseases, coagulopathies
  • Autoimmune diseases
  • If total operation time exceeds 45 minutes
  • Patients who could not attend regular follow-up visits
  • Allergy to the medications prescribed or utilized in study protocol
  • Inconsistent clinical and radiological data

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

52 participants in 3 patient groups

Postoperative NSAID Prescription
Active Comparator group
Description:
Patients in this arm received common postoperative prescriptions following removal of their impacted third molars for seven days; twice a day 500 mg amoxicillin+125 mg clavulanic acid, twice a day 25 mg dexketoprofen trometamol and three times a day 1.5 mg/ml clorhexidine gluconate+1.2 mg/ml benzydamine hydrochloride containing 200 ml mouthwash.
Treatment:
Drug: Dexketoprofen Trometamol
Preoperative Submucosal Corticosteroid Injection
Active Comparator group
Description:
Patients in this arm were administered 8mg/2ml dexamethasone 21-phosphate preoperatively after local anesthesia were obtained. Injection site was the depth of buccal sulcus near operation site. For the patients in this arm 25 mg dexketoprofen trometamol was excluded from postoperative prescription in order not to affect the anti-inflammatory effects of corticosteroid. Instead of NSAID, three times a day 500 mg paracetamol was prescribed. The patients were advised not to exceed maximal dosage of 3000 mg (6 tablets) in a day.
Treatment:
Drug: Dexamethasone 21-Phosphate
Postoperative Therapeutic Elastic Bandage Application
Active Comparator group
Description:
In this arm the therapeutic elastic bandage applications were immediately performed after removal of mandibular third molars. The distance between tragus-lateral commissura line and supraclavicular lymph nodes was measured and the tapes were then cut into 5 tails. The base of the tape was placed on supraclavicular lymph nodes and tails were placed on the site to cover parotid, submandibular, submental and superficial cervical lymph nodes. The tapes were removed on postoperative second day.
Treatment:
Device: Therapeutic Elastic Bandage

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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