Is Therapeutic Elastic Bandage As Effective As Corticosteroids Following Third Molar Surgery?
NCT ID: NCT04200885
Last Updated: 2019-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
52 participants
INTERVENTIONAL
2019-05-02
2019-11-21
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Postoperative NSAID Prescription
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.
Dexketoprofen Trometamol
Patients were instructed to record the number of drugs they used until the second and seventh postoperative days.
Preoperative Submucosal Corticosteroid Injection
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.
Dexamethasone 21-Phosphate
Injections were administered in the immediate preoperative period as a single shot.
Postoperative Therapeutic Elastic Bandage Application
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.
Therapeutic Elastic Bandage
The bands' lengths were individually measured and divided into five equal parts up to 2/3 of their lengths to obtain fan-type shape.
Interventions
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Dexketoprofen Trometamol
Patients were instructed to record the number of drugs they used until the second and seventh postoperative days.
Dexamethasone 21-Phosphate
Injections were administered in the immediate preoperative period as a single shot.
Therapeutic Elastic Bandage
The bands' lengths were individually measured and divided into five equal parts up to 2/3 of their lengths to obtain fan-type shape.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
Yes
Sponsors
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Tokat Gaziosmanpasa University
OTHER
Responsible Party
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Aras Erdil
Research Assistant
Principal Investigators
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Nihat Akbulut, Assoc. Dr.
Role: STUDY_DIRECTOR
Tokat Gaziosmanpasa University
Locations
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Tokat Gaziosmanpasa University, Faculty of Dentistry
Tokat Province, , Turkey (Türkiye)
Countries
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References
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Ristow O, Hohlweg-Majert B, Sturzenbaum SR, Kehl V, Koerdt S, Hahnefeld L, Pautke C. Therapeutic elastic tape reduces morbidity after wisdom teeth removal--a clinical trial. Clin Oral Investig. 2014 May;18(4):1205-1212. doi: 10.1007/s00784-013-1067-3. Epub 2013 Aug 21.
Alcantara CE, Falci SG, Oliveira-Ferreira F, Santos CR, Pinheiro ML. Pre-emptive effect of dexamethasone and methylprednisolone on pain, swelling, and trismus after third molar surgery: a split-mouth randomized triple-blind clinical trial. Int J Oral Maxillofac Surg. 2014 Jan;43(1):93-8. doi: 10.1016/j.ijom.2013.05.016. Epub 2013 Jun 28.
Deo SP. Single-Dose of Submucosal Injection of Dexamethasone Affects the Post Operative Quality of Life After Third Molar Surgery. J Maxillofac Oral Surg. 2016 Sep;15(3):367-375. doi: 10.1007/s12663-015-0846-6. Epub 2015 Dec 7.
Erdil A, Akbulut N, Altan A, Demirsoy MS. Comparison of the effect of therapeutic elastic bandage, submucosal dexamethasone, or dexketoprofen trometamol on inflammatory symptoms and quality of life following third molar surgery: a randomized clinical trial. Clin Oral Investig. 2021 Apr;25(4):1849-1857. doi: 10.1007/s00784-020-03487-y. Epub 2020 Aug 15.
Other Identifiers
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19-KAEK-100
Identifier Type: -
Identifier Source: org_study_id