Clinical trial NCT04200885: Is Therapeutic Elastic Bandage As Effective As Corticosteroids Following Third Molar Surgery?
Official title: Comparison Of The Effectiveness Of Submucosal Corticosteroid Injection And Elastic Therapeutic Bandage Applications On Pain, Swelling And Trismus After Surgical Removal Of Mandibular Third Molar Teeth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Third Molar Surgery
Keywords: Dexamethasone
Applied Kinesiology
Non-Steroidal Anti-Inflammatory Agents
Teeth, Impacted
Edema
Trismus
Postoperative Pain
Lead sponsor: Tokat Gaziosmanpasa University
Sponsor class: OTHER
First posted: 2019-12-16
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Among the patients randomized because of severe postoperative sequelae expected as a result of radiological examination prior to surgical extraction of lower third molar teeth; postoperatively nonsteroid antiinflammatory drug prescribed group compared with preoperative single dose intraoral submucosal corticosteroid administration and postoperative therapeutic elastic bandage application.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Preoperative Pain Intensity
timeFrame: On the day of surgery preoperatively
measure: Change From Baseline Maximal Mouth Opening on Postoperative Follow Up Visits
timeFrame: Preoperatively on the day of surgery, postoperative second and seventh days.
measure: Change From Baseline Facial Measurements on Postoperative Follow Up Visits
timeFrame: Preoperatively on the day of surgery, postoperative second and seventh days.
measure: Oral Analgesic Consumption-1
timeFrame: Postoperative Second Day
measure: Postoperative Pain Intensity-1
timeFrame: Postoperative Second Day
measure: Postoperative Pain Intensity-2
timeFrame: Postoperative Seventh Day
measure: Oral Analgesic Consumption-2
timeFrame: Postoperative Seventh Day
Secondary outcomes:
measure: Wound Healing Scores
timeFrame: Postoperative second and seventh days.
measure: Oral Health Impact Profile
timeFrame: Preoperatively on the day of surgery, postoperative second and seventh days.
measure: Postoperative Symptom Severity Evaluation
timeFrame: Postoperative seventh day.
Other outcomes:
Locations:
city: Tokat
country: Turkey
facility: Tokat Gaziosmanpasa University, Faculty of Dentistry
Study officials:
affiliation: Tokat Gaziosmanpasa University
name: Nihat Akbulut, Assoc. Dr.
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.