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

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

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.

Study Overview

• Status: Completed
• Conditions: Third Molar Surgery
• Intervention / Treatment: Drug: Dexketoprofen Trometamol; Drug: Dexamethasone 21-Phosphate; Device: Therapeutic Elastic Bandage

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Phase 4

Contacts and Locations

Study Locations

• Turkey
  • Tokat, Turkey, 60100
    • Tokat Gaziosmanpasa University, Faculty of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Drug: Dexketoprofen Trometamol; Patients were instructed to record the number of drugs they used until the second and seventh postoperative days.; Other Names: Arveles 25 mg 20 tablets
Active Comparator: 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.	Drug: Dexamethasone 21-Phosphate; Injections were administered in the immediate preoperative period as a single shot.; Other Names: Dekort 8mg/2ml Intramuscular (IM)/ Intravenous (IV)
Active Comparator: 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.	Device: 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 Names: Kinesio Tex Gold Fingerprint (FP)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Preoperative Pain Intensity	The patients were asked to mark their pain intensities on a Numerical Rating Scale in which '0' means no pain, '5' means moderate pain and '10' means worst imaginable pain on the day of surgery preoperatively.	On the day of surgery preoperatively
Change From Baseline Maximal Mouth Opening on Postoperative Follow Up Visits	All patients' maximal mouth opening were measured and recorded as the distance between upper and lower right central incisors.	Preoperatively on the day of surgery, postoperative second and seventh days.
Change From Baseline Facial Measurements on Postoperative Follow Up Visits	Measurements were performed on the ipsilateral site between tragus and lateral commissura, lateral canthus and angle of mandible with a flexible ruler. The obtained values' average amounts were calculated and recorded for each patient.	Preoperatively on the day of surgery, postoperative second and seventh days.
Oral Analgesic Consumption-1	The patients were asked to record the amounts of consumed analgesic tablets (tablets per day) until first follow up visit.	Postoperative Second Day
Postoperative Pain Intensity-1	The patients were asked to mark their pain intensities on a Numerical Rating Scale in which '0' means no pain, '5' means moderate pain and '10' means worst imaginable pain.	Postoperative Second Day
Postoperative Pain Intensity-2	The patients were asked to mark their pain intensities on a Numerical Rating Scale in which '0' means no pain, '5' means moderate pain and '10' means worst imaginable pain.	Postoperative Seventh Day
Oral Analgesic Consumption-2	The patients were asked to record the amounts of consumed analgesic tablets (tablets per day) between first and last follow up visits.	Postoperative Seventh Day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wound Healing Scores	Extraction wound healing rates were evaluated by Landry's healing index. The index scores were classified as; 1. Very poor, 2. Poor, 3. Good, 4. Very Good and 5. Excellent.	Postoperative second and seventh days.
Oral Health Impact Profile	Oral health-related quality of life was followed up with Oral Health Impaction Profile-14 questionnaire (Turkish Version). The investigators aimed to detect the alterations in quality of life due to surgical intervention and the other treatment modalities. The obtainable scores vary between 0-56 points. Lower scores indicate better postoperative physical and psychological conditions.	Preoperatively on the day of surgery, postoperative second and seventh days.
Postoperative Symptom Severity Evaluation	Postoperative inflammatory symptoms were evaluated with the postoperative symptom severity scale at the end of the follow-up period individually. The scale scores vary between 0%-100%. The higher scores indicate that the individual experienced severe symptoms. The investigators aimed to detect the severity of symptoms from the point of the patient's view.	Postoperative seventh day.

Collaborators and Investigators

• Sponsor: Tokat Gaziosmanpasa University
• Investigators: Study Director: Nihat Akbulut, Assoc. Dr., Tokat Gaziosmanpasa University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 2, 2019
• Primary Completion (Actual): August 26, 2019
• Study Completion (Actual): November 21, 2019

Study Registration Dates

• First Submitted: December 8, 2019
• First Submitted That Met QC Criteria: December 13, 2019
• First Posted (Actual): December 16, 2019

Study Record Updates

• Last Update Posted (Actual): December 17, 2019
• Last Update Submitted That Met QC Criteria: December 13, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: Postoperative Pain; Edema; Dexamethasone; Applied Kinesiology; Trismus; Non-Steroidal Anti-Inflammatory Agents; Teeth, Impacted
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neuromuscular Manifestations; Spasm; Trismus; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Dexamethasone; Dexamethasone 21-phosphate; Dexketoprofen trometamol
• Other Study ID Numbers: 19-KAEK-100

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: All individual participant data (IPD) related to study protocol and results will be shared during submitting as an article.
• IPD Sharing Time Frame: The study will be transformed to an article in six months.
• IPD Sharing Access Criteria: All IPD and supporting information data will be accessible after publication of the article
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No