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

NCT04200885 | Completed Phase 4

• 1 other identifier: 19-KAEK-100
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Third Molar Surgery

Keywords

Dexamethasone; Applied Kinesiology; Non-Steroidal Anti-Inflammatory Agents; Teeth, Impacted; Edema; Trismus; Postoperative Pain

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (3)

• Wound Healing Scores

  Postoperative second and seventh days.

• Oral Health Impact Profile

  Preoperatively on the day of surgery, postoperative second and seventh days.

• Postoperative Symptom Severity Evaluation

  Postoperative seventh day.

Study Arms (3)

Postoperative NSAID Prescription

ACTIVE COMPARATOR

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

Preoperative Submucosal Corticosteroid Injection

ACTIVE COMPARATOR

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

Postoperative Therapeutic Elastic Bandage Application

ACTIVE COMPARATOR

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

Interventions

Dexketoprofen Trometamol DRUG

Patients were instructed to record the number of drugs they used until the second and seventh postoperative days.

Also known as: Arveles 25 mg 20 tablets

Postoperative NSAID Prescription

Dexamethasone 21-Phosphate DRUG

Injections were administered in the immediate preoperative period as a single shot.

Also known as: Dekort 8mg/2ml Intramuscular (IM)/ Intravenous (IV)

Preoperative Submucosal Corticosteroid Injection

Therapeutic Elastic Bandage DEVICE

The bands' lengths were individually measured and divided into five equal parts up to 2/3 of their lengths to obtain fan-type shape.

Also known as: Kinesio Tex Gold Fingerprint (FP)

Postoperative Therapeutic Elastic Bandage Application

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Tokat Gaziosmanpasa University: lead

Study Sites (1)

Tokat Gaziosmanpasa University, Faculty of Dentistry

Tokat Province, 60100, Turkey (Türkiye)

Location

Related Publications (4)

• 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.

  PMID: 23963616 BACKGROUND

• 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.

  PMID: 23810681 BACKGROUND

• 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.

  PMID: 27752209 BACKGROUND

• 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.

  PMID: 32803439 DERIVED

MeSH Terms

Conditions

Tooth, Impacted; Edema; Trismus; Pain, Postoperative

Interventions

dexketoprofen trometamol; dexamethasone 21-phosphate; Injections, Intramuscular

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spasm; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pain

Intervention Hierarchy (Ancestors)

Injections; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Nihat Akbulut, Assoc. Dr.

  Tokat Gaziosmanpasa University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Model Details: 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.

Study Record Dates

• First Submitted: December 8, 2019
• First Posted: December 16, 2019
• Study Start: May 2, 2019
• Primary Completion: August 26, 2019
• Study Completion: November 21, 2019
• Last Updated: December 17, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: The study will be transformed to an article in six months.
• Access Criteria: All IPD and supporting information data will be accessible after publication of the article

Locations

TU (1)