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

Third Molar Surgery Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04200885
• Other study ID #: 19-KAEK-100
• Status: Completed
• Phase: Phase 4
• Start date: May 2, 2019
• Est. completion date: November 21, 2019

Study information

• Verified date: December 2019
• Source: Tokat Gaziosmanpasa University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: November 21, 2019
• Est. primary completion date: August 26, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Third Molar Surgery
• Trismus

Intervention

Drug:
• 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.

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.

Locations

Country	Name	City	State
Turkey	Tokat Gaziosmanpasa University, Faculty of Dentistry	Tokat

Sponsors (1)

Lead Sponsor	Collaborator
Tokat Gaziosmanpasa University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

Alcântara 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. — View 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. Epub 2015 Dec 7. — View Citation

Ristow O, Hohlweg-Majert B, Stürzenbaum 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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.
Primary	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.
Primary	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
Primary	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
Primary	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
Primary	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	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.
Secondary	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.
Secondary	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.