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

Primary Purpose

Third Molar Surgery

Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Dexketoprofen Trometamol
Dexamethasone 21-Phosphate
Therapeutic Elastic Bandage
Sponsored by
Tokat Gaziosmanpasa University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Third Molar Surgery focused on measuring Dexamethasone, Applied Kinesiology, Non-Steroidal Anti-Inflammatory Agents, Teeth, Impacted, Edema, Trismus, Postoperative Pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Tokat Gaziosmanpasa University, Faculty of Dentistry

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Postoperative NSAID Prescription

Preoperative Submucosal Corticosteroid Injection

Postoperative Therapeutic Elastic Bandage Application

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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 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 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.
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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
December 8, 2019
Last Updated
December 13, 2019
Sponsor
Tokat Gaziosmanpasa University
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1. Study Identification

Unique Protocol Identification Number
NCT04200885
Brief Title
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

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
May 2, 2019 (Actual)
Primary Completion Date
August 26, 2019 (Actual)
Study Completion Date
November 21, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tokat Gaziosmanpasa University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Third Molar Surgery
Keywords
Dexamethasone, Applied Kinesiology, Non-Steroidal Anti-Inflammatory Agents, Teeth, Impacted, Edema, Trismus, Postoperative Pain

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Postoperative NSAID Prescription
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Preoperative Submucosal Corticosteroid Injection
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Postoperative Therapeutic Elastic Bandage Application
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Dexketoprofen Trometamol
Other Intervention Name(s)
Arveles 25 mg 20 tablets
Intervention Description
Patients were instructed to record the number of drugs they used until the second and seventh postoperative days.
Intervention Type
Drug
Intervention Name(s)
Dexamethasone 21-Phosphate
Other Intervention Name(s)
Dekort 8mg/2ml Intramuscular (IM)/ Intravenous (IV)
Intervention Description
Injections were administered in the immediate preoperative period as a single shot.
Intervention Type
Device
Intervention Name(s)
Therapeutic Elastic Bandage
Other Intervention Name(s)
Kinesio Tex Gold Fingerprint (FP)
Intervention Description
The bands' lengths were individually measured and divided into five equal parts up to 2/3 of their lengths to obtain fan-type shape.
Primary Outcome Measure Information:
Title
Preoperative Pain Intensity
Description
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.
Time Frame
On the day of surgery preoperatively
Title
Change From Baseline Maximal Mouth Opening on Postoperative Follow Up Visits
Description
All patients' maximal mouth opening were measured and recorded as the distance between upper and lower right central incisors.
Time Frame
Preoperatively on the day of surgery, postoperative second and seventh days.
Title
Change From Baseline Facial Measurements on Postoperative Follow Up Visits
Description
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.
Time Frame
Preoperatively on the day of surgery, postoperative second and seventh days.
Title
Oral Analgesic Consumption-1
Description
The patients were asked to record the amounts of consumed analgesic tablets (tablets per day) until first follow up visit.
Time Frame
Postoperative Second Day
Title
Postoperative Pain Intensity-1
Description
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.
Time Frame
Postoperative Second Day
Title
Postoperative Pain Intensity-2
Description
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.
Time Frame
Postoperative Seventh Day
Title
Oral Analgesic Consumption-2
Description
The patients were asked to record the amounts of consumed analgesic tablets (tablets per day) between first and last follow up visits.
Time Frame
Postoperative Seventh Day
Secondary Outcome Measure Information:
Title
Wound Healing Scores
Description
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.
Time Frame
Postoperative second and seventh days.
Title
Oral Health Impact Profile
Description
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.
Time Frame
Preoperatively on the day of surgery, postoperative second and seventh days.
Title
Postoperative Symptom Severity Evaluation
Description
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.
Time Frame
Postoperative seventh day.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nihat Akbulut, Assoc. Dr.
Organizational Affiliation
Tokat Gaziosmanpasa University
Official's Role
Study Director
Facility Information:
Facility Name
Tokat Gaziosmanpasa University, Faculty of Dentistry
City
Tokat
ZIP/Postal Code
60100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
Citations:
PubMed Identifier
23963616
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.
Results Reference
background
PubMed Identifier
23810681
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.
Results Reference
background
PubMed Identifier
27752209
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.
Results Reference
background
PubMed Identifier
32803439
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.
Results Reference
derived

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

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