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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Third Molar Surgery

Intervention / Treatment
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* Drug: Dexketoprofen Trometamol
* Drug: Dexamethasone 21-Phosphate
* Device: Therapeutic Elastic Bandage


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Postoperative NSAID Prescription<br>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<br>* Patients were instructed to record the number of drugs they used until the second and seventh postoperative days.<br>* Other names: Arveles 25 mg 20 tablets;|
| Active Comparator: Preoperative Submucosal Corticosteroid Injection<br>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<br>* Injections were administered in the immediate preoperative period as a single shot.<br>* Other names: Dekort 8mg/2ml Intramuscular (IM)/ Intravenous (IV);|
| Active Comparator: Postoperative Therapeutic Elastic Bandage Application<br>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<br>* The bands' lengths were individually measured and divided into five equal parts up to 2/3 of their lengths to obtain fan-type shape.<br>* Other names: Kinesio Tex Gold Fingerprint (FP);|

What is the study measuring?
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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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dexamethasone, Applied Kinesiology, Non-Steroidal Anti-Inflammatory Agents, Teeth, Impacted, Edema, Trismus, Postoperative Pain