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

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Primary Purpose

Status

Completed

Phase

Phase 4

Locations

Turkey

Study Type

Interventional

Intervention

Dexketoprofen Trometamol

Dexamethasone 21-Phosphate

Therapeutic Elastic Bandage

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

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

NCT ID

NCT04200885

First Posted

December 8, 2019

Last Updated

December 13, 2019

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