Is Therapeutic Elastic Bandage As Effective As Corticosteroids Following Third Molar Surgery?
- Conditions
- Third Molar Surgery
- Interventions
- Registration Number
- NCT04200885
- Lead Sponsor
- Tokat Gaziosmanpasa University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 52
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Preoperative Submucosal Corticosteroid Injection Dexamethasone 21-Phosphate 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. Postoperative NSAID Prescription Dexketoprofen Trometamol 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. Postoperative Therapeutic Elastic Bandage Application Therapeutic Elastic Bandage 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.
- Primary Outcome Measures
Name Time Method Postoperative Pain Intensity-2 Postoperative Seventh Day 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.
Change From Baseline Maximal Mouth Opening on Postoperative Follow Up Visits Preoperatively on the day of surgery, postoperative second and seventh days. 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 Preoperatively on the day of surgery, postoperative second and seventh days. 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 Postoperative Second Day The patients were asked to record the amounts of consumed analgesic tablets (tablets per day) until first follow up visit.
Oral Analgesic Consumption-2 Postoperative Seventh Day The patients were asked to record the amounts of consumed analgesic tablets (tablets per day) between first and last follow up visits.
Postoperative Pain Intensity-1 Postoperative Second Day 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.
Preoperative Pain Intensity On the day of surgery preoperatively 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.
- Secondary Outcome Measures
Name Time Method Oral Health Impact Profile Preoperatively on the day of surgery, postoperative second and seventh days. 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 seventh day. 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.
Wound Healing Scores Postoperative second and seventh days. 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.
Trial Locations
- Locations (1)
Tokat Gaziosmanpasa University, Faculty of Dentistry
🇹🇷Tokat, Turkey