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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Postoperative NSAID Prescription | Active Comparator | 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. |
|
| Preoperative Submucosal Corticosteroid Injection | Active Comparator | 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. |
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| Postoperative Therapeutic Elastic Bandage Application | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexketoprofen Trometamol | Drug | Patients were instructed to record the number of drugs they used until the second and seventh postoperative days. |
|
| 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nihat Akbulut, Assoc. Dr. | Tokat Gaziosmanpasa University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tokat Gaziosmanpasa University, Faculty of Dentistry | Tokat Province | 60100 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23963616 | Background | 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. | |
| 23810681 | Background | 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. |
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All individual participant data (IPD) related to study protocol and results will be shared during submitting as an article.
The study will be transformed to an article in six months.
All IPD and supporting information data will be accessible after publication of the article
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| ID | Term |
|---|---|
| D014095 | Tooth, Impacted |
| D004487 | Edema |
| D014313 | Trismus |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C118296 | dexketoprofen trometamol |
| C004180 | dexamethasone 21-phosphate |
| D007273 | Injections, Intramuscular |
| ID | Term |
|---|---|
| D007267 | Injections |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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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.
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|
| Dexamethasone 21-Phosphate | Drug | Injections were administered in the immediate preoperative period as a single shot. |
|
|
| Therapeutic Elastic Bandage | Device | The bands' lengths were individually measured and divided into five equal parts up to 2/3 of their lengths to obtain fan-type shape. |
|
|
| 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 |
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. |
| 27752209 | Background | 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. |
| 32803439 | Derived | 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. |
| D013035 | Spasm |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D010146 | Pain |