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The aim of this randomized double-blind cross over clinical trial is to investigate effectiveness of different routes of applications (intramuscular and submucous at the site of surgery) and doses (4 mg and 8 mg) of Dexamethasone on swelling, trismus, pain and quality of life after lower third molar surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intramuscular application | Active Comparator | Intramuscular application of 4mg Dexamethasone |
|
| Submucosal application | Experimental | Submucosal application of 4mg Dexamethasone |
|
| 4mg Dexamethasone submucosal | Active Comparator | 4mg Dexamethasone submucosal application |
|
| 8mg Dexamethasone submucosal | Experimental | 8mg Dexamethasone submucosal application |
|
| 4mg Dexamethasone postoperative | Active Comparator | 4mg Dexamethasone postoperative application |
|
| 4mg Dexamethasone preoperative | Experimental | 4mg Dexamethasone postoperative application |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intramuscular application | Procedure | Patient receive 4mg of Dexamethasone by intramuscular application |
|
| Measure | Description | Time Frame |
|---|---|---|
| Facial swelling (using 3 facial measurements (in millimeters) | We followed facial swelling 1, 3 and 7 days after intervention. Swelling in the operation site will be evaluated using 3 facial measurements (in millimeters):
| 1 day, 3 day, 7 day |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative pain (visual analog scale) | Postoperative pain will be evaluated using a visual analog scale, 100 mm in length ranging from 0 for " no pain" to 100 for "the worse imaginable pain". | 1 day, 3 day, 7 day |
| Postoperative trismus (difference in interincisal distance at the maximal mouth opening (in millimeters) before and after surgery) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Miroslav M Andric, DDS, PhD | University of Zagreb | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| School of Dental Medicine | Belgrade | 11000 | Serbia |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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|
| Submucosal application | Procedure | Patients receive 4mg of Dexamethasone by submucosal application |
|
| 4mg Dexamethasone submucosal | Drug | Patients receive 4mg of submucosal Dexamethasone |
|
|
| 8mg Dexamethasone submucosal | Drug | Patients receive 8mg of submucosal Dexamethasone |
|
|
| 4mg Dexamethasone preoperative | Procedure | Patients receive 4mg of Dexamethasone preoperatively |
|
| 4mg Dexamethasone postoperative | Procedure | Patients receive 4mg of Dexamethasone postoperatively |
|
Postoperative trismus will be measured as the difference in interincisal distance at the maximal mouth opening (in millimeters) before and after surgery. |
| 1 day, 3 day, 7 day |
| Postoperative discomfort (25-items custom made questionnaire) | Postoperative discomfort will be evaluated by filling out the 25-items custom made questionnaire that was designed to asses the patient's perception of adverse effects. | 4 day, 7 day |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |