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| ID | Type | Description | Link |
|---|---|---|---|
| Sue010401262 | Other Identifier | Al Salam University |
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This study evaluated whether giving a single dose of long-acting corticosteroids before wisdom tooth surgery reduces pain, facial swelling, and limited jaw opening (trismus) after surgery. Adult patients aged 18-35 undergoing impacted lower wisdom tooth removal were randomly assigned to receive either 8 mg dexamethasone or a placebo before surgery. Pain, swelling, and jaw mobility were measured at several time points after surgery. The study aimed to determine if preoperative corticosteroids improve recovery and reduce discomfort following surgery.
Surgical removal of impacted lower wisdom teeth often causes pain, swelling, and reduced jaw opening (trismus) due to tissue inflammation. This study examined whether giving a single dose of long-acting corticosteroids before surgery could reduce these postoperative problems.
Adult patients aged 18-35 years who required surgical extraction of impacted mandibular third molars were randomly assigned to receive either 8 mg dexamethasone (treatment group) or a placebo (control group) 30 minutes before surgery. The study measured pain using a visual analog scale, facial swelling with standard facial landmarks, and jaw opening with calipers at multiple time points after surgery. Analgesic consumption was also recorded.
The goal was to determine whether preoperative corticosteroid administration could improve recovery, reduce discomfort, and enhance patient comfort after third molar surgery. This information may help guide oral surgeons in postoperative care and improve outcomes for patients undergoing similar procedures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexamethasone Group (Treatment) | Experimental | Participants receive a single dose of 8 mg dexamethasone administered intramuscularly 30 minutes before impacted mandibular third molar surgery. This intervention is intended to reduce postoperative pain, facial swelling, and limited jaw opening (trismus). Participants, care providers, investigators, and outcome assessors are blinded to group allocation. |
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| Placebo Group (Control) | Placebo Comparator | Participants receive a single dose of normal saline (placebo) administered intramuscularly 30 minutes before impacted mandibular third molar surgery. This arm serves as the control group for comparison with the dexamethasone group. Blinding is maintained for participants, care providers, investigators, and outcome assessors. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone 8 mg IM | Drug | Patients receive a single intramuscular injection of 8 mg dexamethasone 30 minutes before surgical removal of impacted mandibular third molars. This intervention is intended to reduce postoperative pain, facial swelling, and trismus. No additional steroids are allowed postoperatively. |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative pain | Postoperative pain will be assessed using the Visual Analog Scale (VAS), a 10-cm horizontal line ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable. Higher scores indicate greater pain intensity. | 6, 24, 48, and 72 hours postoperatively. |
| Facial Swelling Measured by Linear Facial Measurements (Tragus-Pogonion and Gonion-Lateral Canthus Distances) | Facial swelling will be assessed using standardized linear facial measurements between anatomical landmarks (tragus to pogonion and gonion to lateral canthus) using a flexible measuring tape. Measurements will be recorded in millimeters (mm). An increase in distance compared to preoperative values indicates greater facial swelling. | Preoperatively, Day 2, and Day 7 postoperatively |
| Trismus (Maximum interincisal opening) | Trismus will be measured by maximum interincisal mouth opening using calipers. | Preoperatively, Day 2, and Day 7 postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Analgesic consumption | Total number of rescue analgesic tablets (ibuprofen 400 mg) taken postoperatively. | Postoperative days 1-7 |
| Number of rescue analgesic tablets taken | Number of additional analgesic tablets consumed by each participant after surgery. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Omaima M Sakr, BDS, MSc, PhD | Al Salam University, Faculty of Oral & Dental Medicine, Egypt | Principal Investigator |
| Ahmed K Fawzi, BDS, MSc, PhD | Al Salam University, Faculty of Oral & Dental Medicine, Egypt | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Oral & Maxillofacial Surgery, Al Salam University | Tanta | Gharbia Governorate | Egypt |
The individual participant data (IPD) will not be shared outside the study team due to privacy and confidentiality considerations.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol: Main Protocol | Jan 4, 2026 | Feb 13, 2026 |
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Participants are randomly assigned to receive either preoperative intramuscular dexamethasone or placebo before impacted mandibular third molar surgery, and outcomes are compared between both groups.
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Participants, care providers, investigators, and outcome assessors were blinded to group allocation. Identical syringes were prepared by an independent clinician not involved in treatment or outcome assessment.
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| Normal Saline IM | Drug | Patients receive a single intramuscular injection of 2 mL normal saline 30 minutes before surgical removal of impacted mandibular third molars. This placebo control is used to compare the effect of preoperative dexamethasone on postoperative pain, facial swelling, and trismus. |
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| Postoperative days 1-7 |
| Prot_000.pdf |
| Prot | Yes | No | No | Study Protocol: Ethics Approval Letter | Jan 4, 2026 | Feb 13, 2026 | Prot_001.pdf |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D014313 | Trismus |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013035 | Spasm |
| D020879 | Neuromuscular Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
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