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This study aims to compare the effectiveness of 4mg and 8mg dexamethasone administered submucosally in reducing postoperative pain after dental implant surgery. Participants will be randomly assigned to receive either 4mg dexamethasone, 8mg dexamethasone, or a placebo (normal saline) at the surgical site.
Later, postoperative pain will be assessed using a Visual Analog Scale at 6 hours after the surgery and daily for the next 6 days. Also the number of pain-relief tablets consumed after the surgery will be recorded.
Preoperative anxiety will be assessed using Generalized Anxiety Disorder-7 (GAD-7) questionnaire to assess its association with postoperative pain scores.
The results of this study will help determine the optimal dose of dexamethasone that is effective for postoperative pain control following dental implant surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 8mg Dexamethasone | Experimental | 8mg/2ml dexamethasone injection. |
|
| 4mg Dexamethasone | Experimental | 4mg/1ml Dexamethasone ampoule + 1ml of sterile normal saline for injection. Mixing dexamethasone with sterile normal saline for injection is considered safe and has no effect on drug potency and efficacy based on current evidence. |
|
| Placebo | Placebo Comparator | 2 ml of sterile normal saline for injection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone 4 Mg/mL Injectable Solution | Drug | Syringe will be concealed. Submucosal injection will be adjacent to the surgical site in the buccal vestibule |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative pain assessed using Visual Analog Scale (VAS) | Postoperative pain will be assessed using a 10-cm visual analog scale in patients following single dental implant surgery after submucosal administration of dexamethasone or placebo | at 6 hours postoperatively and then once daily for the following 6 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of postoperative analgesic tablets consumed | The total number of rescue analgesic tablets consumed postoperatively will be recorded daily following the implant surgery | Postoperatively for 7 days |
| Correlation between preoperative anxiety (GAD-7) and postoperative pain score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shurooq Slim Al Hinai, BDS | Contact | +968 96148103 | shurooqalhinai@gmail.com | |
| Nasser Al Khaldi, Senior Consultant Prosth | Contact | + 968 92898987 | dent2020@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Al Nahdha Hospital | Recruiting | Muscat | Oman |
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| Dexamethasone 8Mg Solution for Injection | Drug | Syringe will be concealed. Submucosal injection will be adjacent to the surgical site in the buccal vestibule |
|
| Saline (NaCl 0,9 %) (placebo) | Drug | Syringe will be concealed. Submucosal injection will be adjacent to the surgical site in the buccal vestibule |
|
Anxiety will be assessed preoperatively using Generalized Anxiety Disorder-7 questionnaire. The relationship between preoperative anxiety scores and postoperative VAS following dental implant surgery will evaluated. |
| Anxiety will be assessed preoperatively on the day of the surgery before implant placement |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| D012996 | Solutions |
| D007267 | Injections |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D004364 | Pharmaceutical Preparations |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
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