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Background and aim: Postoperative pain is an adverse effect of oral surgeries and may therefore be prevented or minimized. This study compares the efficacy of preemptive ibuprofen and dexamethasone protocols in pain prevention and control after surgical implant placement.
Methods: For this prospective, double-masked, parallel-group, placebo-controlled, randomized clinical trial, 117 dental implants were placed. The groups received three different protocols 1 hour before surgery:
Rescue medication (1000 mg acetaminophen) was given to each patient who was instructed to take it if necessary. Pain intensity was evaluated by a 101-point numeric rate scale and visual analogue scale, additionally discomfort was evaluated using a four-point verbal rate scale, hourly for the first 8 hours after surgery and three times a day on the following 3 days.
This prospective clinical trial investigated the efficacy of preemptive medication in mitigating postoperative pain following dental implant surgeries. With a sample size of 117 participants, the study employed a double-masked, parallel-group, placebo-controlled design. Patients were randomly assigned to receive one of three treatment protocols-an ibuprofen regimen, a dexamethasone regimen, or a placebo-administered one hour before surgery. Pain intensity and discomfort were assessed using numeric, visual, and verbal scales hourly for the first 8 hours post-surgery, followed by thrice-daily evaluations for the next 3 days. Additionally, rescue medication (acetaminophen) was provided to manage pain as needed. The study aimed to determine whether ibuprofen or dexamethasone could effectively alleviate postoperative pain compared to a placebo to highlight optimal pain management strategies for dental implant procedures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1- Received Ibuprofen (N=44) | Active Comparator | This group receives 1 hour before surgery 600 mg ibuprofen (and another 600 mg dose 6 hours after the first dose). Acetaminophen 1000 mg: A Rescue medication (1000 mg acetaminophen) was given to each patient who was instructed to take it if necessary. |
|
| Group 2- Received Dexamethasone (N=44) | Active Comparator | This group receives 1 hour before surgery 4 mg dexamethasone (and another 4 mg 6 hours after the first dose) Acetaminophen 1000 mg: A Rescue medication (1000 mg acetaminophen) was given to each patient who was instructed to take it if necessary. |
|
| Group 3 - Received Placebo (N=44) | Placebo Comparator | This group receives 1 hour before surgery placebo. Acetaminophen 1000 mg: A Rescue medication (1000 mg acetaminophen) was given to each patient who was instructed to take it if necessary. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ibuprofen 600 mg | Drug | This group receives 1 hour before surgery 600 mg ibuprofen (and another 600 mg dose 6 hours after the first dose); |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Visual Analog Scale (VAS) Was Used to Measures Levels of Pain. | The Visual Analog Scale (VAS) is a 10-cm line with two extremes at either end: "no pain" (0) and "pain that could not be more severe" (10). Patients were asked to mark a point on the line that best represented their perceived level of pain. The marked position on the line was then measured in centimeters to provide a score between 0 and 10.
| 8 hours-time |
| Measure | Description | Time Frame |
|---|---|---|
| the 101-point Numerical Rate Scale (NRS-101) Was Used to Measures Levels of Pain. | The Numerical Rating Scale (NRS-101) is a scale ranging from 0 to 100, where 0 represents "no pain" and 10(0) represents either "the worst possible pain" or "the most intense pain imaginable".
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maha Bahammam, Sc, CAGS, EdM, DABP | King Abdulaziz University | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27562219 | Derived | Bahammam MA, Kayal RA, Alasmari DS, Attia MS, Bahammam LA, Hassan MH, Alzoman HA, Almas K, Steffens JP. Comparison Between Dexamethasone and Ibuprofen for Postoperative Pain Prevention and Control After Surgical Implant Placement: A Double-Masked, Parallel-Group, Placebo-Controlled Randomized Clinical Trial. J Periodontol. 2017 Jan;88(1):69-77. doi: 10.1902/jop.2016.160353. Epub 2016 Aug 26. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1- Received Ibuprofen (N=44) | Ibuprofen 600 mg: This group receives 1 hour before surgery 600 mg ibuprofen (and another 600 mg dose 6 hours after the first dose); Acetaminophen 1000 mg: A Rescue medication (1000 mg acetaminophen) was given to each patient who was instructed to take it if necessary. |
| FG001 | Group 2- Received Dexamethasone (N=44) | Dexamethasone 4 mg: This group receives 1 hour before surgery 4 mg dexamethasone (and another 4 mg 6 hours after the first dose) Acetaminophen 1000 mg: A Rescue medication (1000 mg acetaminophen) was given to each patient who was instructed to take it if necessary. |
| FG002 | Group 3 - Received Placebo (N=44) | Placebo: This group receives 1 hour before surgery placebo. Acetaminophen 1000 mg: A Rescue medication (1000 mg acetaminophen) was given to each patient who was instructed to take it if necessary. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1- Received Ibuprofen (N=39) | Ibuprofen 600 mg: This group receives 1 hour before surgery 600 mg ibuprofen (and another 600 mg dose 6 hours after the first dose); Acetaminophen 1000 mg: A Rescue medication (1000 mg acetaminophen) was given to each patient who was instructed to take it if necessary. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Visual Analog Scale (VAS) Was Used to Measures Levels of Pain. | The Visual Analog Scale (VAS) is a 10-cm line with two extremes at either end: "no pain" (0) and "pain that could not be more severe" (10). Patients were asked to mark a point on the line that best represented their perceived level of pain. The marked position on the line was then measured in centimeters to provide a score between 0 and 10.
| Posted | Mean | 95% Confidence Interval | score on a scale | 8 hours-time |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group 1- Received Ibuprofen (N=39) | Ibuprofen 600 mg: This group receives 1 hour before surgery 600 mg ibuprofen (and another 600 mg dose 6 hours after the first dose); Acetaminophen 1000 mg: A Rescue medication (1000 mg acetaminophen) was given to each patient who was instructed to take it if necessary |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Maha A Bahammam | King Abdulaziz University | 00966126400000 | mbahammam@kau.edu.sa |
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| ID | Term |
|---|---|
| D007052 | Ibuprofen |
| D003907 | Dexamethasone |
| D000082 | Acetaminophen |
| ID | Term |
|---|---|
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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|
| Dexamethasone 4 mg | Drug | This group receives 1 hour before surgery 4 mg dexamethasone (and another 4 mg 6 hours after the first dose) |
|
|
| Placebo | Drug | This group receives 1 hour before surgery placebo. |
|
|
| Acetaminophen 1000 mg | Drug | A Rescue medication (1000 mg acetaminophen) was given to each patient who was instructed to take it if necessary. |
|
|
| 8 hours-time |
| The 4-point Verbal Rating Scale (VRS-4) Was Used to Measures Levels of Discomfort. | The 4-point Verbal Rating Scale (VRS-4) is a verbal scale used to assess the severity of a given condition, such as pain. Patients rate their experience by selecting one of four verbal descriptors that best represents their perceived intensity, ranging from "no pain" to "severe pain."
| 8 hours-time |
| Group 2- Received Dexamethasone (N=43) |
Dexamethasone 4 mg: This group receives 1 hour before surgery 4 mg dexamethasone (and another 4 mg 6 hours after the first dose) Acetaminophen 1000 mg: A Rescue medication (1000 mg acetaminophen) was given to each patient who was instructed to take it if necessary. |
| BG002 | Group 3 - Received Placebo (N=35) | Placebo: This group receives 1 hour before surgery placebo. Acetaminophen 1000 mg: A Rescue medication (1000 mg acetaminophen) was given to each patient who was instructed to take it if necessary. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Inclusion criteria
| Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Group 2- Received Dexamethasone (N=43) | Dexamethasone 4 mg: This group receives 1 hour before surgery 4 mg dexamethasone (and another 4 mg 6 hours after the first dose) Acetaminophen 1000 mg: A Rescue medication (1000 mg acetaminophen) was given to each patient who was instructed to take it if necessary. |
| OG002 | Group 3 - Received Placebo (N=35) | Placebo: This group receives 1 hour before surgery placebo. Acetaminophen 1000 mg: A Rescue medication (1000 mg acetaminophen) was given to each patient who was instructed to take it if necessary. |
|
|
| Secondary | the 101-point Numerical Rate Scale (NRS-101) Was Used to Measures Levels of Pain. | The Numerical Rating Scale (NRS-101) is a scale ranging from 0 to 100, where 0 represents "no pain" and 10(0) represents either "the worst possible pain" or "the most intense pain imaginable".
| Posted | Median | 95% Confidence Interval | score on a scale | 8 hours-time |
|
|
|
| Secondary | The 4-point Verbal Rating Scale (VRS-4) Was Used to Measures Levels of Discomfort. | The 4-point Verbal Rating Scale (VRS-4) is a verbal scale used to assess the severity of a given condition, such as pain. Patients rate their experience by selecting one of four verbal descriptors that best represents their perceived intensity, ranging from "no pain" to "severe pain."
| Posted | Median | 95% Confidence Interval | score on a scale | 8 hours-time |
|
|
|
|
| 0 |
| 39 |
| 0 |
| 39 |
| 0 |
| 39 |
| EG001 | Group 2- Received Dexamethasone (N=43) | Dexamethasone 4 mg: This group receives 1 hour before surgery 4 mg dexamethasone (and another 4 mg 6 hours after the first dose) Acetaminophen 1000 mg: A Rescue medication (1000 mg acetaminophen) was given to each patient who was instructed to take it if necessary. | 0 | 43 | 0 | 43 | 0 | 43 |
| EG002 | Group 3 - Received Placebo (N=35) | Placebo: This group receives 1 hour before surgery placebo. Acetaminophen 1000 mg: A Rescue medication (1000 mg acetaminophen) was given to each patient who was instructed to take it if necessary. | 0 | 35 | 0 | 35 | 0 | 35 |
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| D011246 |
| Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| The Kruskal-Wallis test is an omnibus test comparing all three independent groups on the pain/discomfort outcome. | Kruskal-Wallis | <0.0001 | Kruskal-Wallis test, a non-parametric omnibus test, was used followed by Dunn's multiple comparison test for pairwise group analysis. A priori threshold for statistical significance was set at p < 0.05 with no adjustments for multiple comparisons. | Other | Kruskal-Wallis |