Pain MeasurementPhase 4CBDIPPCFSIPNCT02763059
Comparison Between Dexamethasone and Ibuprofen on Pain Prevention and Control Following Surgical Implant Placement
A Phase 4 study testing Ibuprofen 600 mg, Dexamethasone 4 mg and Acetaminophen 1000 mg in people with Pain Measurement, run by King Abdulaziz University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain Measurement
- What is being tested?
- Ibuprofen 600 mg, Dexamethasone 4 mg and Acetaminophen 1000 mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 132 participants
- Where
- No sites listed yet
- Study dates
- Sep 2013to Feb 2016
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Informed consent for the described procedure
- Surgical placement of a single endosteal implant
- Age of at least 18 years
Who cannot join
- The need for bone grafting or sinus lift for implant placement
- Pregnant and lactating women
- Metabolic disorders
- Immunocompromised status
- Hemophilia or bleeding disorders
- Drug or alcohol abuse
Show all 10Show fewer
- Treatment with steroids in the previous 6 months
- History of radiation therapy in the head and neck
- Psychiatric disorders
- Inability to understand the procedure described in the questionnaire
About this study
Official title: Comparison Between Dexamethasone and Ibuprofen on Postoperative Pain Prevention and Control Following Surgical Implant Placement: a Double-Blind, Parallel-Group, Placebo-Controlled Randomized Clinical Trial
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:
Read more
- 600 mg ibuprofen (and another 600 mg dose 6 hours after the first dose);
- 4 mg dexamethasone (and another 4 mg 6 hours after the first dose) or
- placebo.
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.
Read the detailed description
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.
- Conditions
- Pain Measurement
- Being tested
- Ibuprofen 600 mg, Dexamethasone 4 mg, Placebo, Acetaminophen 1000 mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ibuprofen 600 mgDrug
Also called 600 mg ibuprofen (and another 600 mg dose 6 hours after the first dose).
This group receives 1 hour before surgery 600 mg ibuprofen (and another 600 mg dose 6 hours after the first dose);
Dexamethasone 4 mgDrug
Also called 4 mg dexamethasone (and another 4 mg 6 hours after the first dose)
This group receives 1 hour before surgery 4 mg dexamethasone (and another 4 mg 6 hours after the first dose)
PlaceboDrug
Also called Acetaminophen 1000 mg
This group receives 1 hour before surgery placebo.
Acetaminophen 1000 mgDrug
Also called A Rescue medication (1000 mg acetaminophen) was given to each patient who was instructed to take it if necessary.
A Rescue medication (1000 mg acetaminophen) was given to each patient who was instructed to take it if necessary.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Ibuprofen 600 mg; Drug: Acetaminophen 1000 mg |
| 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. Receives: Drug: Dexamethasone 4 mg; Drug: Acetaminophen 1000 mg |
| 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. Receives: Drug: Placebo; Drug: Acetaminophen 1000 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- Minimum Score: 0 (No pain)
- Maximum Score: 10 (Pain that could not be more severe)
- Interpretation: Lower scores indicate better outcomes, representing lower levels of perceived pain. Higher scores indicate worse outcomes, representing greater levels of pain.
- Unit of Measure: Scores on a scale (0-10)
Measured: 8 hours-time
Secondary outcomes (2)
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".
- Minimum Score: 0 (No pain)
- Maximum Score: 100 (Worst possible pain)
- Interpretation: Lower scores indicate better outcomes, representing lower levels of perceived pain. Higher scores indicate worse outcomes, representing higher levels of perceived pain.
- Unit of Measure: Scores on a scale (0-100)
Measured: 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."
- Minimum Score: 0 (No pain)
- Maximum Score: 3 (Severe pain)
- Interpretation: Lower scores indicate better outcomes, representing lower levels of perceived severity. Higher scores indicate worse outcomes, representing greater levels of severity.
- Unit of Measure: Scores on a scale (0-3)
Measured: 8 hours-time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2016 (estimated)
- Study startSep 2013
- Primary completionMay 2015
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain MeasurementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Abdulaziz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maha A. Bahammam, King Abdulaziz University
- Investigators
- Maha Bahammam, DABP, Study director, King Abdulaziz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02763059
- Sponsor's protocol ID
- 1434/254/287
- Acronym
- CBDIPPCFSIP
- Status last verified
- Aug 2026
- First submitted
- 1 May 2016
- Last updated
- 21 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 27562219
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Dexamethasone and Ibuprofen on Postoperative Pain Prevention and Control Following Surgical Implant Placement: a Double-Blind, Parallel-Group, Placebo-Controlled Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02763059
- Acronym / sponsor ID
- CBDIPPCFSIP / 1434/254/287
- Conditions
- Pain Measurement
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- King Abdulaziz UniversityUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- May 2015 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 5 May 2016 (estimated)
- Results
- Posted 29 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 600 mg ibuprofen (and another 600 mg dose 6 hours after the first dose);
- 4 mg dexamethasone (and another 4 mg 6 hours after the first dose) or
- placebo.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1- Received Ibuprofen (N=44) | Active comparator | Drug: Ibuprofen 600 mg, Drug: Acetaminophen 1000 mgThis 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 | Drug: Dexamethasone 4 mg, Drug: Acetaminophen 1000 mgThis 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 | Drug: Placebo, Drug: Acetaminophen 1000 mgThis 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Informed consent for the described procedure
- Surgical placement of a single endosteal implant
- Age of at least 18 years
Key exclusion criteria (10 listed)
- The need for bone grafting or sinus lift for implant placement
- Pregnant and lactating women
- Metabolic disorders
- Immunocompromised status
- Hemophilia or bleeding disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ibuprofen 600 mgAlso: 600 mg ibuprofen (and another 600 mg dose 6 hours after the first dose).This group receives 1 hour before surgery 600 mg ibuprofen (and another 600 mg dose 6 hours after the first dose); | Drug | Group 1- Received Ibuprofen (N=44) |
| Dexamethasone 4 mgAlso: 4 mg dexamethasone (and another 4 mg 6 hours after the first dose)This group receives 1 hour before surgery 4 mg dexamethasone (and another 4 mg 6 hours after the first dose) | Drug | Group 2- Received Dexamethasone (N=44) |
| PlaceboAlso: Acetaminophen 1000 mgThis group receives 1 hour before surgery placebo. | Drug | Group 3 - Received Placebo (N=44) |
| Acetaminophen 1000 mgAlso: A Rescue medication (1000 mg acetaminophen) was given to each patient who was instructed to take it if necessary.A Rescue medication (1000 mg acetaminophen) was given to each patient who was instructed to take it if necessary. | Drug | Group 1- Received Ibuprofen (N=44), Group 2- Received Dexamethasone (N=44), Group 3 - Received Placebo (N=44) |
Primary outcome
The Visual Analog Scale (VAS) Was Used to Measures Levels of Pain.
Time frame: 8 hours-time
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. * Minimum Score: 0 (No pain) * Maximum Score: 10 (Pain that could not be more severe) * Interpretation: Lower scores indicate better outcomes, representing lower levels of perceived pain. Higher scores indicate worse outcomes, representing greater levels of pain. * Unit of Measure: Scores on a scale (0-10)
2 secondary outcomes
the 101-point Numerical Rate Scale (NRS-101) Was Used to Measures Levels of Pain.
Time frame: 8 hours-time
The 4-point Verbal Rating Scale (VRS-4) Was Used to Measures Levels of Discomfort.
Time frame: 8 hours-time
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27562219Bahammam 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maha Bahammam, DABP study director
King Abdulaziz University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ibuprofen 600 mg, Dexamethasone 4 mg and Acetaminophen 1000 mg in people with Pain Measurement, run by King Abdulaziz University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Visual Analog Scale (VAS) Was Used to Measures Levels of Pain. (time frame: 8 hours-time). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02763059, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.