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Comparison Between Dexamethasone and Ibuprofen on Pain Prevention and Control Following Surgical Implant Placement (CBDIPPCFSIP)

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ClinicalTrials.gov Identifier: NCT02763059
Recruitment Status : Completed
First Posted : May 5, 2016
Last Update Posted : May 5, 2016
Sponsor:
Information provided by (Responsible Party):
Maha A. Bahammam, King Abdulaziz University

Brief 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.

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:

  1. 600 mg ibuprofen (and another 600 mg dose 6 hours after the first dose);
  2. 4 mg dexamethasone (and another 4 mg 6 hours after the first dose) or
  3. 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.


Condition or disease Intervention/treatment Phase
Pain Measurement Drug: Ibuprofen 600 mg Drug: Dexamethasone 4 mg Drug: Placebo Drug: Acetaminophen 1000 mg Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 132 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
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
Study Start Date : September 2013
Actual Primary Completion Date : May 2015
Actual Study Completion Date : February 2016


Arm Intervention/treatment
Active Comparator: Group 1- Received Ibuprofen (N=44) Drug: Ibuprofen 600 mg
This group receives 1 hour before surgery 600 mg ibuprofen (and another 600 mg dose 6 hours after the first dose);

Drug: Acetaminophen 1000 mg
A Rescue medication (1000 mg acetaminophen) was given to each patient who was instructed to take it if necessary.

Active Comparator: Group 2- Received Dexamethasone (N=44) Drug: Dexamethasone 4 mg
This group receives 1 hour before surgery 4 mg dexamethasone (and another 4 mg 6 hours after the first dose)

Drug: Acetaminophen 1000 mg
A Rescue medication (1000 mg acetaminophen) was given to each patient who was instructed to take it if necessary.

Placebo Comparator: Group 3 - Received Placebo (N=44) Drug: Placebo
This group receives 1 hour before surgery placebo.

Drug: Acetaminophen 1000 mg
A Rescue medication (1000 mg acetaminophen) was given to each patient who was instructed to take it if necessary.




Primary Outcome Measures :
  1. The visual analog scale (VAS) was used to measures levels of pain. [ Time Frame: 8 hours-time ]
    a visual analog scale (VAS) consisting of a 10-cm line with two extremes at either end; "no pain" and "pain that could not be more severe". Patients were asked to mark a point on the line that represented their level of perceived pain.


Secondary Outcome Measures :
  1. the 101-point numerical rate scale (NRS-101) was used to measures levels of pain. [ Time Frame: 8 hours-time ]
    the patients were asked to rate their pain intensity on a numeric scale ranging from 0 to 100.

  2. The 4-point verbal rating scale (VRS-4) was used to measures levels of discomfort. [ Time Frame: 8 hours-time ]
    the patient specifies one of four options: no discomfort, some discomfort, considerable discomfort, or discomfort that could not be more severe.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Informed consent for the described procedure
  • Surgical placement of a single endosteal implant
  • Age of at least 18 years

Exclusion Criteria:

  • 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
  • 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Maha A. Bahammam, Associate Professor and Consultant of Periodontology, King Abdulaziz University
ClinicalTrials.gov Identifier: NCT02763059    
Other Study ID Numbers: 1434/254/287
First Posted: May 5, 2016    Key Record Dates
Last Update Posted: May 5, 2016
Last Verified: May 2016
Additional relevant MeSH terms:
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Acetaminophen
Dexamethasone
Dexamethasone acetate
Ibuprofen
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Antipyretics
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Cyclooxygenase Inhibitors