Ignite Creation Date:
2025-12-24 @ 3:06 PM
Ignite Modification Date:
2026-01-01 @ 8:30 AM
Study NCT ID:
NCT02763059
Status:
COMPLETED
Last Update Posted:
2025-11-13
First Post:
2016-05-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparison Between Dexamethasone and Ibuprofen on Pain Prevention and Control Following Surgical Implant Placement
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D007052', 'term': 'Ibuprofen'}, {'id': 'D003907', 'term': 'Dexamethasone'}, {'id': 'D000082', 'term': 'Acetaminophen'}], 'ancestors': [{'id': 'D010666', 'term': 'Phenylpropionates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}, {'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mbahammam@kau.edu.sa', 'phone': '00966126400000', 'title': 'Prof. Maha A Bahammam', 'organization': 'King Abdulaziz University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Group 1- Received Ibuprofen (N=39)', 'description': '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', 'otherNumAtRisk': 39, 'deathsNumAtRisk': 39, 'otherNumAffected': 0, 'seriousNumAtRisk': 39, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Group 2- Received Dexamethasone (N=43)', 'description': '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.', 'otherNumAtRisk': 43, 'deathsNumAtRisk': 43, 'otherNumAffected': 0, 'seriousNumAtRisk': 43, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Group 3 - Received Placebo (N=35)', 'description': '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.', 'otherNumAtRisk': 35, 'deathsNumAtRisk': 35, 'otherNumAffected': 0, 'seriousNumAtRisk': 35, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Visual Analog Scale (VAS) Was Used to Measures Levels of Pain.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1- Received Ibuprofen (N=39)', 'description': 'Ibuprofen 600 mg: This group receives 1 hour before surgery 600 mg ibuprofen (and another 600 mg dose 6 hours after the first dose);\n\nAcetaminophen 1000 mg: A Rescue medication (1000 mg acetaminophen) was given to each patient who was instructed to take it if necessary.'}, {'id': 'OG001', 'title': 'Group 2- Received Dexamethasone (N=43)', 'description': 'Dexamethasone 4 mg: This group receives 1 hour before surgery 4 mg dexamethasone (and another 4 mg 6 hours after the first dose)\n\nAcetaminophen 1000 mg: A Rescue medication (1000 mg acetaminophen) was given to each patient who was instructed to take it if necessary.'}, {'id': 'OG002', 'title': 'Group 3 - Received Placebo (N=35)', 'description': 'Placebo: This group receives 1 hour before surgery placebo.\n\nAcetaminophen 1000 mg: A Rescue medication (1000 mg acetaminophen) was given to each patient who was instructed to take it if necessary.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '1.08', 'upperLimit': '4.40'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '1.57', 'upperLimit': '3.00'}, {'value': '5.0', 'groupId': 'OG002', 'lowerLimit': '3.96', 'upperLimit': '7.01'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 hours-time', 'description': '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.\n\n* Minimum Score: 0 (No pain)\n* Maximum Score: 10 (Pain that could not be more severe)\n* Interpretation: Lower scores indicate better outcomes, representing lower levels of perceived pain. Higher scores indicate worse outcomes, representing greater levels of pain.\n* Unit of Measure: Scores on a scale (0-10)', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'the 101-point Numerical Rate Scale (NRS-101) Was Used to Measures Levels of Pain.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1- Received Ibuprofen (N=39)', 'description': 'Ibuprofen 600 mg: This group receives 1 hour before surgery 600 mg ibuprofen (and another 600 mg dose 6 hours after the first dose);\n\nAcetaminophen 1000 mg: A Rescue medication (1000 mg acetaminophen) was given to each patient who was instructed to take it if necessary.'}, {'id': 'OG001', 'title': 'Group 2- Received Dexamethasone (N=43)', 'description': 'Dexamethasone 4 mg: This group receives 1 hour before surgery 4 mg dexamethasone (and another 4 mg 6 hours after the first dose)\n\nAcetaminophen 1000 mg: A Rescue medication (1000 mg acetaminophen) was given to each patient who was instructed to take it if necessary.'}, {'id': 'OG002', 'title': 'Group 3 - Received Placebo (N=35)', 'description': 'Placebo: This group receives 1 hour before surgery placebo.\n\nAcetaminophen 1000 mg: A Rescue medication (1000 mg acetaminophen) was given to each patient who was instructed to take it if necessary.'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '4.74', 'upperLimit': '9.19'}, {'value': '6', 'groupId': 'OG001', 'lowerLimit': '5.66', 'upperLimit': '8.37'}, {'value': '39', 'groupId': 'OG002', 'lowerLimit': '33.65', 'upperLimit': '45.06'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '8 hours-time', 'description': '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".\n\n* Minimum Score: 0 (No pain)\n* Maximum Score: 100 (Worst possible pain)\n* Interpretation: Lower scores indicate better outcomes, representing lower levels of perceived pain. Higher scores indicate worse outcomes, representing higher levels of perceived pain.\n* Unit of Measure: Scores on a scale (0-100)', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'The 4-point Verbal Rating Scale (VRS-4) Was Used to Measures Levels of Discomfort.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1- Received Ibuprofen (N=39)', 'description': 'Ibuprofen 600 mg: This group receives 1 hour before surgery 600 mg ibuprofen (and another 600 mg dose 6 hours after the first dose);\n\nAcetaminophen 1000 mg: A Rescue medication (1000 mg acetaminophen) was given to each patient who was instructed to take it if necessary.'}, {'id': 'OG001', 'title': 'Group 2- Received Dexamethasone (N=43)', 'description': 'Dexamethasone 4 mg: This group receives 1 hour before surgery 4 mg dexamethasone (and another 4 mg 6 hours after the first dose)\n\nAcetaminophen 1000 mg: A Rescue medication (1000 mg acetaminophen) was given to each patient who was instructed to take it if necessary.'}, {'id': 'OG002', 'title': 'Group 3 - Received Placebo (N=35)', 'description': 'Placebo: This group receives 1 hour before surgery placebo.\n\nAcetaminophen 1000 mg: A Rescue medication (1000 mg acetaminophen) was given to each patient who was instructed to take it if necessary.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '1'}, {'value': '1', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '1'}, {'value': '2', 'groupId': 'OG002', 'lowerLimit': '1', 'upperLimit': '3'}]}]}], 'analyses': [{'pValue': '0.027', 'groupIds': ['OG000', 'OG001', 'OG002'], 'pValueComment': "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.", 'groupDescription': 'The Kruskal-Wallis test is an omnibus test comparing all three independent groups.', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Kruskal-Wallis'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001', 'OG002'], 'pValueComment': "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.", 'groupDescription': 'The Kruskal-Wallis test is an omnibus test comparing all three independent groups on the pain/discomfort outcome.', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Kruskal-Wallis'}], 'paramType': 'MEDIAN', 'timeFrame': '8 hours-time', 'description': '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."\n\n* Minimum Score: 0 (No pain)\n* Maximum Score: 3 (Severe pain)\n* Interpretation: Lower scores indicate better outcomes, representing lower levels of perceived severity. Higher scores indicate worse outcomes, representing greater levels of severity.\n* Unit of Measure: Scores on a scale (0-3)', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group 1- Received Ibuprofen (N=44)', 'description': 'Ibuprofen 600 mg: This group receives 1 hour before surgery 600 mg ibuprofen (and another 600 mg dose 6 hours after the first dose);\n\nAcetaminophen 1000 mg: A Rescue medication (1000 mg acetaminophen) was given to each patient who was instructed to take it if necessary.'}, {'id': 'FG001', 'title': 'Group 2- Received Dexamethasone (N=44)', 'description': 'Dexamethasone 4 mg: This group receives 1 hour before surgery 4 mg dexamethasone (and another 4 mg 6 hours after the first dose)\n\nAcetaminophen 1000 mg: A Rescue medication (1000 mg acetaminophen) was given to each patient who was instructed to take it if necessary.'}, {'id': 'FG002', 'title': 'Group 3 - Received Placebo (N=44)', 'description': 'Placebo: This group receives 1 hour before surgery placebo.\n\nAcetaminophen 1000 mg: A Rescue medication (1000 mg acetaminophen) was given to each patient who was instructed to take it if necessary.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}, {'groupId': 'FG001', 'numSubjects': '44'}, {'groupId': 'FG002', 'numSubjects': '44'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}, {'groupId': 'FG001', 'numSubjects': '43'}, {'groupId': 'FG002', 'numSubjects': '35'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '9'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}, {'value': '117', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Group 1- Received Ibuprofen (N=39)', 'description': 'Ibuprofen 600 mg: This group receives 1 hour before surgery 600 mg ibuprofen (and another 600 mg dose 6 hours after the first dose);\n\nAcetaminophen 1000 mg: A Rescue medication (1000 mg acetaminophen) was given to each patient who was instructed to take it if necessary.'}, {'id': 'BG001', 'title': 'Group 2- Received Dexamethasone (N=43)', 'description': 'Dexamethasone 4 mg: This group receives 1 hour before surgery 4 mg dexamethasone (and another 4 mg 6 hours after the first dose)\n\nAcetaminophen 1000 mg: A Rescue medication (1000 mg acetaminophen) was given to each patient who was instructed to take it if necessary.'}, {'id': 'BG002', 'title': 'Group 3 - Received Placebo (N=35)', 'description': 'Placebo: This group receives 1 hour before surgery placebo.\n\nAcetaminophen 1000 mg: A Rescue medication (1000 mg acetaminophen) was given to each patient who was instructed to take it if necessary.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}, {'value': '117', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '33.0', 'groupId': 'BG000', 'lowerLimit': '32.0', 'upperLimit': '37.0'}, {'value': '35.0', 'groupId': 'BG001', 'lowerLimit': '33.0', 'upperLimit': '44.0'}, {'value': '41.0', 'groupId': 'BG002', 'lowerLimit': '34.0', 'upperLimit': '50.0'}, {'value': '35', 'groupId': 'BG003', 'lowerLimit': '32.0', 'upperLimit': '50.0'}]}]}], 'paramType': 'MEAN', 'description': 'Inclusion criteria\n\n1. written informed consent for the described procedure;\n2. surgical placement of a single endosteal implant; and\n3. age \\>18 years.', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '54', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '63', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Saudi Arabia', 'categories': [{'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}, {'value': '117', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 132}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-29', 'studyFirstSubmitDate': '2016-05-01', 'resultsFirstSubmitDate': '2024-03-05', 'studyFirstSubmitQcDate': '2016-05-04', 'lastUpdatePostDateStruct': {'date': '2025-11-13', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-10-18', 'studyFirstPostDateStruct': {'date': '2016-05-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2025-10-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Visual Analog Scale (VAS) Was Used to Measures Levels of Pain.', 'timeFrame': '8 hours-time', 'description': '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.\n\n* Minimum Score: 0 (No pain)\n* Maximum Score: 10 (Pain that could not be more severe)\n* Interpretation: Lower scores indicate better outcomes, representing lower levels of perceived pain. Higher scores indicate worse outcomes, representing greater levels of pain.\n* Unit of Measure: Scores on a scale (0-10)'}], 'secondaryOutcomes': [{'measure': 'the 101-point Numerical Rate Scale (NRS-101) Was Used to Measures Levels of Pain.', 'timeFrame': '8 hours-time', 'description': '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".\n\n* Minimum Score: 0 (No pain)\n* Maximum Score: 100 (Worst possible pain)\n* Interpretation: Lower scores indicate better outcomes, representing lower levels of perceived pain. Higher scores indicate worse outcomes, representing higher levels of perceived pain.\n* Unit of Measure: Scores on a scale (0-100)'}, {'measure': 'The 4-point Verbal Rating Scale (VRS-4) Was Used to Measures Levels of Discomfort.', 'timeFrame': '8 hours-time', 'description': '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."\n\n* Minimum Score: 0 (No pain)\n* Maximum Score: 3 (Severe pain)\n* Interpretation: Lower scores indicate better outcomes, representing lower levels of perceived severity. Higher scores indicate worse outcomes, representing greater levels of severity.\n* Unit of Measure: Scores on a scale (0-3)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Pain Measurement']}, 'referencesModule': {'references': [{'pmid': '27562219', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nMethods: 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:\n\n1. 600 mg ibuprofen (and another 600 mg dose 6 hours after the first dose);\n2. 4 mg dexamethasone (and another 4 mg 6 hours after the first dose) or\n3. placebo.\n\nRescue 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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Informed consent for the described procedure\n* Surgical placement of a single endosteal implant\n* Age of at least 18 years\n\nExclusion Criteria:\n\n* The need for bone grafting or sinus lift for implant placement\n* Pregnant and lactating women\n* Metabolic disorders\n* Immunocompromised status\n* Hemophilia or bleeding disorders\n* Drug or alcohol abuse\n* Treatment with steroids in the previous 6 months\n* History of radiation therapy in the head and neck\n* Psychiatric disorders\n* Inability to understand the procedure described in the questionnaire'}, 'identificationModule': {'nctId': 'NCT02763059', 'acronym': 'CBDIPPCFSIP', 'briefTitle': 'Comparison Between Dexamethasone and Ibuprofen on Pain Prevention and Control Following Surgical Implant Placement', 'organization': {'class': 'OTHER', 'fullName': 'King Abdulaziz University'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '1434/254/287'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group 1- Received Ibuprofen (N=44)', 'description': 'This group receives 1 hour before surgery 600 mg ibuprofen (and another 600 mg dose 6 hours after the first dose).\n\nAcetaminophen 1000 mg: A Rescue medication (1000 mg acetaminophen) was given to each patient who was instructed to take it if necessary.', 'interventionNames': ['Drug: Ibuprofen 600 mg', 'Drug: Acetaminophen 1000 mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 2- Received Dexamethasone (N=44)', 'description': '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.', 'interventionNames': ['Drug: Dexamethasone 4 mg', 'Drug: Acetaminophen 1000 mg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Group 3 - Received Placebo (N=44)', 'description': '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.', 'interventionNames': ['Drug: Placebo', 'Drug: Acetaminophen 1000 mg']}], 'interventions': [{'name': 'Ibuprofen 600 mg', 'type': 'DRUG', 'otherNames': ['600 mg ibuprofen (and another 600 mg dose 6 hours after the first dose).'], 'description': 'This group receives 1 hour before surgery 600 mg ibuprofen (and another 600 mg dose 6 hours after the first dose);', 'armGroupLabels': ['Group 1- Received Ibuprofen (N=44)']}, {'name': 'Dexamethasone 4 mg', 'type': 'DRUG', 'otherNames': ['4 mg dexamethasone (and another 4 mg 6 hours after the first dose)'], 'description': 'This group receives 1 hour before surgery 4 mg dexamethasone (and another 4 mg 6 hours after the first dose)', 'armGroupLabels': ['Group 2- Received Dexamethasone (N=44)']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Acetaminophen 1000 mg'], 'description': 'This group receives 1 hour before surgery placebo.', 'armGroupLabels': ['Group 3 - Received Placebo (N=44)']}, {'name': 'Acetaminophen 1000 mg', 'type': 'DRUG', 'otherNames': ['A Rescue medication (1000 mg acetaminophen) was given to each patient who was instructed to take it if necessary.'], 'description': 'A Rescue medication (1000 mg acetaminophen) was given to each patient who was instructed to take it if necessary.', 'armGroupLabels': ['Group 1- Received Ibuprofen (N=44)', 'Group 2- Received Dexamethasone (N=44)', 'Group 3 - Received Placebo (N=44)']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Maha Bahammam, Sc, CAGS, EdM, DABP', 'role': 'STUDY_DIRECTOR', 'affiliation': 'King Abdulaziz University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'King Abdulaziz University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor and Consultant of Periodontology', 'investigatorFullName': 'Maha A. Bahammam', 'investigatorAffiliation': 'King Abdulaziz University'}}}}