Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

Efficacy of Ibuprofen Chronotherapy in Healing After Surgical Extraction of the Mandibular Third Molar

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03789058
Recruitment Status : Recruiting
First Posted : December 28, 2018
Last Update Posted : July 16, 2019
Sponsor:
Collaborators:
McGill University
InterPharma One LLC
Information provided by (Responsible Party):
Jordan University of Science and Technology

Brief Summary:

Clinical and preclinical studies have demonstrated encouraging results of non-steroidal anti-inflammatory drug (NSAID) chronotherapy in the management and treatment of inflammatory diseases such as rheumatoid arthritis. However, no previous clinical trials have addressed how the timing of NSAID administration within the day affects pain and healing outcomes after oral surgery that involves bone removal, such as surgical extraction of the third molars. Methods to address our aim, Single-center double-blind randomized controlled trial study design has been adopted. Patients who needed a lower third molar extraction and meet the eligibility criteria will be recruited. Participants will be randomized into two groups. Subjects in group one will be instructed to take an NSAID (ibuprofen 400 mg) at 7 AM and 12 PM combined with a placebo before bed between 8 and 10 PM for three days postoperatively. Subjects in group 2 will be instructed to take an NSAID (ibuprofen 400 mg) between 7 AM, 12 PM and between 8 and 10 PM for three days postoperatively. The patients' self-reported pain in the three days after surgery will be recorded as the primary outcome.

Additionally, healing indicators such as the maximum interincisal distance and measurements of facial swelling will be recorded preoperatively and four days postoperatively. Each participant's blood level of C-reactive protein will be recorded pre- and postoperatively as an inflammatory marker.

Discussion:

The study will estimate the effect of using NSAID only in the morning following surgical extraction of the third molar to decrease pain and improve postoperative healing and recovery in comparison to the routine use of NSAIDs three times per day.


Condition or disease Intervention/treatment Phase
Operation Site Inflammation Pain, Postoperative Teeth, Impacted Drug: Ibuprofen 400 mg Phase 2 Phase 3

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel Assignment a single-center double-blind randomized controlled trial
Masking: Double (Participant, Care Provider)
Masking Description: The treatment regimens were masked for both participants and care provider (Clinical investigator)
Primary Purpose: Supportive Care
Official Title: Efficacy of Non-Steroidal Anti-Inflammatory Drug (Ibuprofen) Chronotherapy in Healing After Surgical Extraction of the Mandibular Third Molar - A Randomized Clinical Trial Protocol
Actual Study Start Date : April 19, 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Control Group
Control group will have surgical intervention to remove wisdom tooth and receive conventional NSAID treatment three times per day
Drug: Ibuprofen 400 mg
Surgical removal of wisdom teethb with different regimen of Ibuprofen frequency ; three times versus two times .

Experimental: Treatment Group
The experimental group will have surgival intervention to remove wisdom tooth and receive NSAID treatment only two times per day: once after breakfast and once after lunch, but not at night.
Drug: Ibuprofen 400 mg
Surgical removal of wisdom teethb with different regimen of Ibuprofen frequency ; three times versus two times .




Primary Outcome Measures :
  1. Pain Measurement [ Time Frame: four days measurement of VAS ]
    Measuring of post operative pain severity according to Visual Analogue Scale healing indicators such as edema and mouth opening .


Secondary Outcome Measures :
  1. Inflammation Degree Measurement [ Time Frame: Pre-Op, 4th day after operation ]
    Inflammation Degree by measuring C-reactive Protein (CRP)

  2. Facial Swelling and mouth opening measuring [ Time Frame: pre-op, 4th day post op. ]
    Facial Swelling will be measured according to LASKIN method



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

(i) be aged between 18 and 35 years old

(ii) be healthy according to the American Society of Anesthesiologists (ASA) classification (subject should not have an active infection, trismus, hyperthermia, or swelling before surgery and must be able to maintain adequate oral hygiene)

(iii) have an adequate understanding of written and spoken English or Arabic to fill out a questionnaire,

(iv) be capable of signing an informed consent form

(vi) third molar surgical extraction, the indicated teeth should be lower third molars and partially or completely impacted

Exclusion Criteria:

(i) have a history of systemic diseases (e.g., diabetes mellitus, hypertension, gastric ulcer)

(ii) have a severe/serious illness that requires frequent hospitalization

(iii) are current smokers

(iv) are pregnant or breastfeeding

(v) are taking antinflammtory or analgesic drugs in the previous two weeks or are allergic to NSAIDs

(vi) have impaired cognitive or motor function

(vii) are unable to return for evaluations/study recalls.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03789058


Contacts
Layout table for location contacts
Contact: Zaid Z Tamimi, HSD 00962795036670 zztamimi@just.edu.jo
Contact: Ala M Abu Roqaa, M.SC. 00962795052394 director@interpharma-1.com

Locations
Layout table for location information
Jordan
Jordan University of Science and Technology Recruiting
Irbid, Jordan
Contact: Zaid Z Tamimi, HSD    00962795036670    zztamimi@just.edu.jo   
Contact: Ala M Abu Roqaa, M.SC.    00962795052394    director@interpharma-1.com   
Sponsors and Collaborators
Jordan University of Science and Technology
McGill University
InterPharma One LLC

Layout table for additonal information
Responsible Party: Jordan University of Science and Technology
ClinicalTrials.gov Identifier: NCT03789058    
Other Study ID Numbers: 20170307
First Posted: December 28, 2018    Key Record Dates
Last Update Posted: July 16, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: data will be provided upon request or required for publication .

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Tooth, Impacted
Inflammation
Pain, Postoperative
Pathologic Processes
Postoperative Complications
Pain
Neurologic Manifestations
Signs and Symptoms
Tooth Diseases
Stomatognathic Diseases
Ibuprofen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action