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

NCT03789058 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2021-08-30

No results posted yet for this study

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.

Conditions

  • Operation Site Inflammation
  • Pain, Postoperative
  • Teeth, Impacted

Interventions

DRUG

Ibuprofen 400 mg

Surgical removal of wisdom teethb with different regimen of Ibuprofen frequency ; three times versus two times .

Sponsors & Collaborators

  • McGill University

    collaborator OTHER

  • InterPharma One LLC

    collaborator NETWORK

  • Jordan University of Science and Technology

    lead OTHER

Principal Investigators

  • Zaid Z Tamimi, HSD · JUST

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-04-19
Primary Completion
2021-12-31
Completion
2022-12-31

Countries

  • Jordan

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03789058 on ClinicalTrials.gov