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

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Jordan University of Science and Technology
• Collaborators: InterPharma One LLC; McGill University
• Treatments: Anti-Inflammatory Agents, Non-Steroidal; Ibuprofen

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.