Efficacy of Ibuprofen Chronotherapy in Healing After Surgical Extraction of the Mandibular Third Molar
Status:
Recruiting
Trial end date:
2022-12-01
Target enrollment:
Participant gender:
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.