Efficacy of Ibuprofen Chronotherapy in Healing After Surgical Extraction of the Mandibular Third … (NCT03789058) | Clinical Trial Compass
UnknownPhase 2/3
Efficacy of Ibuprofen Chronotherapy in Healing After Surgical Extraction of the Mandibular Third Molar
Jordan70 participantsStarted 2018-04-19
Plain-language 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.
Who can participate
Age range
18 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pain Measurement
Timeframe: four days measurement of VAS
Trial details
NCT IDNCT03789058
SponsorJordan University of Science and Technology