Accepted for/Published in: JMIR Research Protocols
Date Submitted: Dec 10, 2021
Open Peer Review Period: Dec 8, 2021 - Dec 21, 2021
Date Accepted: Apr 22, 2022
Date Submitted to PubMed: Apr 23, 2022
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Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Efficacy of ibuprofen gargle for postoperative pain after mandibular third molar extraction: a phase II, placebo-controlled, double-blind, randomized crossover trial
ABSTRACT
Background:
Extraction of mandibular third molars is one of the most commonly performed oral surgical procedures, and non-steroidal anti-inflammatory drugs (NSAIDs) are widely used for pain management. Oral administration of NSAIDs can produce various adverse events such as gastrointestinal disorders, renal and hepatic dysfunction, and platelet dysfunction. Topical use of analgesics has been proposed as an alternative to oral and injectable medications to safely improve postoperative pain relief. We will conduct a single-center, placebo-controlled, double-blind, randomized crossover trial to assess the pain-relieving effect of an ibuprofen-containing gargle in patients undergoing extraction of mandibular third molars in comparison with a placebo gargle.
Objective:
This will be the first clinical study to evaluate the efficacy of ibuprofen gargle for relieving postoperative pain after extraction of mandibular third molars.
Methods:
This study will be performed at Kobe University Hospital. Participants (n = 40) will be randomized equally to one of two groups. The IP group will receive ibuprofen gargle on postoperative day (POD) 1 and placebo gargle on POD 2. The PI group will receive placebo gargle on POD 1 and ibuprofen gargle on POD 2. Both groups will receive ibuprofen gargle on PODs 3 to 5 at least once daily. The primary objective is to estimate the within-subject difference in a visual analogue scale (VAS) before and 5 minutes after use of ibuprofen or placebo gargle on PODs 1 and 2. The secondary objectives are to estimate the within-subject difference in ΔVAS before and 15 minutes after use of ibuprofen or placebo gargle on PODs 1 and 2, the ΔVAS before and after 5 or 15 minutes of use of ibuprofen gargle on PODs 3 to 5, the overall effectiveness (self-completion, five scales) on PODs 1 to 5, the daily frequency of use (ibuprofen or placebo gargle and analgesics) on PODs 1 to 7, and the occurrence of adverse events.
Results:
The Kobe university Certified Review Board approved the study. The intervention was implemented in May 2021.
Conclusions:
This trial will provide exploratory evidence of the efficacy and safety of ibuprofen gargle for pain reduction after mandibular third molar extraction. Clinical Trial: Japan Registry of Clinical Trials (jRCT) identifier: jRCTs051210022. Registered on 10 May 2021.
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