Diclofenac transbuccal mucoadhesive patch effective,safe for pain control after third molar surgery: Study

Swelling, pain, and trismus are the most common sequelae after surgical removal of mandibular third molars. They pose significant challenges for clinicians, prompting the exploration of efficacious management approaches. Therefore, Zenish Bhatti, AMC Dental College and Hospital, Khokhara, Ahmedabad, Gujarat, India, and colleagues aimed to assess the efficacy of transbuccal mucoadhesive patch of diclofenac sodium versus oral tablet in controlling sequelae after a third molar surgery.

For this purpose, they conducted a prospective split-mouth, single-blinded study in the Department of Oral and Maxillofacial Surgery at AMC Dental College and Hospital, Ahmedabad. The study sample comprised patients of either sex, aged 18-45 years, needing surgical removal of bilaterally symmetrical mandibular third molars under local anesthesia. It excluded patients who had consumed analgesics within 24 hours before the procedure.

The primary predictor variable was the route of non-steroidal anti-inflammatory drugs administration. The study group received transbuccal mucoadhesive patches of 20 mg diclofenac sodium; the control group received 50 mg oral tablets.

The primary outcome variable was postoperative pain measured with a visual analog scale (VAS); mouth opening, swelling, adverse events, and onset of analgesic effect were assessed as secondary outcome variables.

Two categories of covariates were considered. First, demographic – gender and age. Second, peri-operative – the pattern of impaction.

Paired sample t-test and independent sample t-test were used for intergroup comparison, and intragroup differences were assessed with One-way ANOVA and paired t-test.

The study led to the following findings:

· Out of 146 patients screened initially, the final study sample included 37 subjects with a mean age of 26.08±5.09 years (56.75% males).

· The study group exhibited significantly lower postoperative pain scores than the control group on day 0, 1st, 2nd, and 3rd days postoperatively.

· No statistically significant difference was observed in the reduction of facial swelling and improvement in mouth opening on the 1st, 2nd, and 3rd days, postoperatively between both the groups.

· The mean onset of analgesia was statistically significant in the study group (19.96 ± 5.40 minutes) compared to the control group (52.56 ± 6.33 minutes).

"Diclofenac transbuccal mucoadhesive patch is superior to oral diclofenac for management of postoperative sequelae after third molar surgery with effective pain control, fewer side effects, and quicker analgesia," the researchers concluded.

Reference:

DOI: https://doi.org/10.1016/j.joms.2024.03.019