Is Diclofenac Transbuccal Mucoadhesive Patch Superior to Oral Diclofenac for the Management of Postoperative Sequelae After Third Molar Surgery?

BACKGROUND: Pain, swelling, and trismus are the most common sequalae following the surgical removal of mandibular third molars. They pose significant challenges for clinicians, prompting the exploration of efficacious management approaches.

PURPOSE: The purpose of this study was to assess the efficacy of transbuccal mucoadhesive patch of diclofenac sodium versus an oral tablet in controlling the aforesaid sequelae.

STUDY DESIGN, SETTING, SAMPLE: A prospective split-mouth, single-blinded study was conducted in the Department of Oral and Maxillofacial Surgery at AMC Dental College and Hospital, Ahmedabad. The study sample included patients of either sex, aged 18 to 45 years, requiring surgical removal of bilaterally symmetrical mandibular third molars under local anesthesia. Patients who had consumed analgesics within 24 hours prior to the procedure were excluded.

PREDICTOR VARIABLE: The primary predictor variable was the route of administration of nonsteroidal anti-inflammatory drug. The study group received transbuccal mucoadhesive patches containing 20 mg diclofenac sodium, whereas the control group received oral tablets of 50 mg.

MAIN OUTCOME VARIABLE: Postoperative pain, measured with visual analog scale, was the primary outcome variable, whereas swelling, mouth opening, onset of analgesic effect, and adverse events were assessed as secondary outcome variables.

COVARIATES: Two categories of covariates were considered. First, demographic: age and gender. Second, perioperative: pattern of impaction.

ANALYSES: Intergroup comparison was made using a paired sample t-test and an independent sample t-test, while intragroup differences were assessed with a one-way ANOVA and a paired t-test. P value ≤ .05 was considered statistically significant.

RESULTS: Out of 146 patients screened initially, the final study sample included 37 subjects with a mean age of 26.08 ± 5.09 years (21 (56.75%) males and 16 (43.25%) females). The study group exhibited a significantly lower postoperative pain score compared to the control group on days 0, 1, 2, and 3 postoperatively (P ≤ .05). No statistically significant difference was observed in reduction of facial swelling and improvement in mouth opening on 1st, 2nd, and 3rd days postoperatively between both the groups (P ≥ .05). 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) (P < .001).

CONCLUSION AND RELEVANCE: Transbuccal mucoadhesive patch of diclofenac sodium offers effective pain control with quicker analgesia and fewer side effects compared to an oral tablet.