Clinical Efficacy of a Novel Lipid-based Thymoquinone Gel: A Two-arm, Single-blinded, and Randomized Study

To evaluate the clinical efficacy of topical 0.1% lipid-based Thymoquinone (TQ) gel, as an antiplaque and antigingivitis agent.

A randomized clinical trial was carried out in the Outpatient Department of Pediatric and Preventive Dentistry, Dr. Z.A. Dental College, India with a purposive sample of 60 healthy children of 12-18 years of age, having a gingival and plaque index ≥1; the children were divided into two groups by simple randomization. Group A (30 subjects) was advised to apply peanut amount of Chlorhexidine (CHX) gel, twice a day for 2min. Group B (30 subjects) was advised the same but with a peanut amount of 0.1% lipid-based TQ gel. The clinical parameters were the recording of plaque and gingival indices, prior to the treatment (baseline) and at the 14th and 28th day, respectively (post-treatment). The total duration of the study was 28 days with follow-up.

Data analysis was done by employing IBM Statistical Package for Social Sciences Windows software, version 20 (IBM Corp, Armonk, NY, USA). The 0.1% lipid-based TQ gel had a statistically significant reduction (P < 0.001) in plaque index as compared with CHX gel during the 0-14th day and 0-28th day, respectively. Similarly, 0.1% lipid-based TQ gel showed a statistically significant reduction in gingival index (P = 0.005) during the 0-14th day and a statistically significant reduction during the 0-28th day (P < 0.001), as compared with CHX gel.

Statistically significant reduction in plaque (P < 0.001) and gingival index (P < 0.001) with the usage of 0.1% lipid-based TQ gel.