Efficacy and Safety of a Novel Oil Pulling Oral Rinse for Teeth Whitening: A Double-Blind, Randomised, Placebo-Controlled Trial.

Aim Conventional peroxide-based tooth-whitening systems are effective but are frequently associated with tooth sensitivity and gingival irritation, prompting interest in potentially gentler alternatives. Medium-chain triglyceride (MCT) oil combined with essential oils has been proposed as a possible approach to reducing extrinsic tooth discolouration, but controlled clinical evidence remains limited. This study aimed to evaluate the whitening efficacy and safety of a novel MCT-based oil pulling oral rinse containing an essential oil blend compared with a placebo in adults with tooth shade A2 or darker. Materials and methods In this double-blind, randomised, placebo-controlled, single-centre trial, 100 adults (18-65 years) with a baseline tooth shade of A2 or darker were randomised 1:1 to receive the active oil pulling rinse (n=50) or a matched placebo rinse (n=50). Participants self-administered 10 mL of the assigned rinse each morning before toothbrushing for 4 weeks. Tooth shade was assessed at screening, Week 2, and Week 4 using a VITA classical shade guide (VITA Zahnfabrik, Bad Säckingen, Germany), converted to a 16-point Munsell-based numeric scale, and compared between groups using the Wilcoxon test. Safety was assessed through physical and oral examination, vital signs, haematology and biochemistry, and adverse event monitoring. Results All 100 randomised participants completed the study with no dropouts or protocol deviations. Mean (SD) tooth-whiteness scores in the active group increased from 5.99 (2.627) at screening to 6.97 (2.769) at Week 2 and 7.29 (2.832) at Week 4, whereas placebo scores remained essentially unchanged (6.16 (2.419) at screening, 6.16 (2.421) at Week 2, - 6.22 (2.462)) at Week 4. Between-group differences favoured the active rinse at Week 2 and Week 4 (both p<0.0001), with continued significant improvement between Week 2 and Week 4 (p=0.0008). Treatment compliance was 100% in both arms; 92% of active-group and 90% of placebo-group participants rated tolerability as excellent. No adverse events and no clinically significant changes in physical examination, oral examination, vital signs, or laboratory parameters were observed in either group. Satisfaction with treatment was markedly higher in the active group. Conclusion The active oil pulling oral rinse containing MCT oil and an essential oil blend produced statistically significant, progressive improvement in tooth whiteness over four weeks compared with placebo, with an excellent safety and tolerability profile. These findings support the investigated oil pulling rinse as a viable, gentle adjunct for cosmetic tooth whitening, although confirmation in larger, multi-centre studies is warranted.