NCT07447349

Effect of Nigella Sativa Toothpaste on Salivary Biomarkers in Patients With Gingivitis

Levels of IL-1β, PGE2, and MMP-8 in Saliva After the Use of Nigella Sativa Toothpaste in Indonesian Army Soldiers With Gingivitis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Universitas Airlangga · Academic / Other
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

This study evaluated the effects of Nigella sativa toothpaste on salivary inflammatory biomarkers (IL-1β, PGE2, and MMP-8) in Indonesian Army personnel with gingivitis. The aim was to determine whether the toothpaste could reduce inflammatory marker levels associated with gingival inflammation.

Detailed description

Gingivitis is an inflammatory condition of the gingiva that is commonly associated with elevated levels of inflammatory biomarkers in saliva. Nigella sativa has been reported to possess anti-inflammatory, antioxidant, and immunomodulatory effects, making it a potential adjunct in gingival inflammation management. This study investigated the effect of Nigella sativa toothpaste on the salivary levels of IL-1β, PGE2, and MMP-8 in Indonesian Army personnel diagnosed with gingivitis. Saliva samples were collected before and after the intervention period. Biomarker concentrations were analyzed to assess the clinical and biochemical response to the use of Nigella sativa toothpaste. The study aimed to determine whether this herbal-based toothpaste could reduce inflammatory biomarkers and provide benefits in managing gingivitis.

Conditions

• Gingivitis

Interventions

Type	Name	Description
DRUG	Nigella sativa toothpaste	Toothpaste containing 3% Nigella sativa extract used twice daily for three months as part of the experimental intervention.
DRUG	Placebo toothpaste	Toothpaste identical in appearance and taste but without Nigella sativa extract, used twice daily for three months as a comparator.

Timeline

• Start date: 2023-01-01
• Primary completion: 2023-06-30
• Completion: 2023-07-31
• First posted: 2026-03-03
• Last updated: 2026-03-03

Locations

1 site across 1 country: Indonesia