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.

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.

Inclusion Criteria:

• Indonesian Army (TNI) soldiers from the 202 Tajimalela Mechanized Infantry Battalion.
• Diagnosed with gingivitis and periodontitis.
• Aged 18-50 years.
• Minimum of 20 teeth (excluding third molars).
• Bleeding on Probing (BoP) score of ≥ 10%.

Exclusion Criteria:

• Subjects who do not meet the inclusion criteria or are unwilling to provide written informed consent.

The participants of this study are exclusively male because the research was conducted among active-duty soldiers of the Indonesian National Armed Forces (TNI) at the 202 Tajimalela Mechanized Infantry Battalion, where the available subject population meeting the military criteria at the study site was male. This approach ensures a more homogeneous study population regarding lifestyle and physical activity levels.

There is no plan to share individual participant data (IPD) to the public. The study results are presented in aggregate form within the manuscript to maintain the confidentiality of the participants, who are active-duty military personnel. Any inquiries regarding the data may be directed to the corresponding author

This is a double-blind study where both the participants and the investigators are unaware of the group assignments. The treatment group received toothpaste containing 3% Nigella sativa, while the control group received a placebo toothpaste that was identical in appearance and packaging to ensure masking.