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Completed

NCT Number: NCT07447349

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

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.

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Key information

Conditions

Gingivitis Gingival Diseases Infections Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dental Medicine, Universitas Airlangga.

Surabaya, East Java, 60132, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nigella sativa toothpaste

Drug

Toothpaste containing 3% Nigella sativa extract used twice daily for three months as part of the experimental intervention.

Placebo toothpaste

Drug

Toothpaste identical in appearance and taste but without Nigella sativa extract, used twice daily for three months as a comparator.

Primary outcomes

  1. Change in salivary IL-1β levels.

    Time frame: Baseline and 3 months of daily toothpaste use

    Measuring the concentration of Interleukin-1 beta (IL-1β) in saliva samples using the enzyme-linked immunosorbent assay (ELISA) method to evaluate inflammatory response.

  2. Change in salivary PGE2 levels

    Time frame: Baseline and 3 months of daily toothpaste use.

    Measuring the concentration of Prostaglandin E2 (PGE2) in saliva samples using the enzyme-linked immunosorbent assay (ELISA) method to evaluate the reduction of inflammatory mediators.

Sponsors and collaborators

Lead sponsor

Universitas Airlangga

Other

Registry information

Official study title

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

Acronym: NS-GINGIVITIS

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Mar 3, 2026
Registry last updated
Mar 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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