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

Universitas Airlangga100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

100

Conditions

Gingivitis

Interventions

Nigella sativa toothpasteDRUG

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

Placebo toothpasteDRUG

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

Eligibility

Sex: MALEMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

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.

Locations (1)

Faculty of Dental Medicine, Universitas Airlangga.

Surabaya, East Java, Indonesia

Outcomes

Primary Outcomes

Change in salivary IL-1β levels.

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

Time frame: Baseline and 3 months of daily toothpaste use

Change in salivary PGE2 levels

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.

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

Data from ClinicalTrials.gov

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