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

NCT07447349 | Completed

• 1 other identifier: UA-PERIO-NS-001
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gingivitis

Keywords

gingival inflammation; Nigella sativa; Herbal toothpaste; IL-1β; PGE2; MMP-8

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Baseline and 3 months of daily toothpaste use.

Study Arms (2)

Experimental Group: Nigella sativa Toothpaste

EXPERIMENTAL

Participants in this group used toothpaste containing 3% Nigella sativa extract twice daily for three months, along with standardized oral hygiene education, to evaluate its effect on salivary inflammatory biomarkers.

Drug: Nigella sativa toothpaste

Control Group: Placebo Toothpaste

PLACEBO COMPARATOR

Participants in this group used a placebo toothpaste identical in appearance and taste but without Nigella sativa extract twice daily for three months, along with standardized oral hygiene education, as a comparison group.

Drug: Placebo toothpaste

Interventions

Nigella sativa toothpaste DRUG

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

Experimental Group: Nigella sativa Toothpaste

Placebo toothpaste DRUG

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

Control Group: Placebo Toothpaste

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: 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.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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%.

Sponsors & Collaborators

• Universitas Airlangga: lead

Study Sites (1)

Faculty of Dental Medicine, Universitas Airlangga.

Surabaya, East Java, 60132, Indonesia

Location

Related Publications (1)

• Maduratna E, Sari DS, Rahayu RP, Masya RN, Adinar N. The Anti-Inflammatory Effect of Nigella sativa Toothpaste on Porphyromonas gingivalis Bacteria Through Decreased TNF-alpha, MMP-9, PGE-2 Expression in Wistar Rats. Eur J Dent. 2024 Jul;18(3):808-814. doi: 10.1055/s-0043-1772700. Epub 2024 May 14.

  PMID: 38744331 RESULT

MeSH Terms

Conditions

Gingivitis

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Department of Periodontology

Model Details: Participants were divided into two parallel groups using a randomized allocation based on registration numbers (odd numbers for the treatment group and even numbers for the control group). The treatment group used toothpaste containing 3% Nigella sativa, while the control group used a placebo toothpaste. Both groups used the assigned toothpaste daily for a duration of three months.

Study Record Dates

• First Submitted: January 18, 2026
• First Posted: March 3, 2026
• Study Start: January 1, 2023
• Primary Completion: June 30, 2023
• Study Completion: July 31, 2023
• Last Updated: March 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)