Effect of Nigella Sativa Toothpaste on Salivary Biomarkers in Patients With Gingivitis (NS-GINGIVITIS)

February 27, 2026 updated by: Yonathan Stiawan, Universitas Airlangga

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • East Java
      • Surabaya, East Java, Indonesia, 60132
        • Faculty of Dental Medicine, Universitas Airlangga.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Group: Nigella sativa Toothpaste
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
Toothpaste containing 3% Nigella sativa extract used twice daily for three months as part of the experimental intervention.
Placebo Comparator: Control Group: Placebo Toothpaste
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
Toothpaste identical in appearance and taste but without Nigella sativa extract, used twice daily for three months as a comparator.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and 3 months of daily toothpaste use
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.
Baseline and 3 months of daily toothpaste use.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitas Airlangga

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Actual)

June 30, 2023

Study Completion (Actual)

July 31, 2023

Study Registration Dates

First Submitted

January 18, 2026

First Submitted That Met QC Criteria

February 27, 2026

First Posted (Actual)

March 3, 2026

Study Record Updates

Last Update Posted (Actual)

March 3, 2026

Last Update Submitted That Met QC Criteria

February 27, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UA-PERIO-NS-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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