Gingivitis
Conditions
Keywords
gingival inflammation, Nigella sativa, Herbal toothpaste, IL-1β, PGE2, MMP-8
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.
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.
Interventions
DRUGNigella sativa toothpaste
Toothpaste containing 3% Nigella sativa extract used twice daily for three months as part of the experimental intervention.
Toothpaste identical in appearance and taste but without Nigella sativa extract, used twice daily for three months as a comparator.
Sponsors
Universitas Airlangga
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
MALE
Age
18 Years to 50 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in salivary IL-1β levels. | 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. |
| Change in salivary PGE2 levels | 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. |
Countries
Indonesia
Outcome results
None listed