GingivitisNS-GINGIVITISNCT07447349
Effect of Nigella Sativa Toothpaste on Salivary Biomarkers in Patients With Gingivitis
A study testing Nigella sativa toothpaste in people with Gingivitis, run by Universitas Airlangga at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men only
- Conditions the study is for
- Gingivitis
- What is being tested?
- Nigella sativa toothpaste
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Jan 2023to 31 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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%.
Who cannot join
- Subjects who do not meet the inclusion criteria or are unwilling to provide written informed consent.
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Faculty of Dental Medicine, Universitas Airlangga.
Surabaya, East Java, 60132
About this study
Official title: 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.
Read the 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.
- Conditions
- Gingivitis
- Being tested
- Nigella sativa toothpaste, Placebo toothpaste
- Keywords
- gingival inflammation, Nigella sativa, Herbal toothpaste, IL-1β, PGE2, MMP-8
- Medical subject headings
- Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebo toothpaste |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline and 3 months of daily toothpaste use.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start1 Jan 2023
- Primary completion30 Jun 2023
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GingivitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Airlangga
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yonathan Stiawan, Universitas Airlangga
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07447349
- Sponsor's protocol ID
- UA-PERIO-NS-001
- Acronym
- NS-GINGIVITIS
- Status last verified
- Feb 2026
- First submitted
- 18 Jan 2026
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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
Publications
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.
PubMed 38744331
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Levels of IL-1β, PGE2, and MMP-8 in Saliva After the Use of Nigella Sativa Toothpaste in Indonesian Army Soldiers With Gingivitis
- ClinicalTrials.gov ID
- NCT07447349
- Acronym / sponsor ID
- NS-GINGIVITIS / UA-PERIO-NS-001
- Conditions
- Gingivitis
- Keywords
- gingival inflammation, Nigella sativa, Herbal toothpaste, IL-1β, PGE2, MMP-8
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Universitas AirlanggaUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 3 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group: Nigella sativa Toothpaste | Experimental | Drug: Nigella sativa toothpasteParticipants 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. |
| Control Group: Placebo Toothpaste | Placebo comparator | Drug: Placebo toothpasteParticipants 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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%.
Key exclusion criteria (1 listed)
- Subjects who do not meet the inclusion criteria or are unwilling to provide written informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nigella sativa toothpasteToothpaste containing 3% Nigella sativa extract used twice daily for three months as part of the experimental intervention. | Drug | Experimental Group: Nigella sativa Toothpaste |
| Placebo toothpasteToothpaste identical in appearance and taste but without Nigella sativa extract, used twice daily for three months as a comparator. | Drug | Control Group: Placebo Toothpaste |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
- Results publication: PubMed 38744331Maduratna 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.
- Individual participant dataSharing planned: No. 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
Related trials for Gingivitis
Enrolling by invitation
Comparison of the Effects of Oral Hygiene Regimens on Clinical, Immunomodulatory, and Microbial Outcomes and Oral Tolerance in People With Gingivitis
Microbiome, Cytokines
Active, not recruitingPhase 3
A Study to Assess the Efficacy of Two Brushing Regimens in the Reduction of Established Dental Plaque and Gingivitis
Plaque, Gingivitis
Not yet recruiting
Effectiveness of Personalized Digital Oral Health Intervention in Patients With Fixed Orthodontic Appliances.
Oral Hygiene in Patients With Fixed Orthodontic Appliances, Dental Plaque
Not yet recruitingPhase 2
Efficacy of Thymus Vulgaris Mouthwash in the Management of Biofilm-Induced Gingivitis
Plaque-Induced Gingivitis
Not yet recruitingPhase 3
Periodontal Disease and Small Vulnerable Newborns in Rural Nepal: A Community-based Trial
Preterm Birth, Low Birth Weight
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nigella sativa toothpaste in people with Gingivitis, run by Universitas Airlangga at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in salivary IL-1β levels. (time frame: Baseline and 3 months of daily toothpaste use). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07447349, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2026.