Chronic PeriodontitisPhase 2NCT03270280
Comparison of Salivary Interleukin-1β and Matrix Metalloproteinase-8 Levels in Individuals With Chronic Periodontitis
A Phase 2 study testing Nigella Sativa Oil and Normal saline in people with Chronic Periodontitis, run by University of Health Sciences Lahore at 1 site in Pakistan.
Trial summary
Periodontitis is an infectious inflammatory disease affecting the periodontal tissue (Gingivae, alveolar bone, periodontal ligament and cementum). Chronic Periodontitis is considered to be the most prevalent disease after dental caries which is linked to increased levels of C- reactive protein, interleukins and matrix… Read more about this study
- Who is it for?
- Ages 19 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Periodontitis
- What is being tested?
- Nigella Sativa Oil and Normal saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 sitePakistan
- Study dates
- 11 Sep 2017to 11 Apr 2018
- Phase
- Phase 2
- 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 19 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male and female healthy individual
- Individuals diagnosed with chronic periodontitis according to the WHO criteria.
- Age 19 to 40 years.
Who cannot join
- Patients with gingivitis only.
- Patients using tobacco products and alcohol.
- Underlying systemic pathology such as diabetes mellitus, cardiovascular disease, arthritis etc.
- Oral mucosal pre-neoplastic lesions (leukoplakia, erthroplakia, lichen planus) and oral carcinomas.
- Obese patients.
- Pregnant females.
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- Xerostomia.
- Previous history of radiotherapy or chemotherapy.
- Positive history of oral prophylactic procedures (mouthwashes and antibiotics).
- Positive history of any periodontal treatment during last 6 months.
- Positive antibiotic therapy history within last month of study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Salivary Interleukin-1β and Matrix Metalloproteinase-8 Levels in Individuals With Chronic Periodontitis Before and After Treatment With Nigella Sativa (Kalonji) Oil
Periodontitis is an infectious inflammatory disease affecting the periodontal tissue (Gingivae, alveolar bone, periodontal ligament and cementum). Chronic Periodontitis is considered to be the most prevalent disease after dental caries which is linked to increased levels of C- reactive protein, interleukins and matrix metallo-proteinases. Interleukin- 1β and Matrix metalloproteinase-8 have been shown to be robust markers of inflammatory cascade of chronic periodontitis.Various treatment modalities including scaling and root planing, toothpastes and chlorhexidine based mouthwashes have been are known to be associated with various side effects like teeth staining, altered taste sensation, mucosal burning. Hence,the use of natural medicaments could provide a better alternative because of their fewer side effects and cost effectiveness.
Read the detailed description
Periodontal disease is one of the most common diseases in humans and is responsible for most of the tooth loss in adults. World health Organisation report of 2005 described that the global problem persisted with the worldwide oral diseases such as dental caries, periodontal disease, tooth loss, oral mucosal lesions and oro-pharyngeal cancer. According to a local study the prevalence of periodontitis is found to be more in males of older age group and more in rural areas owing to the lack of awareness of importance of oral hygiene.
Apart from various conventional treatment option for periodontitis a number of herbal medicinal intervention have been used for its treatment. Plant extracts and herbs that have been used previously used for periodontal therapy include Salvadora persica, Arnica Montana and Hamamelis virginiana which have been shown to exhibit antibacterial activity against periodonto-pathic bacteria. Phytomedicines (Medicines derived from herbal plants) like indian gum arabic, aloe vera, nim, carvacrol, garlic, wild coffee and propolis resin have been used in dentistry as anti-inflammatory, antibiotics, analgesic and hypnotic agents. Propolis resin, guava and triphala have been also been used for the treatment of periodontitis
- Conditions
- Chronic Periodontitis
- Being tested
- Nigella Sativa Oil, Normal saline
- Keywords
- Chronic Periodontitis, Phytomedicines, Nigella sativa
- Medical subject headings
- Chronic Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nigella Sativa OilDrug
Also called Black seed Oil
The individuals will apply 55 drops of Nigella sativa Oil on gingivae twice daily for two weeks
Normal salineDrug
Also called Saline
The individuals will apply 55 drops of Normal saline on gingivae twice daily for two weeks
| Study group | Role | What they receive |
|---|---|---|
| Normal Saline | Placebo comparator | The group contains healthy individuals with chronic periodontitis who will receive Normal Saline as placebo Receives: Drug: Normal saline |
| Nigella Sativa | Experimental | The group contains healthy individuals with chronic periodontitis who will receive Nigella sativa Oil as intervention Receives: Drug: Nigella Sativa Oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Levels of IL 1-Beta and MMP-8
These inflammatory marker will be measured in patients saliva again after 2 weeks. There will be reduction in their levels.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2017
- Study start11 Sep 2017 (estimated)
- Primary completion11 Mar 2018 (estimated)
- Study completion11 Apr 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic PeriodontitisStudies of the same condition, open and under way.
- More trials run by University of Health Sciences LahoreThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Healthy Individuals with Chronic Periodontitis Only
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Health Sciences Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Ghazala Hassan, University of Health Sciences Lahore
- Investigators
- Ghazala Hassan, MPhil, Principal investigator, Research Scholar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03270280
- Sponsor's protocol ID
- UniversityHSL
- Status last verified
- Aug 2017
- First submitted
- 29 Aug 2017
- Last updated
- 1 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data sharing will be considered after the completion of studies
Publications
Zadik Y, Bechor R, Galor S, Levin L. Periodontal disease might be associated even with impaired fasting glucose. Br Dent J. 2010 May 22;208(10):E20. doi: 10.1038/sj.bdj.2010.291. Epub 2010 Mar 26.
PubMed 20339371Gupta N, Gupta ND, Gupta A, Khan S, Bansal N. Role of salivary matrix metalloproteinase-8 (MMP-8) in chronic periodontitis diagnosis. Front Med. 2015 Mar;9(1):72-6. doi: 10.1007/s11684-014-0347-x. Epub 2014 Aug 6.
PubMed 25098434
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Salivary Interleukin-1β and Matrix Metalloproteinase-8 Levels in Individuals With Chronic Periodontitis Before and After Treatment With Nigella Sativa (Kalonji) Oil
- ClinicalTrials.gov ID
- NCT03270280
- Acronym / sponsor ID
- UniversityHSL
- Conditions
- Chronic Periodontitis
- Keywords
- Chronic Periodontitis, Phytomedicines, Nigella sativa
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University of Health Sciences LahoreUniversity, hospital or other
- Study start
- 11 Sep 2017 (estimated)
- Primary completion
- 11 Mar 2018 (estimated)
- Study completion
- 11 Apr 2018 (estimated)
- First posted
- 1 Sep 2017 (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.
Periodontitis is an infectious inflammatory disease affecting the periodontal tissue (Gingivae, alveolar bone, periodontal ligament and cementum). Chronic Periodontitis is considered to be the most prevalent disease after dental caries which is linked to increased levels of C- reactive protein, interleukins and matrix metallo-proteinases. Interleukin- 1β and Matrix metalloproteinase-8 have been shown to be robust markers of inflammatory cascade of chronic periodontitis.Various treatment modalities including scaling and root planing, toothpastes and chlorhexidine based mouthwashes have been are known to be associated with various side effects like teeth staining, altered taste sensation, mucosal burning. Hence,the use of natural medicaments could provide a better alternative because of their fewer side effects and cost effectiveness.
Detailed description
Periodontal disease is one of the most common diseases in humans and is responsible for most of the tooth loss in adults. World health Organisation report of 2005 described that the global problem persisted with the worldwide oral diseases such as dental caries, periodontal disease, tooth loss, oral mucosal lesions and oro-pharyngeal cancer. According to a local study the prevalence of periodontitis is found to be more in males of older age group and more in rural areas owing to the lack of awareness of importance of oral hygiene.
Apart from various conventional treatment option for periodontitis a number of herbal medicinal intervention have been used for its treatment. Plant extracts and herbs that have been used previously used for periodontal therapy include Salvadora persica, Arnica Montana and Hamamelis virginiana which have been shown to exhibit antibacterial activity against periodonto-pathic bacteria. Phytomedicines (Medicines derived from herbal plants) like indian gum arabic, aloe vera, nim, carvacrol, garlic, wild coffee and propolis resin have been used in dentistry as anti-inflammatory, antibiotics, analgesic and hypnotic agents. Propolis resin, guava and triphala have been also been used for the treatment of periodontitis
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Healthy Individuals with Chronic Periodontitis Only
| Arm | Type | Receives |
|---|---|---|
| Normal Saline | Placebo comparator | Drug: Normal salineThe group contains healthy individuals with chronic periodontitis who will receive Normal Saline as placebo |
| Nigella Sativa | Experimental | Drug: Nigella Sativa OilThe group contains healthy individuals with chronic periodontitis who will receive Nigella sativa Oil as intervention |
Who may qualify
- Ages
- 19 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male and female healthy individual
- Individuals diagnosed with chronic periodontitis according to the WHO criteria.
- Age 19 to 40 years.
Key exclusion criteria (11 listed)
- Patients with gingivitis only.
- Patients using tobacco products and alcohol.
- Underlying systemic pathology such as diabetes mellitus, cardiovascular disease, arthritis etc.
- Oral mucosal pre-neoplastic lesions (leukoplakia, erthroplakia, lichen planus) and oral carcinomas.
- Obese patients.
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 OilAlso: Black seed OilThe individuals will apply 55 drops of Nigella sativa Oil on gingivae twice daily for two weeks | Drug | Nigella Sativa |
| Normal salineAlso: SalineThe individuals will apply 55 drops of Normal saline on gingivae twice daily for two weeks | Drug | Normal Saline |
Primary outcome
Levels of IL 1-Beta and MMP-8
Time frame: 2 weeks
These inflammatory marker will be measured in patients saliva again after 2 weeks. There will be reduction in their levels.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2017.
- Background: PubMed 20339371Zadik Y, Bechor R, Galor S, Levin L. Periodontal disease might be associated even with impaired fasting glucose. Br Dent J. 2010 May 22;208(10):E20. doi: 10.1038/sj.bdj.2010.291. Epub 2010 Mar 26.
- Background: PubMed 25098434Gupta N, Gupta ND, Gupta A, Khan S, Bansal N. Role of salivary matrix metalloproteinase-8 (MMP-8) in chronic periodontitis diagnosis. Front Med. 2015 Mar;9(1):72-6. doi: 10.1007/s11684-014-0347-x. Epub 2014 Aug 6.
- Individual participant dataSharing planned: No. Data sharing will be considered after the completion of studies
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Prevalence and Associated Factors of High BMI and Periodontitis in Thai Adults Aged Under 60 Years
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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.
Ghazala Hassan, MPhil principal investigator
Research Scholar
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nigella Sativa Oil and Normal saline in people with Chronic Periodontitis, run by University of Health Sciences Lahore at 1 site in Pakistan.
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 3 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 1 Sep 2017. 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 Pakistan. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ghazala Hassan, MPhil (+92 320 4635693, mashal_18@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Levels of IL 1-Beta and MMP-8 (time frame: 2 weeks). 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 NCT03270280, which also lists 2 linked publications.
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 1 Sep 2017.