Comparison of Salivary Interleukin-1β and Matrix Metalloproteinase-8 Levels in Individuals With Chronic Periodontitis
1 other identifier
interventional
25
1 country
1
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Sep 2017
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 29, 2017
CompletedFirst Posted
Study publicly available on registry
September 1, 2017
CompletedStudy Start
First participant enrolled
September 11, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 11, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
April 11, 2018
CompletedSeptember 1, 2017
August 1, 2017
6 months
August 29, 2017
August 31, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
2 weeks
Study Arms (2)
Normal Saline
PLACEBO COMPARATORThe group contains healthy individuals with chronic periodontitis who will receive Normal Saline as placebo
Nigella Sativa
EXPERIMENTALThe group contains healthy individuals with chronic periodontitis who will receive Nigella sativa Oil as intervention
Interventions
The individuals will apply 55 drops of Nigella sativa Oil on gingivae twice daily for two weeks
The individuals will apply 55 drops of Normal saline on gingivae twice daily for two weeks
Eligibility Criteria
You may qualify if:
- Male and female healthy individual
- Individuals diagnosed with chronic periodontitis according to the WHO criteria.
- Age 19 to 40 years.
You may not qualify if:
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fatima Memorial Hospital
Lahore, Punjab Province, 0092, Pakistan
Related Publications (2)
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.
PMID: 20339371BACKGROUNDGupta 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.
PMID: 25098434BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ghazala Hassan, MPhil
Research Scholar
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Triple Blind
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Scholar
Study Record Dates
First Submitted
August 29, 2017
First Posted
September 1, 2017
Study Start
September 11, 2017
Primary Completion
March 11, 2018
Study Completion
April 11, 2018
Last Updated
September 1, 2017
Record last verified: 2017-08
Data Sharing
- IPD Sharing
- Will not share
Data sharing will be considered after the completion of studies