Comparison of Salivary Interleukin-1β and Matrix Metalloproteinase-8 Levels in Individuals With Chronic Periodontitis
Primary Purpose
Chronic Periodontitis
Status
Unknown status
Phase
Phase 2
Locations
Pakistan
Study Type
Interventional
Intervention
Nigella Sativa Oil
Normal saline
Sponsored by
About this trial
This is an interventional health services research trial for Chronic Periodontitis focused on measuring Chronic Periodontitis, Phytomedicines, Nigella sativa
Eligibility Criteria
Inclusion Criteria:
- Male and female healthy individual
- Individuals diagnosed with chronic periodontitis according to the WHO criteria.
- Age 19 to 40 years.
Exclusion Criteria:
- 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.
Sites / Locations
- Fatima Memorial Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Normal Saline
Nigella Sativa
Arm Description
The group contains healthy individuals with chronic periodontitis who will receive Normal Saline as placebo
The group contains healthy individuals with chronic periodontitis who will receive Nigella sativa Oil as intervention
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03270280
First Posted
August 29, 2017
Last Updated
August 31, 2017
Sponsor
University of Health Sciences Lahore
1. Study Identification
Unique Protocol Identification Number
NCT03270280
Brief Title
Comparison of Salivary Interleukin-1β and Matrix Metalloproteinase-8 Levels in Individuals With Chronic Periodontitis
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Unknown status
Study Start Date
September 11, 2017 (Anticipated)
Primary Completion Date
March 11, 2018 (Anticipated)
Study Completion Date
April 11, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Health Sciences Lahore
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Periodontitis
Keywords
Chronic Periodontitis, Phytomedicines, Nigella sativa
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Healthy Individuals with Chronic Periodontitis Only
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Triple Blind
Allocation
Randomized
Enrollment
25 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Normal Saline
Arm Type
Placebo Comparator
Arm Description
The group contains healthy individuals with chronic periodontitis who will receive Normal Saline as placebo
Arm Title
Nigella Sativa
Arm Type
Experimental
Arm Description
The group contains healthy individuals with chronic periodontitis who will receive Nigella sativa Oil as intervention
Intervention Type
Drug
Intervention Name(s)
Nigella Sativa Oil
Other Intervention Name(s)
Black seed Oil
Intervention Description
The individuals will apply 55 drops of Nigella sativa Oil on gingivae twice daily for two weeks
Intervention Type
Drug
Intervention Name(s)
Normal saline
Other Intervention Name(s)
Saline
Intervention Description
The individuals will apply 55 drops of Normal saline on gingivae twice daily for two weeks
Primary Outcome Measure Information:
Title
Levels of IL 1-Beta and MMP-8
Description
These inflammatory marker will be measured in patients saliva again after 2 weeks. There will be reduction in their levels.
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Male and female healthy individual
Individuals diagnosed with chronic periodontitis according to the WHO criteria.
Age 19 to 40 years.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ghazala Hassan, MPhil
Phone
+92 320 4635693
Email
mashal_18@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Sarah Ghafoor, PhD
Phone
+92 324 4787457
Email
sarahghafoor@uhs.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ghazala Hassan, MPhil
Organizational Affiliation
Research Scholar
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fatima Memorial Hospital
City
Lahore
State/Province
Punjab
ZIP/Postal Code
0092
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Data sharing will be considered after the completion of studies
Citations:
PubMed Identifier
20339371
Citation
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.
Results Reference
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PubMed Identifier
25098434
Citation
Gupta 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.
Results Reference
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Comparison of Salivary Interleukin-1β and Matrix Metalloproteinase-8 Levels in Individuals With Chronic Periodontitis
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