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Comparison of Salivary Interleukin-1β and Matrix Metalloproteinase-8 Levels in Individuals With Chronic Periodontitis

Sponsor
University of Health Sciences Lahore (Other)
Overall Status
Unknown status
CT.gov ID
NCT03270280
Collaborator
(none)
25
Enrollment
1
Location
2
Arms
7
Anticipated Duration (Months)
3.6
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Nigella Sativa Oil
  • Drug: Normal saline
 Phase 2

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

Study Type:
Interventional
Anticipated Enrollment :
25 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Healthy Individuals with Chronic Periodontitis OnlyHealthy Individuals with Chronic Periodontitis Only
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Triple Blind
Primary Purpose:
Health Services Research
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
Anticipated Study Start Date :
Sep 11, 2017
Anticipated Primary Completion Date :
Mar 11, 2018
Anticipated Study Completion Date :
Apr 11, 2018

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Normal Saline

The group contains healthy individuals with chronic periodontitis who will receive Normal Saline as placebo

Drug: Normal saline
The individuals will apply 55 drops of Normal saline on gingivae twice daily for two weeks
Other Names:
  • Saline

    		•
    Experimental: Nigella Sativa

    The group contains healthy individuals with chronic periodontitis who will receive Nigella sativa Oil as intervention

    Drug: Nigella Sativa Oil
    The individuals will apply 55 drops of Nigella sativa Oil on gingivae twice daily for two weeks
    Other Names:
  • Black seed Oil

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Levels of IL 1-Beta and MMP-8 [2 weeks]

      These inflammatory marker will be measured in patients saliva again after 2 weeks. There will be reduction in their levels.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years to 40 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Fatima Memorial Hospital Lahore Punjab Pakistan 0092

    Sponsors and Collaborators

    • University of Health Sciences Lahore

    Investigators

    • Principal Investigator: Ghazala Hassan, MPhil, Research Scholar

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Dr. Ghazala Hassan, Research Scholar, University of Health Sciences Lahore
    ClinicalTrials.gov Identifier:
    NCT03270280
    Other Study ID Numbers:
    • UniversityHSL
    First Posted:
    Sep 1, 2017
    Last Update Posted:
    Sep 1, 2017
    Last Verified:
    Aug 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Keywords provided by Dr. Ghazala Hassan, Research Scholar, University of Health Sciences Lahore
    Chronic Periodontitis
    Phytomedicines
    Nigella sativa
    Additional relevant MeSH terms:
    Periodontitis
    Chronic Periodontitis

    Study Results

    No Results Posted as of Sep 1, 2017