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Trial record 10 of 312 for:    "Periodontitis, Chronic"

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

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ClinicalTrials.gov Identifier: NCT03270280
Recruitment Status : Unknown
Verified August 2017 by Dr. Ghazala Hassan, University of Health Sciences Lahore.
Recruitment status was:  Not yet recruiting
First Posted : September 1, 2017
Last Update Posted : September 1, 2017
Sponsor:
Information provided by (Responsible Party):
Dr. Ghazala Hassan, University of Health Sciences Lahore

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
Chronic Periodontitis 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


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Healthy 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
Estimated Study Start Date : September 11, 2017
Estimated Primary Completion Date : March 11, 2018
Estimated Study Completion Date : April 11, 2018

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Black seed Oil




Primary Outcome Measures :
  1. 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.



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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03270280


Contacts
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Contact: Ghazala Hassan, MPhil +92 320 4635693 mashal_18@hotmail.com
Contact: Sarah Ghafoor, PhD +92 324 4787457 sarahghafoor@uhs.edu.pk

Locations
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Pakistan
Fatima Memorial Hospital
Lahore, Punjab, Pakistan, 0092
Sponsors and Collaborators
University of Health Sciences Lahore
Investigators
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Principal Investigator: Ghazala Hassan, MPhil Research Scholar

Publications:
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Responsible Party: Dr. Ghazala Hassan, Research Scholar, University of Health Sciences Lahore
ClinicalTrials.gov Identifier: NCT03270280     History of Changes
Other Study ID Numbers: UniversityHSL
First Posted: September 1, 2017    Key Record Dates
Last Update Posted: September 1, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data sharing will be considered after the completion of studies

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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, University of Health Sciences Lahore:
Chronic Periodontitis
Phytomedicines
Nigella sativa

Additional relevant MeSH terms:
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Periodontitis
Chronic Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases