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Status unknownNCT03270280Updated Sep 1, 2017

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

A Phase 2 interventional study of Nigella Sativa Oil and Normal saline in Chronic Periodontitis, sponsored by University of Health Sciences Lahore. Status unknown at 1 site in Pakistan. Open to participants aged 19 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-09-01.

Sponsored by University of Health Sciences Lahore · Phase 2, Interventional, and Health services research

The sponsor has not verified this record recently (last verified Aug 2017), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
25
Allocation
Randomized
Ages
19 Years to 40 Years
Sex
All
01

Study 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.

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

02

Conditions studied

  • Chronic Periodontitis

Keywords

  • Chronic Periodontitis
  • Phytomedicines
  • Nigella sativa
03

Who can participate

Ages eligible
19 Years to 40 Years
Sexes eligible
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

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.
04

Study design

Phase
Phase 2
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
25 participants (estimated)

Study arms

  • Placebo comparator
    Normal Saline

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

    Drug: Normal saline

  • Experimental
    Nigella Sativa

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

    Drug: Nigella Sativa Oil

Interventions

  • DrugNigella Sativa Oil

    The individuals will apply 55 drops of Nigella sativa Oil on gingivae twice daily for two weeks

    Also known as: Black seed Oil

  • DrugNormal saline

    The individuals will apply 55 drops of Normal saline on gingivae twice daily for two weeks

    Also known as: Saline

05

What researchers measure

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.

    Time frame: 2 weeks

06

Study locations

1 site
  • Fatima Memorial Hospital
    Lahore, Punjab 0092, Pakistan
07

References and documents

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 20339371 ↗
  • 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. PubMed 25098434 ↗

Individual participant data

Plan to share: No — Data sharing will be considered after the completion of studies

08

Registry details

Key details

Study ID
NCT03270280
Lead sponsor
University of Health Sciences Lahore
Responsible party
Dr. Ghazala Hassan (Research Scholar, University of Health Sciences Lahore) — Principal investigator
First posted
Sep 1, 2017
Start date
Sep 11, 2017 (estimated)
Primary completion
Mar 11, 2018 (estimated)
Completion
Apr 11, 2018 (estimated)
Last update
Sep 1, 2017

Study contacts

Ghazala Hassan, MPhil
Contact
mashal_18@hotmail.com
+92 320 4635693
Sarah Ghafoor, PhD
Contact
sarahghafoor@uhs.edu.pk
+92 324 4787457
Ghazala Hassan, MPhil
principal investigator · Research Scholar

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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