Clinical trial NCT03270280: 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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Chronic Periodontitis
Keywords: Chronic Periodontitis
Phytomedicines
Nigella sativa
Lead sponsor: University of Health Sciences Lahore
Sponsor class: OTHER
First posted: 2017-09-01
Enrollment: 25
Sex: ALL
Minimum age (years): 19
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Healthy Individuals with Chronic Periodontitis Only
Primary purpose: HEALTH_SERVICES_RESEARCH

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

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.

Primary outcomes:
measure: Levels of IL 1-Beta and MMP-8
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Fatima Memorial Hospital
state: Punjab
Study officials:
affiliation: Research Scholar
name: Ghazala Hassan, MPhil
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.