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

Chronic Periodontitis Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03270280
• Other study ID #: UniversityHSL
• Status: Not yet recruiting
• Phase: Phase 2
• First received: August 29, 2017
• Last updated: August 31, 2017
• Start date: September 11, 2017
• Est. completion date: April 11, 2018

Study information

• Verified date: August 2017
• Source: University of Health Sciences Lahore
• Contact: Ghazala Hassan, MPhil
• Phone: +92 320 4635693
• Email: mashal_18[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 25
• Est. completion date: April 11, 2018
• Est. primary completion date: March 11, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Periodontitis
• Periodontitis

Intervention

Drug:
• Nigella Sativa Oil
The individuals will apply 55 drops of Nigella sativa Oil on gingivae twice daily for two weeks
• Normal saline
The individuals will apply 55 drops of Normal saline on gingivae twice daily for two weeks

Locations

Country	Name	City	State
Pakistan	Fatima Memorial Hospital	Lahore	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
University of Health Sciences Lahore

Country where clinical trial is conducted

Pakistan, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 weeks