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

NCT ID: NCT03270280

Last Updated: 2017-09-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-11
• Study Completion Date: 2018-04-11

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

Conditions

Chronic Periodontitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: QUADRUPLE

Study Groups

Normal Saline

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

Group Type: PLACEBO_COMPARATOR

Normal saline

Intervention Type: DRUG

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

Nigella Sativa

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

Group Type: EXPERIMENTAL

Nigella Sativa Oil

Intervention Type: DRUG

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

Interventions

Nigella Sativa Oil

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

Intervention Type: DRUG

Normal saline

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

Intervention Type: DRUG

Other Intervention Names

Black seed Oil; Saline

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.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Health Sciences Lahore

OTHER

Sponsor Role: lead

Responsible Party

Dr. Ghazala Hassan

Research Scholar

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ghazala Hassan, MPhil

Role: PRINCIPAL_INVESTIGATOR

Research Scholar

Locations

Fatima Memorial Hospital

Lahore, Punjab Province, Pakistan

Countries

Pakistan

Central Contacts

Ghazala Hassan, MPhil

Role: CONTACT

mashal_18@hotmail.com

+92 320 4635693

Sarah Ghafoor, PhD

Role: CONTACT

sarahghafoor@uhs.edu.pk

+92 324 4787457

References

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.

Reference Type: BACKGROUND

PMID: 20339371 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25098434 (View on PubMed)

Other Identifiers

UniversityHSL

Identifier Type: -

Identifier Source: org_study_id