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

Comparison of Salivary Interleukin-1β and Matrix Metalloproteinase-8 Levels in Individuals With Chronic Periodontitis Before and After Treatment With Nigella Sativa (Kalonji) Oil

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03270280
Enrollment
25
Registered
2017-09-01
Start date
2017-09-11
Completion date
2018-04-11
Last updated
2017-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Periodontitis

Keywords

Chronic Periodontitis, Phytomedicines, Nigella sativa

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

Interventions

DRUGNormal saline

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

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

Sponsors

University of Health Sciences Lahore
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

Triple Blind

Intervention model description

Healthy Individuals with Chronic Periodontitis Only

Eligibility

Sex/Gender
ALL
Age
19 Years to 40 Years
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

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Levels of IL 1-Beta and MMP-82 weeksThese inflammatory marker will be measured in patients saliva again after 2 weeks. There will be reduction in their levels.

Countries

Pakistan

Contacts

Primary ContactGhazala Hassan, MPhil
mashal_18@hotmail.com+92 320 4635693
Backup ContactSarah Ghafoor, PhD
sarahghafoor@uhs.edu.pk+92 324 4787457

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026