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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 16 December 2017
Main ID:  NCT03270280
Date of registration: 29/08/2017
Prospective Registration: Yes
Primary sponsor: University of Health Sciences Lahore
Public title: Comparison of Salivary Interleukin-1ß and Matrix Metalloproteinase-8 Levels in Individuals With Chronic Periodontitis
Scientific title: Comparison of Salivary Interleukin-1ß and Matrix Metalloproteinase-8 Levels in Individuals With Chronic Periodontitis Before and After Treatment With Nigella Sativa (Kalonji) Oil
Date of first enrolment: September 11, 2017
Target sample size: 25
Recruitment status: Not yet recruiting
URL:  https://clinicaltrials.gov/show/NCT03270280
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Health Services Research. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).  
Phase:  Phase 2
Countries of recruitment
Pakistan
Contacts
Name:     Ghazala Hassan, MPhil
Address: 
Telephone:
Email:
Affiliation:  Research Scholar
Name:     Ghazala Hassan, MPhil
Address: 
Telephone: +92 320 4635693
Email: mashal_18@hotmail.com
Affiliation: 
Key inclusion & exclusion 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.



Age minimum: 19 Years
Age maximum: 40 Years
Gender: All
Health Condition(s) or Problem(s) studied
Chronic Periodontitis
Intervention(s)
Drug: Normal saline
Drug: Nigella Sativa Oil
Primary Outcome(s)
Levels of IL 1-Beta and MMP-8 [Time Frame: 2 weeks]
Secondary Outcome(s)
Secondary ID(s)
UniversityHSL
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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