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NCT02159781 Clinical Trial

Effect of Periodontal Treatment on Salivary Biomarkers

Chronic Periodontitis Clinical Trial

Official title:
Effect of Periodontal Treatment on Salivary Biomarkers.

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT02159781
Other study ID # 2013-1476.CTIL
Secondary ID
Status Not yet recruiting
Phase N/A
First received May 28, 2014
Last updated June 9, 2014
Start date July 2014
Est. completion date September 2016

Study information
Verified date June 2014
Source The Baruch Padeh Medical Center, Poriya
Contact Eran Front, DMD
Phone +97246652254
Email efront@poria.health.gov.il
Is FDA regulated No
Health authority Israel: The Israel National Institute for Health Policy Research and Health Services Research
Study type Interventional

Clinical Trial Summary

The investigators plan to recruit 40 healthy patients referred to the unit of Periodontology, diagnosed with generalized moderate - severe chronic periodontitis.

treatment will include 4 - 6 sessions of scaling + root planning, oral hygiene instructions and motivation.

Whole saliva will be collected at intake and 8 - 14 weeks post periodontal treatment.

Saliva will be analyzed for trans locator protein. Study hypothesis: Periodontal treatment has an affect on saliva components.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 60
Est. completion date September 2016
Est. primary completion date September 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- healthy patients

- moderate - sever chronic periodontitis

Exclusion Criteria:

- systemic disease

- pregnancy

- subjects under the age of 18

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

Procedure:
• periodontal treatment - scaling and root planning

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
The Baruch Padeh Medical Center, Poriya

Outcome
Type Measure Description Time frame Safety issue
Primary Whole saliva & translocator protein (TSPO) Change in whole saliva & translocator protein (TSPO) post periodontal treatment Intake of patients than 8 - 12 weeks after periodontal treatment (scaling & root planning) No
Secondary Periodontal measurements (periodontal pocket depth, bleeding on probing & clinical attachment level) periodontal probing depth, bleeding on probing and clinical attachment level. Intake 8 - 12 weeks post periodontal treatment (scaling & root planning) No
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