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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01255254
Other study ID # RMB 0350-10 CTIL
Secondary ID
Status Recruiting
Phase Phase 1
First received December 6, 2010
Last updated December 6, 2010
Start date August 2010
Est. completion date August 2011

Study information

Verified date August 2010
Source Rambam Health Care Campus
Contact n/a
Is FDA regulated No
Health authority Israel: IRB
Study type Interventional

Clinical Trial Summary

The aim of the study is to evaluate the effect of non-surgical periodontal therapy, consisting of oral hygiene instruction, full mouth scaling and an antimicrobial rinse on the metabolic control of chronic periodontitis patients with type II diabetes mellitus.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date August 2011
Est. primary completion date August 2011
Accepts healthy volunteers No
Gender Both
Age group 25 Years to 75 Years
Eligibility Inclusion Criteria:

1. Age 25- 75 years;

2. Type 2 diabetes;

3. Chronic periodontitis with 2 or more teeth with CAL=6mm and one site with a PD=5mm ("established periodontitis")16

Exclusion Criteria:

1. Periodontal treatment within the last 3 months

2. The use of antibiotics within the last 4 weeks

3. Pregnancy or the intention to be pregnant in the next 4 months

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
Gingival scaling
Oral hygeine instruction and gingival scaling using hand and ultrsonic instruments.

Locations

Country Name City State
Israel Department of Periodontology, School of Graduate Dentistry Rambam Health care campus Haifa

Sponsors (1)

Lead Sponsor Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary Metabolic control Blood sample that measures fasting plasma glucose and the HbA1c level. 3 months No
Secondary Inflammation Blood sample to measure C reactive protein (inflammatory marker). 3 months No
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