The Effect of Oral Hygiene and Full Mouth Scaling on Metabolic Control in Patients With Type II Diabetes

Metabolic Control Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01255254
• Other study ID #: RMB 0350-10 CTIL
• 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

• Gingival Scaling
• Metabolic Control

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