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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01255254
Recruitment Status : Unknown
Verified August 2010 by Rambam Health Care Campus.
Recruitment status was:  Recruiting
First Posted : December 7, 2010
Last Update Posted : December 7, 2010
Information provided by:
Rambam Health Care Campus

Brief 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.

Condition or disease Intervention/treatment Phase
Gingival Scaling Metabolic Control Procedure: Gingival scaling Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Study Start Date : August 2010
Estimated Primary Completion Date : August 2011
Estimated Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dental Health

Arm Intervention/treatment
Experimental: A: Scaling group
The experimental group will receive oral hygiene instruction (OHI) and full-mouth scaling using standard rigid Gracey curettes (Hu-Friedy® Manufacturing Inc., Chicago, IL, USA) and ultrasonic instrumentation (EMS piezoelectric system, Electro Medical Systems, Nyon, Switzerland) at week 1-2 and at a second reinforcement visit at 6-8 weeks. Subjects will also be instructed to rinse with 10ml of Chlorhexidine 0.2% mouthrinse twice daily for 30 seconds for the duration of the study.
Procedure: Gingival scaling
Oral hygeine instruction and gingival scaling using hand and ultrsonic instruments.

No Intervention: B: Control group
The control group will receive no periodontal treatment during the study. After completion of the study, these patients will be given oral hygiene instruction and a full mouth scaling.

Primary Outcome Measures :
  1. Metabolic control [ Time Frame: 3 months ]
    Blood sample that measures fasting plasma glucose and the HbA1c level.

Secondary Outcome Measures :
  1. Inflammation [ Time Frame: 3 months ]
    Blood sample to measure C reactive protein (inflammatory marker).

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01255254

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Department of Periodontology, School of Graduate Dentistry Rambam Health care campus Recruiting
Haifa, Israel
Contact: Dr. Rina Elmaleh, DMD    +97206470740   
Sub-Investigator: Prof Eli Machtei, DMD         
Sponsors and Collaborators
Rambam Health Care Campus
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Responsible Party: Department of Periodontology, School of Gradute Dentistry Rambam Health care campus Haifa, Israel Identifier: NCT01255254    
Other Study ID Numbers: RMB 0350-10 CTIL
First Posted: December 7, 2010    Key Record Dates
Last Update Posted: December 7, 2010
Last Verified: August 2010
Keywords provided by Rambam Health Care Campus:
he effect of gingival scaling on Metabolic control