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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by Rambam Health Care Campus.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Rambam Health Care Campus
ClinicalTrials.gov Identifier:
NCT01255254
First received: December 6, 2010
Last updated: NA
Last verified: August 2010
History: No changes posted
  Purpose

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 Intervention Phase
Gingival Scaling
Metabolic Control
Procedure: Gingival scaling
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Rambam Health Care Campus:

Primary Outcome Measures:
  • Metabolic control [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Blood sample that measures fasting plasma glucose and the HbA1c level.


Secondary Outcome Measures:
  • Inflammation [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Blood sample to measure C reactive protein (inflammatory marker).


Estimated Enrollment: 40
Study Start Date: August 2010
Estimated Study Completion Date: August 2011
Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   25 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01255254

Locations
Israel
Department of Periodontology, School of Graduate Dentistry Rambam Health care campus Recruiting
Haifa, Israel
Contact: Dr. Rina Elmaleh, DMD    +97206470740    r_elmaleh@rambam.health.gov.il   
Sub-Investigator: Prof Eli Machtei, DMD         
Sponsors and Collaborators
Rambam Health Care Campus
  More Information

No publications provided

Responsible Party: Department of Periodontology, School of Gradute Dentistry Rambam Health care campus Haifa, Israel
ClinicalTrials.gov Identifier: NCT01255254     History of Changes
Other Study ID Numbers: RMB 0350-10 CTIL
Study First Received: December 6, 2010
Last Updated: December 6, 2010
Health Authority: Israel: IRB

Keywords provided by Rambam Health Care Campus:
he effect of gingival scaling on Metabolic control

ClinicalTrials.gov processed this record on August 19, 2014