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

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.

Study Overview

• Status: Unknown
• Conditions: Metabolic Control; Gingival Scaling
• Intervention / Treatment: Procedure: Gingival scaling

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 1

Contacts and Locations

Study Locations

• Israel
  • Haifa, Israel
    • Recruiting
    • Department of Periodontology, School of Graduate Dentistry Rambam Health care campus
    • Contact: Dr. Rina Elmaleh, DMD; Phone Number: +97206470740; Email: r_elmaleh@rambam.health.gov.il
    • Sub-Investigator: Prof Eli Machtei, DMD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Metabolic control	Blood sample that measures fasting plasma glucose and the HbA1c level.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inflammation	Blood sample to measure C reactive protein (inflammatory marker).	3 months

Collaborators and Investigators

• Sponsor: Rambam Health Care Campus

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (Anticipated): August 1, 2011
• Study Completion (Anticipated): August 1, 2011

Study Registration Dates

• First Submitted: December 6, 2010
• First Submitted That Met QC Criteria: December 6, 2010
• First Posted (Estimate): December 7, 2010

Study Record Updates

• Last Update Posted (Estimate): December 7, 2010
• Last Update Submitted That Met QC Criteria: December 6, 2010
• Last Verified: August 1, 2010

More Information

Terms related to this study

• Keywords: he effect of gingival scaling on Metabolic control
• Other Study ID Numbers: RMB 0350-10 CTIL