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

Phase 1

• Conditions: Gingival Scaling; Metabolic Control
• Interventions: Procedure: Gingival scaling

• Registration Number: NCT01255254
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2010-08
• Study Start: 2010-08
• Study First Submitted: 2010-12-06
• Study First Submitted QC: 2010-12-06
• Last Update Submitted: 2010-12-06
• Study First Posted: 2010-12-07
• Last Update Posted: 2010-12-07
• Primary Completion: 2011-08
• Study Completion: 2011-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A: Scaling group	Gingival scaling	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.

Primary Outcome Measures

Name	Time	Method
Metabolic control	3 months	Blood sample that measures fasting plasma glucose and the HbA1c level.

Secondary Outcome Measures

Name	Time	Method
Inflammation	3 months	Blood sample to measure C reactive protein (inflammatory marker).

Trial Locations

Locations (1)

Department of Periodontology, School of Graduate Dentistry Rambam Health care campus; 🇮🇱 Haifa, Israel