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

NCT01255254 | Unknown Phase 1

• 1 other identifier: RMB 0350-10 CTIL
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Gingival Scaling; Metabolic Control

Keywords

he effect of gingival scaling on Metabolic control

Outcome Measures

Primary Outcomes (1)

• Metabolic control

  Blood sample that measures fasting plasma glucose and the HbA1c level.

  3 months

Secondary Outcomes (1)

• Inflammation

  3 months

Study Arms (2)

A: Scaling group

EXPERIMENTAL

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

B: Control group

NO INTERVENTION

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.

Interventions

Gingival scaling PROCEDURE

Oral hygeine instruction and gingival scaling using hand and ultrsonic instruments.

A: Scaling group

Eligibility Criteria

• Age: 25 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 25- 75 years;
• Type 2 diabetes;
• Chronic periodontitis with 2 or more teeth with CAL≥6mm and one site with a PD≥5mm ("established periodontitis")16

You may not qualify if:

• Periodontal treatment within the last 3 months
• The use of antibiotics within the last 4 weeks
• Pregnancy or the intention to be pregnant in the next 4 months

Sponsors & Collaborators

• Rambam Health Care Campus: lead

Study Sites (1)

Department of Periodontology, School of Graduate Dentistry Rambam Health care campus

Haifa, Israel

RECRUITING

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 6, 2010
• First Posted: December 7, 2010
• Study Start: August 1, 2010
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: December 7, 2010

Record last verified: 2010-08

Locations

IL (1)