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

• Sponsor: Rambam Health Care Campus (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01255254
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Duration (Months): 12
• Patients Per Site Per Month: 3.3

Study Details

Study Description

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

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Study Start Date: Aug 1, 2010
• Anticipated Primary Completion Date: Aug 1, 2011
• Anticipated Study Completion Date: Aug 1, 2011

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Metabolic control [3 months]

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

Secondary Outcome Measures

1. Inflammation [3 months]

   Blood sample to measure C reactive protein (inflammatory marker).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 25 Years to 75 Years
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Periodontology, School of Graduate Dentistry Rambam Health care campus	Haifa		Israel

Sponsors and Collaborators

• Rambam Health Care Campus

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01255254
• Other Study ID Numbers: RMB 0350-10 CTIL
• First Posted: Dec 7, 2010
• Last Update Posted: Dec 7, 2010
• Last Verified: Aug 1, 2010

• Keywords provided by , ,: he effect of gingival scaling on Metabolic control

Study Results

No Results Posted as of Dec 7, 2010