The Effect of Oral Hygiene and Full Mouth Scaling on Metabolic Control in Patients With Type II Diabetes
Recruitment status was Recruiting
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 Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
- Metabolic control [ Time Frame: 3 months ] [ Designated as safety issue: No ]Blood sample that measures fasting plasma glucose and the HbA1c level.
- Inflammation [ Time Frame: 3 months ] [ Designated as safety issue: No ]Blood sample to measure C reactive protein (inflammatory marker).
|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)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01255254
|Department of Periodontology, School of Graduate Dentistry Rambam Health care campus||Recruiting|
|Contact: Dr. Rina Elmaleh, DMD +97206470740 firstname.lastname@example.org|
|Sub-Investigator: Prof Eli Machtei, DMD|