Periodontal Treatment and Glycemic Control

Impact of Non Surgical Periodontal Treatment on Glycemic Control in Type II Diabetics

The purpose of this study is to determine the effects of non surgical periodontal treatment on glycemic control in type II diabetics.

Study Overview

• Status: Unknown
• Conditions: Diabetes Mellitus Type 2
• Intervention / Treatment: Procedure: Non Surgical Periodontal Treatment

Detailed Description

The selected patients in treatment group will be given mechanical periodontal treatment in the form of scaling and root planning while the non intervention group patients will not receive treatment until the end of the trial.

• Study Type: Interventional
• Enrollment (Actual): 184
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Federal Capital
    • Islamabad, Federal Capital, Pakistan, 54000
      • Pakistan Institute of Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Diagnosed patients of Type 2 Diabetes Mellitus for at least 2 years
• HbA1C values >6.5 % as per ADA criteria
• non smokers
• Patients with at least 16 standing teeth
• At least 8 teeth with one site having Mild to Moderate periodontal disease

Exclusion Criteria:

• Smokers
• Type 2 Diabetics with complications e.g. renal, ophthalmic etc
• Patients with chronic infections
• Patients who get hospitalized or have to change their medications during the course of study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Periodontal Treatment; Periodontal Treatment in the form of Full mouth scaling and root planning will be given at one time only i.e. at baseline after full mouth dental checkup. Checkup will be repeated at 3, 6 & 9 month interval along with HbA1C levels	Procedure: Non Surgical Periodontal Treatment; one time intervention in the form of scaling and root planing
No Intervention: Non treatment group; this group will only receive detailed dental check ups at the specified time 0, 3, 6 and 9 months respectively and there will be no scaling done. HbA1C levels will be estimated at the above specified times

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in HbA1C levels from base line at 3, 6 and 9 months	HbA1C levels will be recorded and any change in percentage noted	3 months, 6 months, 9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bleeding on Probing	a change in the above mentioned periodontal parameters will be recorded at the specified times Bleeding on probing will be recorded as Yes or No for each tooth	Base Line, 3 months, 6 months and 9 months
Clinical Attachment Loss	A change in the above mentioned periodontal parameter will be recorded at the specified times Clinical Attachment loss will be recorded in millimeters for each tooth	Base Line, 3 months, 6 months, 9 months
Periodontal Pocket Depth	A change in Periodontal pocket will be measured in millimeters for the above mentioned time frame	Base Line, 3 months, 6 months, 9 months

Other Outcome Measures

Outcome Measure	Time Frame
Fasting Blood Glucose	Base Line, 3, 6 and 9 Months
C-Reactive Protein	Base Line, 3 months, 6 months, 9 months

Collaborators and Investigators

• Sponsor: Pakistan Institute of Medical Sciences
• Investigators: Principal Investigator: Salman Aziz, FCPS, MFDS, Pakistan Institute of Medical Sciences

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Anticipated): September 1, 2013
• Study Completion (Anticipated): October 1, 2013

Study Registration Dates

• First Submitted: June 12, 2013
• First Submitted That Met QC Criteria: July 15, 2013
• First Posted (Estimate): July 17, 2013

Study Record Updates

• Last Update Posted (Estimate): July 17, 2013
• Last Update Submitted That Met QC Criteria: July 15, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: Salman-0509