Periodontal Treatment and Glycemic Control

Diabetes Mellitus Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01901926
• Other study ID #: Salman-0509
• Status: Active, not recruiting
• Phase: N/A
• First received: June 12, 2013
• Last updated: July 15, 2013
• Start date: December 2012
• Est. completion date: October 2013

Study information

• Verified date: July 2013
• Source: Pakistan Institute of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Pakistan: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 184
• Est. completion date: October 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus Type 2
• Diabetes Mellitus, Type 2

Intervention

Procedure:
• Non Surgical Periodontal Treatment
one time intervention in the form of scaling and root planing

Locations

Country	Name	City	State
Pakistan	Pakistan Institute of Medical Sciences	Islamabad	Federal Capital

Sponsors (1)

Lead Sponsor	Collaborator
Pakistan Institute of Medical Sciences

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Fasting Blood Glucose		Base Line, 3, 6 and 9 Months	No
Other	C-Reactive Protein		Base Line, 3 months, 6 months, 9 months	No
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No