Periodontal Treatment and Glycemic Control

Not Applicable

• Conditions: Diabetes Mellitus Type 2
• Interventions: Procedure: Non Surgical Periodontal Treatment

• Registration Number: NCT01901926
• Lead Sponsor: Pakistan Institute of Medical Sciences

Brief Summary

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

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 Timeline

• Study Start: 2012-12
• Study First Submitted: 2013-06-12
• Status Verified: 2013-07
• Study First Submitted QC: 2013-07-15
• Last Update Submitted: 2013-07-15
• Study First Posted: 2013-07-17
• Last Update Posted: 2013-07-17
• Primary Completion: 2013-09
• Study Completion: 2013-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 184

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Periodontal Treatment	Non Surgical 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

Primary Outcome Measures

Name	Time	Method
Change in HbA1C levels from base line at 3, 6 and 9 months	3 months, 6 months, 9 months	HbA1C levels will be recorded and any change in percentage noted

Secondary Outcome Measures

Name	Time	Method
Bleeding on Probing	Base Line, 3 months, 6 months and 9 months	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
Clinical Attachment Loss	Base Line, 3 months, 6 months, 9 months	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
Periodontal Pocket Depth	Base Line, 3 months, 6 months, 9 months	A change in Periodontal pocket will be measured in millimeters for the above mentioned time frame

Trial Locations

Locations (1)

Pakistan Institute of Medical Sciences; 🇵🇰 Islamabad, Federal Capital, Pakistan