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Periodontal Treatment and Glycemic Control

Primary Purpose

Diabetes Mellitus Type 2

Status
Unknown status
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Non Surgical Periodontal Treatment
Sponsored by
Pakistan Institute of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus Type 2

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pakistan Institute of Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Periodontal Treatment

Non treatment group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
Periodontal Pocket Depth
A change in Periodontal pocket will be measured in millimeters for the above mentioned time frame

Full Information

First Posted
June 12, 2013
Last Updated
July 15, 2013
Sponsor
Pakistan Institute of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01901926
Brief Title
Periodontal Treatment and Glycemic Control
Official Title
Impact of Non Surgical Periodontal Treatment on Glycemic Control in Type II Diabetics
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Unknown status
Study Start Date
December 2012 (undefined)
Primary Completion Date
September 2013 (Anticipated)
Study Completion Date
October 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pakistan Institute of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus Type 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
184 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Periodontal Treatment
Arm Type
Active Comparator
Arm Description
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
Arm Title
Non treatment group
Arm Type
No Intervention
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Non Surgical Periodontal Treatment
Intervention Description
one time intervention in the form of scaling and root planing
Primary Outcome Measure Information:
Title
Change in HbA1C levels from base line at 3, 6 and 9 months
Description
HbA1C levels will be recorded and any change in percentage noted
Time Frame
3 months, 6 months, 9 months
Secondary Outcome Measure Information:
Title
Bleeding on Probing
Description
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
Time Frame
Base Line, 3 months, 6 months and 9 months
Title
Clinical Attachment Loss
Description
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
Time Frame
Base Line, 3 months, 6 months, 9 months
Title
Periodontal Pocket Depth
Description
A change in Periodontal pocket will be measured in millimeters for the above mentioned time frame
Time Frame
Base Line, 3 months, 6 months, 9 months
Other Pre-specified Outcome Measures:
Title
Fasting Blood Glucose
Time Frame
Base Line, 3, 6 and 9 Months
Title
C-Reactive Protein
Time Frame
Base Line, 3 months, 6 months, 9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Salman Aziz, FCPS, MFDS
Organizational Affiliation
Pakistan Institute of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pakistan Institute of Medical Sciences
City
Islamabad
State/Province
Federal Capital
ZIP/Postal Code
54000
Country
Pakistan

12. IPD Sharing Statement

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Periodontal Treatment and Glycemic Control

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