Periodontal Treatment and Glycemic Control
Impact of Non Surgical Periodontal Treatment on Glycemic Control in Type II Diabetics
1 other identifier
interventional
184
1 country
1
Brief Summary
The purpose of this study is to determine the effects of non surgical periodontal treatment on glycemic control in type II diabetics.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable diabetes-mellitus-type-2
Started Dec 2012
Shorter than P25 for not_applicable diabetes-mellitus-type-2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2012
CompletedFirst Submitted
Initial submission to the registry
June 12, 2013
CompletedFirst Posted
Study publicly available on registry
July 17, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2013
CompletedJuly 17, 2013
July 1, 2013
9 months
June 12, 2013
July 15, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Bleeding on Probing
Base Line, 3 months, 6 months and 9 months
Clinical Attachment Loss
Base Line, 3 months, 6 months, 9 months
Periodontal Pocket Depth
Base Line, 3 months, 6 months, 9 months
Other Outcomes (2)
Fasting Blood Glucose
Base Line, 3, 6 and 9 Months
C-Reactive Protein
Base Line, 3 months, 6 months, 9 months
Study Arms (2)
Periodontal Treatment
ACTIVE COMPARATORPeriodontal 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
Non treatment group
NO INTERVENTIONthis 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
Interventions
one time intervention in the form of scaling and root planing
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Pakistan Institute of Medical Sciences
Islamabad, Federal Capital, 54000, Pakistan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Salman Aziz, FCPS, MFDS
Pakistan Institute of Medical Sciences
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Senior Post Graduate Resident (Dentistry)
Study Record Dates
First Submitted
June 12, 2013
First Posted
July 17, 2013
Study Start
December 1, 2012
Primary Completion
September 1, 2013
Study Completion
October 1, 2013
Last Updated
July 17, 2013
Record last verified: 2013-07