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Effectiveness of Periodontal Treatment for the Glycemic Conttrol of Type II Diabetes Mellitus

Primary Purpose

Patient Compliance

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
periodontal care
Sponsored by
University of Lahore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Patient Compliance

Eligibility Criteria

30 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Patients having Diabetes Mellitus and diagnosed with Periodontitis for last six months.
  2. Aged between 30-60 years.
  3. Patients with HbA1C level 7-9.5%, measured within three months prior to present study.

Exclusion Criteria:

  1. Patients with acute oral infection
  2. Need for immediate tooth extractions
  3. Severe Hypertension (>180/110 mm Hg)
  4. Edentulous Patients
  5. Patients with Diabetic Nephropathy
  6. Patients with Diabetic Retinopathy

Sites / Locations

  • UolRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

treatment group

control group

Arm Description

Outcomes

Primary Outcome Measures

Change of HbA1C between the control group and interventional group.
The primary outcome of the trial

Secondary Outcome Measures

Full Information

First Posted
October 12, 2022
Last Updated
November 1, 2022
Sponsor
University of Lahore
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1. Study Identification

Unique Protocol Identification Number
NCT05587413
Brief Title
Effectiveness of Periodontal Treatment for the Glycemic Conttrol of Type II Diabetes Mellitus
Official Title
Effectiveness of Periodontal Treatment for the Glycemic Conttrol of Type II Diabetes Mellitus
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 2, 2022 (Anticipated)
Primary Completion Date
December 20, 2022 (Anticipated)
Study Completion Date
December 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Lahore

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The project is intended to find out the effect of Periodontal treatment for the glycemic control of type II diabetes mellitus patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patient Compliance

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
112 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
treatment group
Arm Type
Experimental
Arm Title
control group
Arm Type
No Intervention
Intervention Type
Procedure
Intervention Name(s)
periodontal care
Intervention Description
periodontal treatment
Primary Outcome Measure Information:
Title
Change of HbA1C between the control group and interventional group.
Description
The primary outcome of the trial
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients having Diabetes Mellitus and diagnosed with Periodontitis for last six months. Aged between 30-60 years. Patients with HbA1C level 7-9.5%, measured within three months prior to present study. Exclusion Criteria: Patients with acute oral infection Need for immediate tooth extractions Severe Hypertension (>180/110 mm Hg) Edentulous Patients Patients with Diabetic Nephropathy Patients with Diabetic Retinopathy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
gul muhammad shaikh, bds
Phone
923332663614
Email
shaikhgul25@gmail.com
Facility Information:
Facility Name
Uol
City
Lahore
State/Province
Punjab
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
gul

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
will be informed

Learn more about this trial

Effectiveness of Periodontal Treatment for the Glycemic Conttrol of Type II Diabetes Mellitus

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