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

November 1, 2022 updated by: Gul Muhammad Shaikh, University of Lahore
The project is intended to find out the effect of Periodontal treatment for the glycemic control of type II diabetes mellitus patients.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

112

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan
        • Recruiting
        • UOL
        • Contact:
          • gul

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: control group
EXPERIMENTAL: treatment group
Procedure: periodontal care
periodontal treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of HbA1C between the control group and interventional group.
Time Frame: one year
The primary outcome of the trial
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Lahore

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

November 2, 2022

Primary Completion (ANTICIPATED)

December 20, 2022

Study Completion (ANTICIPATED)

December 30, 2022

Study Registration Dates

First Submitted

October 12, 2022

First Submitted That Met QC Criteria

October 19, 2022

First Posted (ACTUAL)

October 20, 2022

Study Record Updates

Last Update Posted (ACTUAL)

November 2, 2022

Last Update Submitted That Met QC Criteria

November 1, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UIPH/UOL/193/2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

will be informed

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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