Effectiveness of Periodontal Treatment for the Glycemic C... | NCT05587413

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

NCT05587413

Sponsor

University of Lahore

Status

Unknown status

Last Update Posted

Nov 2, 2022Actual

Enrollment

112Estimated

Phase

Not Applicable

Conditions

Patient Compliance

Interventions

periodontal care

Countries

Pakistan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2, 2022Estimated

Primary Completion Date

Dec 20, 2022Estimated

Completion Date

Dec 30, 2022Estimated

First Submitted Date

Oct 12, 2022

First Submission Date that Met QC Criteria

Oct 19, 2022

First Posted Date

Oct 20, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 1, 2022

Last Update Posted Date

Nov 2, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

112Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
treatment group	Experimental		Procedure: periodontal care
control group	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
periodontal care	Procedure	periodontal treatment	treatment group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
gul muhammad shaikh, bds	Contact	923332663614		shaikhgul25@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Uol	Recruiting	Lahore	Punjab Province		Pakistan

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

will be informed

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010349	Patient Compliance

Ancestor Terms

ID	Term
D010342	Patient Acceptance of Health Care
D000074822	Treatment Adherence and Compliance
D015438	Health Behavior
D001519	Behavior

Browse Leaves

Not provided

Browse Branches

Not provided