NCT05587413

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
112

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 12, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 20, 2022

Completed
13 days until next milestone

Study Start

First participant enrolled

November 2, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2022

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

November 2, 2022

Status Verified

November 1, 2022

Enrollment Period

2 months

First QC Date

October 12, 2022

Last Update Submit

November 1, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change of HbA1C between the control group and interventional group.

    The primary outcome of the trial

    one year

Study Arms (2)

treatment group

EXPERIMENTAL
Procedure: periodontal care

control group

NO INTERVENTION

Interventions

periodontal treatment

treatment group

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uol

Lahore, Punjab Province, Pakistan

RECRUITING

MeSH Terms

Conditions

Patient Compliance

Condition Hierarchy (Ancestors)

Patient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Central Study Contacts

gul muhammad shaikh, bds

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

October 12, 2022

First Posted

October 20, 2022

Study Start

November 2, 2022

Primary Completion

December 20, 2022

Study Completion

December 30, 2022

Last Updated

November 2, 2022

Record last verified: 2022-11

Locations