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

• Sponsor: University of Lahore (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05587413
• Collaborator: (none)
• Enrollment: 112
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 1.9
• Patients Per Site Per Month: 58.8

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Patient Compliance	Procedure: periodontal care	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 112 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Single (Investigator)
• Primary Purpose: Health Services Research
• Official Title: Effectiveness of Periodontal Treatment for the Glycemic Conttrol of Type II Diabetes Mellitus
• Anticipated Study Start Date: Nov 2, 2022
• Anticipated Primary Completion Date: Dec 20, 2022
• Anticipated Study Completion Date: Dec 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: treatment group	Procedure: periodontal care; periodontal treatment
No Intervention: control group

Outcome Measures

Primary Outcome Measures

1. Change of HbA1C between the control group and interventional group. [one year]

   The primary outcome of the trial

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Uol	Lahore	Punjab	Pakistan

Sponsors and Collaborators

• University of Lahore

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Gul Muhammad Shaikh, Doctor, University of Lahore
• ClinicalTrials.gov Identifier: NCT05587413
• Other Study ID Numbers: UIPH/UOL/193/2019
• First Posted: Oct 20, 2022
• Last Update Posted: Nov 2, 2022
• Last Verified: Nov 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Nov 2, 2022