| Trial ID: | L1803 |
| Source ID: | NCT03343366
|
| Associated Drug: |
Metronidazole
|
| Title: |
Glycemic Control in T2DM Through Non-Surgical Periodontal Therapy
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Chronic Periodontitis|Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: Metronidazole|PROCEDURE: Scaling Root Planing|BEHAVIORAL: Oral Hygiene Instructions
|
| Outcome Measures: |
Primary: Glycated Hemoglobin (HbA1c), To examine effects of three non-surgical periodontal therapies through change in HbA1c levels, Change from baseline (0) to 3 months and 6 months post intervention | Secondary: Clinical Periodontal Measure 1, To examine the changes in clinical periodontal measures in terms of Clinical Attachment Loss(CAL), Change at 1 and 3 months post intervention in all three groups|Clinical Periodontal Measure 2, To examine the changes in clinical periodontal measures in terms of Periodontal Pocket Depth (PPD), Change at 1 and 3 months post intervention in all three groups|Clinical Periodontal Measure 3, To examine the changes in clinical periodontal measures in terms of probing (BOP), Change at 1 and 3 months post intervention in all three groups|Fasting Blood Glucose (FBG), To identify an association of clinical periodontal changes on FBG, at 3 and 6 month follow-up between groups.|Fasting Plasma Insulin (FPI) levels, To identify an association of clinical periodontal changes on FPI, at 3 and 6 month follow-up between groups.|HOMA-IR, To identify an association of clinical periodontal changes on insulin resistance, at 3 and 6 month follow-up between groups.
|
| Sponsor/Collaborators: |
Sponsor: Dow University of Health Sciences | Collaborators: Higher Education Commission (Pakistan)
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2|PHASE3
|
| Enrollment: |
150
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (INVESTIGATOR)|Primary Purpose: PREVENTION
|
| Start Date: |
2018-01-01
|
| Completion Date: |
2020-07-30
|
| Results First Posted: |
|
| Last Update Posted: |
2020-08-21
|
| Locations: |
Dow University of Health Sciences, Karachi, Sind, 00000, Pakistan
|
| URL: |
https://clinicaltrials.gov/show/NCT03343366
|
