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Completed Phase 3 Interventional

Diabetes and Periodontal Therapy Trial

ClinicalTrials.gov ID: NCT00997178

Public ClinicalTrials.gov record NCT00997178. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 5, 2026, 5:33 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Multicenter Randomized Single-Masked Clinical Trial Testing the Effect of Non-surgical Periodontal Therapy on Glycosylated Hemoglobin (HbA1c) Levels in Subjects With Type 2 Diabetes and Chronic Periodontitis

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The primary aim of the study is to determine if non-surgical periodontal therapy (scaling and root planing and supportive periodontal therapy) is efficacious compared to delayed therapy in reducing elevated glycosylated hemoglobin (HbA1c) at 6 months post-randomization in subjects with type 2 diabetes and untreated, moderate to advanced chronic periodontitis. The secondary aims of the study are to: 1. evaluate whether 6 month (or shorter-term (3 month)) changes in clinical measures of chronic periodontitis (gingival index, bleeding on probing, probing depth, clinical attachment level) are related to changes in HbA1c and fasting glucose or insulin resistance as measured by the Homeostasis Model Assessment 2 (HOMA2). 2. assess the 3 month and 6 month efficacy of periodontal therapy on all of the above study outcomes. If a treatment response is observed for any of the study outcomes at 3 months, then the trial can evaluate whether this response is sustained at 6 months.

Study identification

NCT ID
NCT00997178
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Stony Brook University
Other
Enrollment
514 participants

Conditions and interventions

Eligibility (public fields only)

Age range
35 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Sep 30, 2009
Primary completion
Sep 30, 2012
Completion
Nov 30, 2012
Last update posted
Jan 19, 2014

2009 – 2012

United States locations

U.S. sites
8
U.S. states
4
U.S. cities
5
Facility City State ZIP Site status
Clinical Site: University of Alabama at Birmingham Birmingham Alabama 35294
Clinical Site: University of Minnesota Minneapolis Minnesota 55455
Core Laboratory: University of Minnesota Minneapolis Minnesota 55455
Coordinating Center: Stony Brook University- Stony Brook New York 11794-8036
Administrative Center/Study Chair's Office: Stony Brook University Stony Brook New York 11794
Clinical Site: Stony Brook University Stony Brook New York 11794
University of Texas, Health Sciences Center at Houston Houston Texas 77030
Clinical Site: University of Texas Health Science Center San Antonio Texas 78229

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00997178, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jan 19, 2014 · Synced Sep 5, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00997178 live on ClinicalTrials.gov.

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