Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-26 @ 3:56 AM
Study NCT ID:
NCT01595594
Status:
COMPLETED
Last Update Posted:
2014-07-16
First Post:
2011-08-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison Between aPDT and Systemic Doxycycline on Non-surgical Periodontal Therapy in Type 2 Diabetics
Sponsor:
University of Sao Paulo
Organization:
Study Overview
Official Title:
Effect of a PDT Protocol With Multiple Applications as an Adjuvant on the Non Surgical Treatment of Periodontal Disease in Patients With Type 2 Diabetes. A Clinical and Laboratorial Study in Humans
Status:
COMPLETED
Status Verified Date:
2014-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of this study is to evaluate Photodynamic Therapy (PDT) as adjunct on non surgical periodontal therapy in patients with type 2 diabetes. A total of 40 individuals will be selected and divided in two groups. On the treatment stage, the control group (Group C) will receive standard non surgical periodontal treatment. The Test Group (Group T) will be treated with PDT as an adjunct to non surgical periodontal treatment. The treatment will be repeated 4 times in two weeks, followed by dental prophylaxis every 15 days until accomplish 3 months. The follow-up will be done for 6 months. The clinical parameters measured will be: plaque index, pocket depth, bleeding on probing, relative clinical insertion level and suppuration. In addition, the evaluation of crevicular fluid volume and the levels of IL-1, TNF-α, subgingival microbiota by the hybridization DNA-DNA Checkerboard technique. The investigators expect to find identical or better results for the test group.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: