Trials / Completed
CompletedNCT01595594
Comparison Between aPDT and Systemic Doxycycline on Non-surgical Periodontal Therapy in Type 2 Diabetics
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
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- University of Sao Paulo · Academic / Other
- Sex
- All
- Age
- 35 Years – 70 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Systemic Doxycycline and Sham aPDT | It will be prescribed a protocol of 100mg/day of Systemic Doxycycline for 14 days |
| DRUG | aPDT + Doxycycline Placebo | The aPDT protocol will consist in 5 applications on the experimental time 0, 1, 5, 7 and 14 days. |
Timeline
- Start date
- 2010-03-01
- Primary completion
- 2012-04-01
- Completion
- 2012-10-01
- First posted
- 2012-05-10
- Last updated
- 2014-07-16
Locations
1 site across 1 country: Brazil
Source: ClinicalTrials.gov record NCT01595594. Inclusion in this directory is not an endorsement.