Comparison Between aPDT and Systemic Doxycycline on Non-surgical Periodontal Therapy in Type 2 Diabetics

University of Sao Paulo

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes; Periodontal Disease

Treatments: Drug: aPDT + Doxycycline Placebo; Drug: Systemic Doxycycline and Sham aPDT

Study type: Interventional

Funder types: Other

Identifiers

NCT01595594

FAPESP (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 35 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Poorly Controlled Type 2 Diabetes (HbA1c > 7%)
• Advanced Chronic Periodontitis
• Presence of 15 teeth

Exclusion criteria

• Use on antiinflammatory drugs
• Use of antibiotics less then 6 months before therapy
• Smokers
• Positive for HIV
• Periodontal treatment less then 6 months before therapy
• Advanced complications of Diabetes

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups

Systemic Doxycycline

Active Comparator group

Treatment:

Drug: Systemic Doxycycline and Sham aPDT

aPDT+ Placebo

Experimental group

Treatment:

Drug: aPDT + Doxycycline Placebo