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

U

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

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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