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

Sponsor
University of Sao Paulo (Other)
Overall Status
Completed
CT.gov ID
NCT01595594
Collaborator
Fundação de Amparo à Pesquisa do Estado de São Paulo (Other)
30
Enrollment
1
Location
2
Arms
31
Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Systemic Doxycycline and Sham aPDT
  • Drug: aPDT + Doxycycline Placebo
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
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
Study Start Date :
Mar 1, 2010
Actual Primary Completion Date :
Apr 1, 2012
Actual Study Completion Date :
Oct 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Systemic Doxycycline

Drug: Systemic Doxycycline and Sham aPDT
It will be prescribed a protocol of 100mg/day of Systemic Doxycycline for 14 days
Other Names:
  • aPDT Sham

    		•
    Experimental: aPDT+ Placebo

    Drug: aPDT + Doxycycline Placebo
    The aPDT protocol will consist in 5 applications on the experimental time 0, 1, 5, 7 and 14 days.

    Outcome Measures

    Primary Outcome Measures

    1. Clinical Attachment Level [0, 1 month, 3 months and 6 months]

      There will be analyzed the changes in clinical attachment level at the proposed experimental times. Clinical attatchment level is known as a proper outcome to evaluate periodontal disease progression or regression. It is measured as the distace between the deepet point fo the periodontal pocket and a stabilshed point, on the case of this study, the tooth occlusal surface.

    Secondary Outcome Measures

    1. Microbial Load [0, 3 months and 6 months]

      There will be mesaured the changes of microbial load at the proposed experimental times. Microbial load at deep pocket seems to change regarding periodontal treatment and it is expected a reduction after treatment. measuring on various experimental times it will be possible to evaluate treatment stability on reducing periodontopathogens.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    35 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Faculdade de Odontologia de Ribeirão Preto Ribeirão Preto São Paulo Brazil 14040-904

    Sponsors and Collaborators

    • University of Sao Paulo
    • Fundação de Amparo à Pesquisa do Estado de São Paulo

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Arthur Belem Novaes Jr, Chairman, University of Sao Paulo
    ClinicalTrials.gov Identifier:
    NCT01595594
    Other Study ID Numbers:
    • FAPESP
    First Posted:
    May 10, 2012
    Last Update Posted:
    Jul 16, 2014
    Last Verified:
    Jul 1, 2014
    Keywords provided by Arthur Belem Novaes Jr, Chairman, University of Sao Paulo
    Periodontal Diseases
    Type 2 Diabetes Mellitus
    hemoglobin A1c protein
    Additional relevant MeSH terms:
    Periodontal Diseases
    Diabetes Mellitus, Type 2
    Doxycycline

    Study Results

    No Results Posted as of Jul 16, 2014