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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01595594
First Posted: May 10, 2012
Last Update Posted: July 16, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
Arthur Belem Novaes Jr, University of Sao Paulo
  Purpose
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 Intervention Phase
Periodontal Disease Type 2 Diabetes Drug: Systemic Doxycycline and Sham aPDT Drug: aPDT + Doxycycline Placebo Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Arthur Belem Novaes Jr, University of Sao Paulo:

Primary Outcome Measures:
  • Clinical Attachment Level [ Time Frame: 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:
  • Microbial Load [ Time Frame: 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.


Enrollment: 30
Study Start Date: March 2010
Study Completion Date: October 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01595594


Locations
Brazil
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
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Arthur Belem Novaes Jr, Chairman, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01595594     History of Changes
Other Study ID Numbers: FAPESP
First Submitted: August 15, 2011
First Posted: May 10, 2012
Last Update Posted: July 16, 2014
Last Verified: July 2014

Keywords provided by Arthur Belem Novaes Jr, University of Sao Paulo:
Periodontal Diseases
Type 2 Diabetes Mellitus
hemoglobin A1c protein

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Periodontal Diseases
Gingival Diseases
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Mouth Diseases
Stomatognathic Diseases
Doxycycline
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents