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

This study has been completed.
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
Arthur Belem Novaes Jr, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01595594
First received: August 15, 2011
Last updated: July 15, 2014
Last verified: July 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 University of Sao Paulo:

Primary Outcome Measures:
  • Clinical Attachment Level [ Time Frame: 0, 1 month, 3 months and 6 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   35 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
Responsible Party: Arthur Belem Novaes Jr, Chairman, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01595594     History of Changes
Other Study ID Numbers: FAPESP
Study First Received: August 15, 2011
Last Updated: July 15, 2014
Health Authority: Brazil: Ethics Committee

Keywords provided by University of Sao Paulo:
Periodontal Diseases
Type 2 Diabetes Mellitus
hemoglobin A1c protein

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

ClinicalTrials.gov processed this record on October 19, 2014