Comparison Between aPDT and Systemic Doxycycline on Non-surgical Periodontal Therapy in Type 2 Diabetics
Primary Purpose
Periodontal Disease, Type 2 Diabetes
Status
Completed
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Systemic Doxycycline and Sham aPDT
aPDT + Doxycycline Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Periodontal Disease focused on measuring Periodontal Diseases, Type 2 Diabetes Mellitus, hemoglobin A1c protein
Eligibility 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
Sites / Locations
- Faculdade de Odontologia de Ribeirão Preto
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Systemic Doxycycline
aPDT+ Placebo
Arm Description
Outcomes
Primary Outcome Measures
Clinical Attachment Level
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
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.
Full Information
NCT ID
NCT01595594
First Posted
August 15, 2011
Last Updated
July 15, 2014
Sponsor
University of Sao Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
1. Study Identification
Unique Protocol Identification Number
NCT01595594
Brief Title
Comparison Between aPDT and Systemic Doxycycline on Non-surgical Periodontal Therapy in Type 2 Diabetics
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 Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
October 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontal Disease, Type 2 Diabetes
Keywords
Periodontal Diseases, Type 2 Diabetes Mellitus, hemoglobin A1c protein
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Systemic Doxycycline
Arm Type
Active Comparator
Arm Title
aPDT+ Placebo
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Systemic Doxycycline and Sham aPDT
Other Intervention Name(s)
aPDT Sham
Intervention Description
It will be prescribed a protocol of 100mg/day of Systemic Doxycycline for 14 days
Intervention Type
Drug
Intervention Name(s)
aPDT + Doxycycline Placebo
Intervention Description
The aPDT protocol will consist in 5 applications on the experimental time 0, 1, 5, 7 and 14 days.
Primary Outcome Measure Information:
Title
Clinical Attachment Level
Description
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.
Time Frame
0, 1 month, 3 months and 6 months
Secondary Outcome Measure Information:
Title
Microbial Load
Description
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.
Time Frame
0, 3 months and 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Faculdade de Odontologia de Ribeirão Preto
City
Ribeirão Preto
State/Province
São Paulo
ZIP/Postal Code
14040-904
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
18454655
Citation
O'Connell PA, Taba M, Nomizo A, Foss Freitas MC, Suaid FA, Uyemura SA, Trevisan GL, Novaes AB, Souza SL, Palioto DB, Grisi MF. Effects of periodontal therapy on glycemic control and inflammatory markers. J Periodontol. 2008 May;79(5):774-83. doi: 10.1902/jop.2008.070250.
Results Reference
result
PubMed Identifier
19563331
Citation
Lulic M, Leiggener Gorog I, Salvi GE, Ramseier CA, Mattheos N, Lang NP. One-year outcomes of repeated adjunctive photodynamic therapy during periodontal maintenance: a proof-of-principle randomized-controlled clinical trial. J Clin Periodontol. 2009 Aug;36(8):661-6. doi: 10.1111/j.1600-051X.2009.01432.x. Epub 2009 Jun 25.
Results Reference
result
PubMed Identifier
26710892
Citation
Ramos UD, Ayub LG, Reino DM, Grisi MF, Taba M Jr, Souza SL, Palioto DB, Novaes AB Jr. Antimicrobial photodynamic therapy as an alternative to systemic antibiotics: results from a double-blind, randomized, placebo-controlled, clinical study on type 2 diabetics. J Clin Periodontol. 2016 Feb;43(2):147-55. doi: 10.1111/jcpe.12498. Epub 2016 Feb 19.
Results Reference
derived
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Comparison Between aPDT and Systemic Doxycycline on Non-surgical Periodontal Therapy in Type 2 Diabetics
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