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

Phase 3

Completed

• Conditions: Periodontal Disease; Type 2 Diabetes
• Interventions: Drug: Systemic Doxycycline and Sham aPDT; Drug: aPDT + Doxycycline Placebo

• Registration Number: NCT01595594
• Lead Sponsor: University of Sao Paulo

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2011-08-15
• Primary Completion: 2012-04
• Study First Submitted QC: 2012-05-08
• Study First Posted: 2012-05-10
• Study Completion: 2012-10
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-15
• Last Update Posted: 2014-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Poorly Controlled Type 2 Diabetes (HbA1c > 7%)
• Advanced Chronic Periodontitis
• Presence of 15 teeth

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Systemic Doxycycline	Systemic Doxycycline and Sham aPDT	-
aPDT+ Placebo	aPDT + Doxycycline Placebo	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Faculdade de Odontologia de Ribeirão Preto; 🇧🇷 Ribeirão Preto, São Paulo, Brazil