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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Periodontal Disease, Type 2 Diabetes

Intervention / Treatment
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* Drug: Systemic Doxycycline and Sham aPDT
* Drug: aPDT + Doxycycline Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Systemic Doxycycline<br> | Drug: Systemic Doxycycline and Sham aPDT<br>* It will be prescribed a protocol of 100mg/day of Systemic Doxycycline for 14 days<br>* Other names: aPDT Sham;|
| Experimental: aPDT+ Placebo<br> | Drug: aPDT + Doxycycline Placebo<br>* The aPDT protocol will consist in 5 applications on the experimental time 0, 1, 5, 7 and 14 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 0, 1 month, 3 months and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 0, 3 months and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Periodontal Diseases, Type 2 Diabetes Mellitus, hemoglobin A1c protein