Comparison Between aPDT and Systemic Doxycycline on Non-surgical Periodontal Therapy in Type 2 Diabetics
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|ClinicalTrials.gov Identifier: NCT01595594|
Recruitment Status : Completed
First Posted : May 10, 2012
Last Update Posted : July 16, 2014
|Condition or disease||Intervention/treatment||Phase|
|Periodontal Disease Type 2 Diabetes||Drug: Systemic Doxycycline and Sham aPDT Drug: aPDT + Doxycycline Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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 Start Date :||March 2010|
|Primary Completion Date :||April 2012|
|Study Completion Date :||October 2012|
|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.
- 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.
- 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.
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
|Faculdade de Odontologia de Ribeirão Preto|
|Ribeirão Preto, São Paulo, Brazil, 14040-904|