Antimicrobial Photodynamic Therapy on Periodontal Treatment and Salivary Status of Type 1 Diabetes Mellitus Patients
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|ClinicalTrials.gov Identifier: NCT03102892|
Recruitment Status : Recruiting
First Posted : April 6, 2017
Last Update Posted : April 6, 2017
|Condition or disease||Intervention/treatment|
|Diabetes Mellitus, Type 1 Periodontal Diseases Periodontal Pocket||Procedure: Scaling root planing Procedure: Antimicrobial photodynamic therapy|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Adjuvant Effect of Antimicrobial Photodynamic Therapy on Periodontal Treatment and Salivary Status of Type 1 Diabetes Mellitus Patients|
|Actual Study Start Date :||March 10, 2017|
|Estimated Primary Completion Date :||October 10, 2018|
|Estimated Study Completion Date :||December 10, 2018|
Active Comparator: Scaling Root Planing
Treatment by scaling and root planing. Repetition after 7 and 14 days.
Procedure: Scaling root planing
Treatment by scaling and root planing alone.
Experimental: Antimicrobial Photodynamic Therapy
Scaling and root planing and Antimicrobial photodynamic therapy with red laser (658 nm, 0.1 Watts, 2229 J/cm², 10s per point) and methylene blue dye (10mg/ml). Repetition after 7 and 14 days.
Procedure: Scaling root planing
Treatment by scaling and root planing alone.Procedure: Antimicrobial photodynamic therapy
Treatment with methylene blue dye and red laser
- Periodontal disease (gingivitis and periodontitis) measured by a periodontal probe and classified according to severity [ Time Frame: 6 months ]Severe periodontitis was defined by the presence of ≥ 2 interproximal sites in different teeth with clinical attachment level (CAL) ≥ 6mm and ≥1 interproximal site with periodontal probing depth (PPD) ≥5mm. Moderate periodontitis was defined by the presence of ≥ 2 interproximal sites in different teeth with CAL ≥ 4mm or ≥ 2 interproximal sites in different teeth with PPD ≥5mm. Mild periodontitis was defined as ≥ 2 interproximal sites in different teeth with ≥ 3 mm CAL and ≥ 2 interproximal sites in different teeth with ≥ 4 mm PPD or at least 1 site with PPD ≥ 5 mm (20,21). Gingivitis was determined as follows: Subjects were considered healthy if presented PPD ≤3mm/Bleeding on probing (BOP) extent scores < 10% and with gingivitis if presented PPD ≤3mm/ BOP extent scores >10%.
- Salivary glucose - collection of stimulated saliva in 10 minutes and measured with a colorimetric kit [ Time Frame: 6 months ]Salivary glucose is measured by a colorimetric kit and the values are converted and presented as mg/dL. There are no reference value for this measurement. The analysis is done by means of correlation to blood glucose levels in mg/dL.
- Salivary pH and buffering Capacity - collection of stimulated saliva in 10 minutes and measurement of acidity with a pHmeter [ Time Frame: 6 months ]Normal Salivary pH = 6 to 7. Buffering capacity: ≥ 5.6 were considered as ''high'', ranging from 4.1 to 5.5 were labelled as ''medium'' and those ≤4 were defined as ''low''.
- Capillary glycemia measured by a glucometer [ Time Frame: 6 months ]Normal glycemia: <100mg/dL
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): NCT03102892
|Contact: Carla Damante, PhD||55 14 firstname.lastname@example.org|
|Bauru School of Dentistry||Recruiting|
|Bauru, Sao Paulo, Brazil, 17012-901|
|Contact: Carla Damante, PhD 55 14 32358278 email@example.com|