Effects of Adjunct Antimicrobial Photodynamic Therapy in Periodontal Treatment of Patients With Obesity
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorUniversity of Sao Paulo
About this trial
The goal of this clinical trial is to compare the effects of adjuvant antimicrobial photodynamic therapy (aPDT) as an adjuvant of scaling and root planing with scaling and root planing alone for periodontal treatment in patients with periodontal disease and obesity. The main question it aims to answer are: Does adjuvant aPDT improves periodontal health? Are there differences in the proteomic profile of gingival fluid after both treatments? Participants will receive scaling and root planing complemented or not by aPDT. Results will be collected after 1, 3, and 6 months. Researchers will compare adjuvant aPDT treatment to regular treatment to see if it promotes reduction in inflammation and improvement in periodontal health.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Obesity (grade II and III classified according to Body Mass Index)
Periodontitis stage II to IV
Presence of at least 20 teeth excluding 3rd molars.
Disqualifiers
Smokers
Alcohol or drugs consumption
Kidney disorders
Pregnancy or lactation
Trial design
Design model
Parallel
Treatments tested in this trial
antimicrobial photodynamic therapy (aPDT)
Procedure/SurgeryScaling and root planing followed by antimicrobial photodynamic therapy
Control
Procedure/SurgeryTreatment of scaling and root planing
Treatment groups
24 Participants
are divided into 2 treatment groupsGroup A: Antimicrobial Photodynamic therapy adjunct to scaling and root planingExperimental treatment 1 intervention
Group B: ControlActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Probing depth
Changes in probing depth measured from the gingival margin to the bottom of periodontal sulcus or periodontal pocket by a periodontal probe in millimeters.
Time frame
Baseline, 1, 3 and 6 months2
Clinical attachment level
Changes in clinical attachment level measured from the cemento-enamel junction to the bottom of periodontal sulcus or periodontal pocket by a periodontal probe in millimeters.
Time frame
Baseline, 1, 3 and 6 monthsSecondary outcomes
1
Changes on bleeding on probing
Changes in percentage of sites with bleeding after probing. Six sites per tooth are examined and presence/absence of bleeding is recorded.
Time frame
Baseline, 1,3,and 6 months2
Differences in proteomics
Changes in inflammatory proteins after treatment by proteomics assay. Presence or absence of proteins in gingival fluid are compared before and after treatment.
Time frame
baseline, 3 and 6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov