Periodontitis, Obesity
Conditions
Keywords
periodontitis, obesity
Brief summary
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.
Interventions
Scaling and root planing followed by antimicrobial photodynamic therapy
PROCEDUREControl
Treatment of scaling and root planing
Sponsors
University of Sao Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Participants will be masked using a sham laser. Outcomes assessor will be blinded in relation to naming of the experimental groups.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* Smokers * Alcohol or drugs consumption * Kidney disorders * Pregnancy or lactation * Use of antibiotics at the last 30 days * Use of drugs that alter periodontal structures as phenytoin or ciclosporin * Periodontal treatment at the last 6 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Probing depth | Baseline, 1, 3 and 6 months | Changes in probing depth measured from the gingival margin to the bottom of periodontal sulcus or periodontal pocket by a periodontal probe in millimeters. |
| Clinical attachment level | Baseline, 1, 3 and 6 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes on bleeding on probing | Baseline, 1,3,and 6 months | Changes in percentage of sites with bleeding after probing. Six sites per tooth are examined and presence/absence of bleeding is recorded. |
| Differences in proteomics | baseline, 3 and 6 months | Changes in inflammatory proteins after treatment by proteomics assay. Presence or absence of proteins in gingival fluid are compared before and after treatment. |
Countries
Brazil
Outcome results
None listed