Effects of Adjunct Antimicrobial Photodynamic Therapy in Periodontal Treatment of Patients With Obesity

Study Overview
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Brief Summary
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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.

Official Title
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Effects of Antimicrobial Photodynamic Therapy in Non-surgical Periodontal Treatment of Patients With Obesity

Conditions
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Periodontitis, Obesity

Intervention / Treatment
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* Procedure: antimicrobial photodynamic therapy (aPDT)
* Procedure: Control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 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 |
| --- | --- |
| Experimental: Antimicrobial Photodynamic therapy adjunct to scaling and root planing<br>Treatment of scaling and root planing followed by antimicrobial photodynamic therapy with methylene blue (100 micrograms/ml) and red laser | Procedure: antimicrobial photodynamic therapy (aPDT)<br>* Scaling and root planing followed by antimicrobial photodynamic therapy<br>* Other names: Photochemotherapy;|
| Active Comparator: Control<br>Treatment of scaling and root planing. | Procedure: Control<br>* Treatment of scaling and root planing<br>* Other names: scaling and root planing;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline, 1,3,and 6 months | 
| 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. | baseline, 3 and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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periodontitis, obesity