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

Primary Purpose

Periodontitis, Obesity

Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
antimicrobial photodynamic therapy (aPDT)
Control
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontitis focused on measuring periodontitis, obesity

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Bauru School of DentistryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Antimicrobial Photodynamic therapy adjunct to scaling and root planing

Control

Arm Description

Treatment of scaling and root planing followed by antimicrobial photodynamic therapy with methylene blue (100 micrograms/ml) and red laser

Treatment of scaling and root planing.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
September 25, 2023
Last Updated
October 9, 2023
Sponsor
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT06073704
Brief Title
Effects of Adjunct Antimicrobial Photodynamic Therapy in Periodontal Treatment of Patients With Obesity
Official Title
Effects of Antimicrobial Photodynamic Therapy in Non-surgical Periodontal Treatment of Patients With Obesity
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 9, 2023 (Anticipated)
Primary Completion Date
October 23, 2024 (Anticipated)
Study Completion Date
December 23, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis, Obesity
Keywords
periodontitis, obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
Participants will be masked using a sham laser. Outcomes assessor will be blinded in relation to naming of the experimental groups.
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Antimicrobial Photodynamic therapy adjunct to scaling and root planing
Arm Type
Experimental
Arm Description
Treatment of scaling and root planing followed by antimicrobial photodynamic therapy with methylene blue (100 micrograms/ml) and red laser
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Treatment of scaling and root planing.
Intervention Type
Procedure
Intervention Name(s)
antimicrobial photodynamic therapy (aPDT)
Other Intervention Name(s)
Photodynamic therapy, Photochemotherapy
Intervention Description
Scaling and root planing followed by antimicrobial photodynamic therapy
Intervention Type
Procedure
Intervention Name(s)
Control
Other Intervention Name(s)
scaling and root planing
Intervention Description
Treatment of scaling and root planing
Primary Outcome Measure Information:
Title
Probing depth
Description
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 months
Title
Clinical attachment level
Description
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 months
Secondary Outcome Measure Information:
Title
Changes on bleeding on probing
Description
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 months
Title
Differences in proteomics
Description
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 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Bauru School of Dentistry
City
Bauru
State/Province
São Paulo
ZIP/Postal Code
17012-901
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carla Damante, PhD
Phone
+55 14 32266064
Email
cdamante@usp.br
First Name & Middle Initial & Last Name & Degree
Andreia Pavani, PhD
Phone
+55 14 32358366
Email
a-deia@hotmail.com
First Name & Middle Initial & Last Name & Degree
Carla Damante, PhD
First Name & Middle Initial & Last Name & Degree
Andreia Pavani, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29111391
Citation
Vohra F, Akram Z, Bukhari IA, Sheikh SA, Javed F. Short-term effects of adjunctive antimicrobial photodynamic therapy in obese patients with chronic periodontitis: A randomized controlled clinical trial. Photodiagnosis Photodyn Ther. 2018 Mar;21:10-15. doi: 10.1016/j.pdpdt.2017.10.022. Epub 2017 Oct 27.
Results Reference
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PubMed Identifier
37062511
Citation
da Silva-Junior PGB, Abreu LG, Costa FO, Cota LOM, Esteves-Lima RP. The effect of antimicrobial photodynamic therapy adjunct to non-surgical periodontal therapy on the treatment of periodontitis in individuals with type 2 diabetes mellitus: A systematic review and meta-analysis. Photodiagnosis Photodyn Ther. 2023 Jun;42:103573. doi: 10.1016/j.pdpdt.2023.103573. Epub 2023 Apr 14.
Results Reference
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Effects of Adjunct Antimicrobial Photodynamic Therapy in Periodontal Treatment of Patients With Obesity

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