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

NCT ID: NCT06073704

Last Updated: 2024-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-09

Study Completion Date

2025-06-30

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.

Detailed Description

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Conditions

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Periodontitis Obesity

Keywords

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periodontitis obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
Participants will be masked using a sham laser. Outcomes assessor will be blinded in relation to naming of the experimental groups.

Study Groups

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Antimicrobial Photodynamic therapy adjunct to scaling and root planing

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

Group Type EXPERIMENTAL

antimicrobial photodynamic therapy (aPDT)

Intervention Type PROCEDURE

Scaling and root planing followed by antimicrobial photodynamic therapy

Control

Treatment of scaling and root planing.

Group Type ACTIVE_COMPARATOR

Control

Intervention Type PROCEDURE

Treatment of scaling and root planing

Interventions

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antimicrobial photodynamic therapy (aPDT)

Scaling and root planing followed by antimicrobial photodynamic therapy

Intervention Type PROCEDURE

Control

Treatment of scaling and root planing

Intervention Type PROCEDURE

Other Intervention Names

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Photodynamic therapy Photochemotherapy scaling and root planing

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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Carla Andreotti Damante

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Bauru School of Dentistry

Bauru, São Paulo, Brazil

Site Status RECRUITING

Countries

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Brazil

Facility Contacts

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Carla Damante, PhD

Role: primary

Andreia Pavani, PhD

Role: backup

Carla Damante, PhD

Role: backup

Andreia Pavani, PhD

Role: backup

References

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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.

Reference Type BACKGROUND
PMID: 29111391 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 37062511 (View on PubMed)

Other Identifiers

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Obesity and Periodontitis

Identifier Type: -

Identifier Source: org_study_id