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Recruiting NCT06073704

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

No phase Interventional Periodontitis Obesity

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: antimicrobial photodynamic therapy (aPDT), Control.
Who it may be relevant to
Registry conditions: Periodontitis, Obesity. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Brazil
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

  • Procedure antimicrobial photodynamic therapy (aPDT)
    Scaling and root planing followed by antimicrobial photodynamic therapy
  • Procedure Control
    Treatment of scaling and root planing

Primary outcome measures

  • Probing depth [Time frame: Baseline, 1, 3 and 6 months]
  • Clinical attachment level [Time frame: Baseline, 1, 3 and 6 months]
Secondary outcome measures (2)
  • Changes on bleeding on probing [Time frame: Baseline, 1,3,and 6 months]
  • Differences in proteomics [Time frame: baseline, 3 and 6 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Brazil · 1 center
  • Bauru School of Dentistry — Bauru

Publications

  • 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. PMID 29111391
  • 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. PMID 37062511

Identifiers

NCT: NCT06073704 · Obesity and Periodontitis

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗