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Status unknownNCT03186352PADUpdated Aug 4, 2017

Clinical Effect of Photoactivated Disinfection on Primary Root Carious Lesions After Partial Caries Removal

An interventional study of photoactivated disinfection in Primary Root Caries, sponsored by Medical University of Warsaw. Status unknown at 1 site in Poland. Open to participants aged 45 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-08-04.

Sponsored by Medical University of Warsaw · Not applicable, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified Aug 2017), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Not applicable
Ages
45 Years and older
Sex
All
01

Study summary

The problem of root caries has been increasing in last decades as the an average life expectancy is rising. Due to progress of medicine and dentistry humans also maintain natural dentition longer.

The aim of the study is to determine the effectiveness of photoactivated disinfection / photodynamic therapy / photodynamic antimicrobial therapy in elimination of cariogenic bacteria after manual root caries removal.

If proved to be effective in eliminating bacteria from prepared cavity PAD could be incorporated in the protocol of treatment of root cavities.

Read the detailed description

Elimination of cariogenic bacteria is to be determined in this study - Mutans streptococci, Lactobacillus spp. and Actinomyces spp.

After manual preparation of the cavity with an excavator and taking a sample for a microbial analysis with a rose bur on micro motor (size 014) the cavity undergoes the procedure of photodynamic disinfection:

  • application of photosensitizer 'Fotosan Agent' (CMS Dental, Denmark) for 5 minutes,
  • radiation with low power laser, wavelength 635 nm power 200mW 120 s. ('Lasotronix', DiodeLX model SMART)
  • rinsing with water and drying

After photodynamic disinfection another sample for microbial analysis is taken form the neighboring area to get the material for a comparison analysis.

Filling the cavity with a material for permanent fillings (glass-ionomer cement)

Samples are inoculated on:

  • Mitis-Salivarius ('Difco') for Streptococci
  • Rogosa SL 2% aqar ('Oxoid') for Lactobacillus
  • Columbia with blood for Actinomyces (2 dilutions - 1:10 and 1:100)
02

Conditions studied

  • Primary Root Caries

Keywords

  • photodynamic therapy
  • photoactivated disinfection
  • primary root caries lesion
  • cavity disinfection
  • lasers
  • root caries
03

Who can participate

Ages eligible
45 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • more than 10 teeth
  • at least one tooth with primary caries lesion with contraindicated non-invasive treatment (lesion which needs to be prepared and filled with material for permanent fillings); tooth with no clinical and/or radiological symptoms of pulp involvement.
  • no systemic disease

Exclusion criteria

Exclusion Criteria:

  • systemic diseases (may affect saliva flow and properties)
  • antibiotic therapy in previous 3 months before the appointment
04

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
15 participants (estimated)

Study arms

  • Experimental
    after intervention

    sample for microbial analysis it taken with sterile a rose bur (size 014) on micro motor after intervention

    Procedure: photoactivated disinfection

Interventions

  • Procedurephotoactivated disinfection

    After manual preparation of the cavity with an excavator and taking a sample for a microbial analysis with a rose bur on micro motor (size 014) the cavity undergoes the procedure of photodynamic disinfection: application of photosensitizer 'Fotosan' Agent (CMS Dental, Denmark) for 5 minutes, radiation with low power laser, wavelength 635 nm power 200mW 120 s. ('Lasotronix', DiodeLX model SMART) rinsing with water and drying

    Also known as: Photodynamic therapy, photodynamic antimicrobial chemotherapy

05

What researchers measure

Primary outcomes

  1. elimination of bacteria

    determination of amount of Colony Forming Units per ml

    Time frame: 7 day

06

Study locations

1 of 1 sites recruiting
  • Zakład Stomatologii Zachowawczej
    Warsaw, Woj. Mazowieckie 26-610, Poland
    Recruiting
07

Registry details

Key details

Study ID
NCT03186352
Lead sponsor
Medical University of Warsaw
Responsible party
Sponsor
First posted
Jun 14, 2017
Start date
Jul 11, 2017
Primary completion
Dec 31, 2017 (estimated)
Completion
Feb 28, 2018 (estimated)
Last update
Aug 4, 2017

Study contacts

Tomasz A Gajewski
Contact
tomekgajewski88@gmail.com
530404844

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.

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