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 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.
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:
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:
39 studies on the registry are indexed under Root Caries; 14 are open to participants now.
This study's planned enrollment of 15 is below the median of 62 across 35 interventional studies indexed under Root Caries.
Browse Root Caries studies →Medical University of Warsaw is the lead sponsor of 326 studies on the registry; 87 are open to participants now.
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A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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sample for microbial analysis it taken with sterile a rose bur (size 014) on micro motor after intervention
Procedure: photoactivated 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
elimination of bacteria
determination of amount of Colony Forming Units per ml
Time frame: 7 day
Started Jul 2017 (actual). Primary completion is estimated for Dec 2017, 5 months after the start.
Of 21 interventional studies with no phase under Root Caries, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 55. This study's planned 5 months is below that.
How these figures are worked out, and which studies are left out of them.
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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