Clinical Effect of Photoactivated Disinfection on Primary Root Carious Lesions After Partial Caries Removal (PAD)
Primary Purpose
Primary Root Caries
Status
Unknown status
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
photoactivated disinfection
Sponsored by
About this trial
This is an interventional supportive care trial for Primary Root Caries focused on measuring photodynamic therapy, photoactivated disinfection, primary root caries lesion, cavity disinfection, lasers, root caries
Eligibility Criteria
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:
- systemic diseases (may affect saliva flow and properties)
- antibiotic therapy in previous 3 months before the appointment
Sites / Locations
- Zakład Stomatologii ZachowawczejRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
after intervention
Arm Description
sample for microbial analysis it taken with sterile a rose bur (size 014) on micro motor after intervention
Outcomes
Primary Outcome Measures
elimination of bacteria
determination of amount of Colony Forming Units per ml
Secondary Outcome Measures
Full Information
NCT ID
NCT03186352
First Posted
June 12, 2017
Last Updated
August 3, 2017
Sponsor
Medical University of Warsaw
1. Study Identification
Unique Protocol Identification Number
NCT03186352
Brief Title
Clinical Effect of Photoactivated Disinfection on Primary Root Carious Lesions After Partial Caries Removal
Acronym
PAD
Official Title
Clinical Effect of Photoactivated Disinfection on Primary Root Carious Lesions After Partial Caries Removal
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Unknown status
Study Start Date
July 11, 2017 (Actual)
Primary Completion Date
December 31, 2017 (Anticipated)
Study Completion Date
February 28, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of Warsaw
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Root Caries
Keywords
photodynamic therapy, photoactivated disinfection, primary root caries lesion, cavity disinfection, lasers, root caries
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Sample for microbiological evaluation is to be taken from each patient before and after intervention (PAD). Before-After Study Type.
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
after intervention
Arm Type
Experimental
Arm Description
sample for microbial analysis it taken with sterile a rose bur (size 014) on micro motor after intervention
Intervention Type
Procedure
Intervention Name(s)
photoactivated disinfection
Other Intervention Name(s)
Photodynamic therapy, photodynamic antimicrobial chemotherapy
Intervention Description
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
Primary Outcome Measure Information:
Title
elimination of bacteria
Description
determination of amount of Colony Forming Units per ml
Time Frame
7 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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:
systemic diseases (may affect saliva flow and properties)
antibiotic therapy in previous 3 months before the appointment
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tomasz A Gajewski
Phone
530404844
Email
tomekgajewski88@gmail.com
Facility Information:
Facility Name
Zakład Stomatologii Zachowawczej
City
Warsaw
State/Province
Woj. Mazowieckie
ZIP/Postal Code
26-610
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gajewski Tomasz Aleksander
Phone
0048530404844
Email
tgajewski@wum.edu.pl
12. IPD Sharing Statement
Learn more about this trial
Clinical Effect of Photoactivated Disinfection on Primary Root Carious Lesions After Partial Caries Removal
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