Primary Root CariesPADNCT03186352
Clinical Effect of Photoactivated Disinfection on Primary Root Carious Lesions After Partial Caries Removal
A study testing photoactivated disinfection in people with Primary Root Caries, run by Medical University of Warsaw at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 years and olderHealthy volunteers can take part
- Conditions the study is for
- Primary Root Caries
- What is being tested?
- photoactivated disinfection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 sitePoland
- Study dates
- 11 Jul 2017to 28 Feb 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- systemic diseases (may affect saliva flow and properties)
- antibiotic therapy in previous 3 months before the appointment
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Zakład Stomatologii Zachowawczej
Warsaw, Woj. Mazowieckie, 26-610
Gajewski Tomasz Aleksander, 0048530404844, tgajewski@wum.edu.pl
About this study
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)
- Conditions
- Primary Root Caries
- Being tested
- photoactivated disinfection
- Keywords
- photodynamic therapy, photoactivated disinfection, primary root caries lesion, cavity disinfection, lasers, root caries
- Medical subject headings
- Root Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
photoactivated disinfectionProcedure or surgery
Also called Photodynamic therapy, photodynamic antimicrobial chemotherapy
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
| Study group | Role | What they receive |
|---|---|---|
| after intervention | Experimental | sample for microbial analysis it taken with sterile a rose bur (size 014) on micro motor after intervention Receives: Procedure: photoactivated disinfection |
What is being measured
The primary outcome is the main question the study is designed to answer.
elimination of bacteria
determination of amount of Colony Forming Units per ml
Measured: 7 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2017
- Study start11 Jul 2017
- Primary completion31 Dec 2017 (estimated)
- Study completion28 Feb 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Root CariesStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03186352
- Sponsor's protocol ID
- WarsawMUKB/32/2016/1
- Acronym
- PAD
- Status last verified
- Aug 2017
- First submitted
- 12 Jun 2017
- Last updated
- 4 Aug 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Effect of Photoactivated Disinfection on Primary Root Carious Lesions After Partial Caries Removal
- ClinicalTrials.gov ID
- NCT03186352
- Acronym / sponsor ID
- PAD / WarsawMUKB/32/2016/1
- Conditions
- Primary Root Caries
- Keywords
- photodynamic therapy, photoactivated disinfection, primary root caries lesion, cavity disinfection, lasers, root caries
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- 11 Jul 2017 (actual)
- Primary completion
- 31 Dec 2017 (estimated)
- Study completion
- 28 Feb 2018 (estimated)
- First posted
- 14 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Sample for microbiological evaluation is to be taken from each patient before and after intervention (PAD). Before-After Study Type.
| Arm | Type | Receives |
|---|---|---|
| after intervention | Experimental | Procedure: photoactivated disinfectionsample for microbial analysis it taken with sterile a rose bur (size 014) on micro motor after intervention |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- systemic diseases (may affect saliva flow and properties)
- antibiotic therapy in previous 3 months before the appointment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| photoactivated disinfectionAlso: Photodynamic therapy, photodynamic antimicrobial chemotherapyAfter 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 | Procedure or surgery | after intervention |
Primary outcome
elimination of bacteria
Time frame: 7 day
determination of amount of Colony Forming Units per ml
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2017.
Related trials for Primary Root Caries
Not yet recruiting
Moringa Oleifera vs Sodium Hypochlorite for Root Canal Irrigation in Nonvital Primary Molars
Dental Caries, Pulp Necrosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing photoactivated disinfection in people with Primary Root Caries, run by Medical University of Warsaw at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tomasz A Gajewski (530404844, tomekgajewski88@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
elimination of bacteria (time frame: 7 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2017.