Clinical trial NCT03186352: Clinical Effect of Photoactivated Disinfection on Primary Root Carious Lesions After Partial Caries Removal
Official title: Clinical Effect of Photoactivated Disinfection on Primary Root Carious Lesions After Partial Caries Removal
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Primary Root Caries
Keywords: photodynamic therapy
photoactivated disinfection
primary root caries lesion
cavity disinfection
lasers
root caries
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
First posted: 2017-06-14
Enrollment: 15
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Sample for microbiological evaluation is to be taken from each patient before and after intervention (PAD). Before-After Study Type.
Primary purpose: SUPPORTIVE_CARE

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)

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

Primary outcomes:
measure: elimination of bacteria
timeFrame: 7 day
Secondary outcomes:
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Zakład Stomatologii Zachowawczej
state: Woj. Mazowieckie
Study officials:
References: