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

Primary Root Caries Clinical Trial

— PAD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03186352
• Other study ID #: WarsawMUKB/32/2016/1
• Status: Recruiting
• Phase: N/A
• First received: June 12, 2017
• Last updated: August 3, 2017
• Start date: July 11, 2017
• Est. completion date: February 28, 2018

Study information

• Verified date: August 2017
• Source: Medical University of Warsaw
• Contact: Tomasz A Gajewski
• Phone: 530404844
• Email: tomekgajewski88[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: February 28, 2018
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dental Caries
• Primary Root Caries
• Root Caries

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

Locations

Country	Name	City	State
Poland	Zaklad Stomatologii Zachowawczej	Warsaw	Woj. Mazowieckie

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Warsaw

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	elimination of bacteria	determination of amount of Colony Forming Units per ml	7 day