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

August 3, 2017 updated by: Medical University of Warsaw

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
    • Woj. Mazowieckie
      • Warsaw, Woj. Mazowieckie, Poland, 26-610
        • Recruiting
        • Zakład Stomatologii Zachowawczej
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: after intervention
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

Other Names:
  • Photodynamic therapy
  • photodynamic antimicrobial chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
elimination of bacteria
Time Frame: 7 day
determination of amount of Colony Forming Units per ml
7 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Warsaw

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 11, 2017

Primary Completion (Anticipated)

December 31, 2017

Study Completion (Anticipated)

February 28, 2018

Study Registration Dates

First Submitted

June 12, 2017

First Submitted That Met QC Criteria

June 13, 2017

First Posted (Actual)

June 14, 2017

Study Record Updates

Last Update Posted (Actual)

August 4, 2017

Last Update Submitted That Met QC Criteria

August 3, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WarsawMUKB/32/2016/1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Primary Root Caries

Clinical Trials on photoactivated disinfection

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uzbekistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe