ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03186352
Recruitment Status : Recruiting
First Posted : June 14, 2017
Last Update Posted : August 4, 2017
Sponsor:
Information provided by (Responsible Party):
Medical University of Warsaw

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.


Condition or disease Intervention/treatment Phase
Primary Root Caries Procedure: photoactivated disinfection Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Supportive Care
Official Title: Clinical Effect of Photoactivated Disinfection on Primary Root Carious Lesions After Partial Caries Removal
Actual Study Start Date : July 11, 2017
Estimated Primary Completion Date : December 31, 2017
Estimated Study Completion Date : February 28, 2018

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. elimination of bacteria [ Time Frame: 7 day ]
    determination of amount of Colony Forming Units per ml



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03186352


Contacts
Contact: Tomasz A Gajewski 530404844 tomekgajewski88@gmail.com

Locations
Poland
Zakład Stomatologii Zachowawczej Recruiting
Warsaw, Woj. Mazowieckie, Poland, 26-610
Contact: Gajewski Tomasz Aleksander    0048530404844    tgajewski@wum.edu.pl   
Sponsors and Collaborators
Medical University of Warsaw

Responsible Party: Medical University of Warsaw
ClinicalTrials.gov Identifier: NCT03186352     History of Changes
Other Study ID Numbers: WarsawMUKB/32/2016/1
First Posted: June 14, 2017    Key Record Dates
Last Update Posted: August 4, 2017
Last Verified: August 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Medical University of Warsaw:
photodynamic therapy
photoactivated disinfection
primary root caries lesion
cavity disinfection
lasers
root caries

Additional relevant MeSH terms:
Dental Caries
Root Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases