Effectiveness of Photodynamic Therapy for Endodontic Treatment of Deciduous Teeth

May 3, 2017 updated by: Sandra Kalil Bussadori, University of Nove de Julho

Evaluation of the Effectiveness of Photodynamic Therapy as a Supporting for Endodontic Treatment of Deciduous Teeth

The elimination of pathogenic microorganisms from the root canal system is one of the main points in order to have success in endodontic treatment. The objective of this study is to perform a randomized controlled clinical trial to compare the effectiveness of success in endodontic treatment of primary teeth when combined with photodynamic therapy. Will be selected 30 primary teeth of children aged between 3 and 6 years. The teeth will be divided into two groups: group I control, which will be applied the conventional endodontic treatment and group II to be held endodontic treatment with application of photodynamic therapy. In both groups will be made microbiological evaluations before and after endodontic treatment and clinical and radiographic evaluations will be conducted in the day, 1 month, 3 months and 6 months after treatment comparing the treatment performed in both groups.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Interventions All treatment procedures will be performed by a single, duly trained operator. Group I (control) - conventional endodontic treatment

  1. Prophylaxis with pumice stone and water and antisepsis of region with 0.12% solution of chlorhexidine using moistened gauze
  2. Anesthesia
  3. Absolute isolation, if possible; in cases of considerable loss of remaining tooth, relative isolation using cotton rolls
  4. Opening of crown with spherical diamond tip burs (bur size compatible with tooth) (KG Sorensen - Indústria e Comércio, SP, Brazil) and high speed Z endodontic drill under water and air refrigeration
  5. Millimeter measurement of root canal to 1 mm short of radiographic apex
  6. Insertion of three sterile paper cones with diameter compatible with canal for 30 seconds for initial collection of bacterial sample and immediate placement into brain heart infusion broth
  7. Surgical chemical preparation with series of Kerr files appropriate for each case, using initial file and an additional two files of larger size, with irrigation and aspiration with 1% sodium hypochlorite (Milton's solution) and endo PTC (Fórmula & Ação) with each change of file
  8. Insertion of three sterile paper cones for 30 seconds for second collection of bacterial sample and immediate placement into brain heart infusion broth
  9. Filling of root canals with calcium hydroxide (Ultra-cal, Ultradent, Brazil); base of thin gutta-percha and filling with glass ionomer cement; restorative treatment performed in subsequent session

Group II - Conventional endodontic treatment + PDT

  1. Prophylaxis with pumice stone and water and antisepsis of region with 0.12% solution of chlorhexidine using moistened gauze
  2. Anesthesia
  3. Absolute isolation, if possible; in cases of considerable loss of remaining tooth, relative isolation using cotton rolls
  4. Opening of crown with spherical diamond tip burs (bur size compatible with tooth) (KG Sorensen - Indústria e Comércio, SP, Brazil) and high speed Z endodontic drill under water and air refrigeration
  5. Millimeter measurement of root canal to 1 mm short of radiographic apex
  6. Insertion of three sterile paper cones with diameter compatible with canal for 30 seconds for initial collection of bacterial sample and immediate placement into brain heart infusion broth
  7. Insertion of sterile paper cone immersed in Chimiolux® methylene blue for three minutes; administration of wireless Therapy XT EC laser device (DMC - São Carlos, Brazil) after removal of cone; energy density: 4 J/cm², power: 100 mw; wavelength: 660 nm; exposure time: 40 seconds
  8. Root canal irrigated with sterile saline solution and insertion of three sterile paper cones for 30 seconds for second collection of bacterial sample and immediate placement in brain heart infusion broth
  9. Filling of root canals with calcium hydroxide (Ultra-cal, Ultradent, Brazil); base of thin gutta-percha and filling with glass ionomer cement; restorative treatment performed in subsequent session

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 1

Contacts and Locations

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

Study Contact

Study Locations

  • Brazil
      • São Paulo, Brazil, 04106001
        • Recruiting
        • University of Nove de Julho
        • 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

1 year to 4 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients aged 3 to 6 years old with at least one anterior deciduous tooth with irreversible pulpitis or pulp necrosis in a position to be restored and at least 2/3 of the remaining root.
  • Healthy patients and who did not antibiotic treatment in the previous three months.

Exclusion Criteria:

  • Patients in poor health, with primary teeth with large root loss (+ 2/3 root), which has no internal pathological resorption, reconstruction is not possible, cases of retreatment and crypt involvement.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Covencional treatment

Convencional endodontic treatment for deciduous teeth, with Surgical chemical preparation with series of Kerr files appropriate for each case, using initial file and an additional two files of larger size, with irrigation and aspiration with 1% sodium hypochlorite (Milton's solution) and endo PTC (Fórmula & Ação) with each change of file.

Filling of root canals with calcium hydroxide (Ultra-cal, Ultradent, Brazil); base of thin gutta-percha and filling with glass ionomer cement; restorative treatment performed in subsequent session.
Procedure: Endodontic treatment
It will be done the endodontic treatment using the photosynamic therapy for decontamination of the root chanel.
Experimental: Photodynamic therapy
Endodontic Treatment with photodynamic terapy Irrigation of the root canal system Insertion of sterile paper cone immersed in Chimiolux® methylene blue for three minutes; administration of wireless Therapy XT EC laser device (DMC - São Carlos, Brazil) after removal of cone; energy density: 4 J/cm², power: 100 mw; wavelength: 660 nm; exposure time: 40 seconds Filling of root canals with calcium hydroxide (Ultra-cal, Ultradent, Brazil); base of thin gutta-percha and filling with glass ionomer cement; restorative treatment performed in subsequent session
Procedure: Endodontic treatment
It will be done the endodontic treatment using the photosynamic therapy for decontamination of the root chanel.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical evaluation.
Time Frame: 6 months
If the teeth doesn´t has any sympton like pain, fistula etc...
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiographic evaluation
Time Frame: 6 mounth
Periapical lesion (Yes or No).
6 mounth
Microbiological evaluation
Time Frame: Before and after the treatment (same day)
UFC/ml before and after treatment
Before and after the treatment (same day)

Collaborators and Investigators

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

Sponsor

University of Nove de Julho

Investigators

  • Principal Investigator: Sandra Bussadori, PhD, University of Nove de Julho

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

April 29, 2017

Primary Completion (Anticipated)

October 1, 2017

Study Completion (Anticipated)

April 1, 2018

Study Registration Dates

First Submitted

June 9, 2015

First Submitted That Met QC Criteria

June 25, 2015

First Posted (Estimate)

June 30, 2015

Study Record Updates

Last Update Posted (Actual)

May 8, 2017

Last Update Submitted That Met QC Criteria

May 3, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 832.657

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.

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