NCT02485210

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Apr 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 9, 2015

Completed
21 days until next milestone

First Posted

Study publicly available on registry

June 30, 2015

Completed
1.8 years until next milestone

Study Start

First participant enrolled

April 29, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

May 8, 2017

Status Verified

May 1, 2017

Enrollment Period

5 months

First QC Date

June 9, 2015

Last Update Submit

May 3, 2017

Conditions

Tooth, Nonvital

Keywords

photodynamic therapy , Endodontic treatment

Outcome Measures

Primary Outcomes (1)

  • Clinical evaluation.

    If the teeth doesn´t has any sympton like pain, fistula etc...

    6 months

Secondary Outcomes (2)

  • Radiographic evaluation

    6 mounth

  • Microbiological evaluation

    Before and after the treatment (same day)

Study Arms (2)

Covencional treatment

ACTIVE COMPARATOR

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

Photodynamic therapy

EXPERIMENTAL

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

Interventions

Endodontic treatmentPROCEDURE

It will be done the endodontic treatment using the photosynamic therapy for decontamination of the root chanel.

Covencional treatmentPhotodynamic therapy

Eligibility Criteria

Age3 Years - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Nove de Julho

São Paulo, 04106001, Brazil

RECRUITING

Related Publications (1)

  • da Mota AC, Goncalves ML, Bortoletto C, Olivan SR, Salgueiro M, Godoy C, Altavista OM, Pinto MM, Horliana AC, Motta LJ, Bussadori SK. Evaluation of the effectiveness of photodynamic therapy for the endodontic treatment of primary teeth: study protocol for a randomized controlled clinical trial. Trials. 2015 Dec 3;16:551. doi: 10.1186/s13063-015-1086-2.

    PMID: 26635011DERIVED

MeSH Terms

Conditions

Tooth, Nonvital

Interventions

Endodontics

Condition Hierarchy (Ancestors)

Dental Pulp DiseasesTooth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dentistry

Study Officials

  • Sandra Bussadori, PhD

    University of Nove de Julho

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ana Carolina Mota, Masters

CONTACT

5511979889199ana_cmota@yahoo.com.br

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

June 9, 2015

First Posted

June 30, 2015

Study Start

April 29, 2017

Primary Completion

October 1, 2017

Study Completion

April 1, 2018

Last Updated

May 8, 2017

Record last verified: 2017-05

Locations

BR(1)