NCT03200938

Brief Summary

Randomized clinical study in pulpotomies of deciduous molar teeth. A comparison of two techniques is established.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2016

Geographic Reach
1 country

2 active sites

Status
completed

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

Study Start

First participant enrolled

October 1, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 3, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 27, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 28, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

December 31, 2020

Status Verified

December 1, 2020

Enrollment Period

11 months

First QC Date

May 3, 2017

Last Update Submit

December 30, 2020

Conditions

Pulpotomy

Keywords

pulpotomyBiological cementDeciduous tooth

Outcome Measures

Primary Outcomes (1)

  • Clinical examination evaluate the repair capacity of PBS® CIMMO and Zinc Oxide cements in pulpotomies will be evaluated.

    The restorative capacity of the PBS CIMMO and Zinc Oxide cements will be assessed by clinical and radiographic examination six months after the pulpotomies.

    12 months

Secondary Outcomes (1)

  • Radiografhic examination evaluate the repair capacity of PBS CIMMO and Zinc Oxide

    12 months

Study Arms (2)

PBS CIMMO

EXPERIMENTAL

Intervention: PBS CIMMO cement

Device: PBS CIMMO cement.

Zinc oxide

ACTIVE COMPARATOR

Intervention: Formocresol and zinc oxide

Device: formocresol and zinc oxide.

Interventions

formocresol and zinc oxide.DEVICE

Removal of the coronary pulp from primary molar teeth, use of formocresol and zinc oxide

Also known as: Formocresol and zinc oxide technique
Zinc oxide
PBS CIMMO cement.DEVICE

Removal of the coronary pulp from primary molar teeth, use of PBS cement

Also known as: PBS CIMMO technique
PBS CIMMO

Eligibility Criteria

Age3 Years - 9 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Teeth exhibiting caries exposure
  • Teeth with incomplete rhizogenesis
  • Absence of periradicular lesion and fistula
  • Accidental pulp exposure

You may not qualify if:

  • Teeth with spontaneous pain
  • Teeth With impossibility to perform absolute isolation
  • Teeth with mobility, presence of fistula and root resorption of more than two-thirds of the root
  • Teeth unable to be restored
  • Teeth with painful response after vertical percussion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Fernanda Valadão Moysés

Pouso Alegre, Minas Gerais, 37550000, Brazil

Location

Univás

Pouso Alegre, Minas Gerais, 37550000, Brazil

Location

Study Officials

  • José Neto

    teacher

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Blind study, the patient is masked
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Comparative study with same series for the two groups
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor, Principal Investigator

Study Record Dates

First Submitted

May 3, 2017

First Posted

June 27, 2017

Study Start

October 1, 2016

Primary Completion

August 28, 2017

Study Completion

October 1, 2017

Last Updated

December 31, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations

BR(2)