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Clinical Applicability of PBS® CIMMO Cement in Pulpotomies

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ClinicalTrials.gov Identifier: NCT03200938
Recruitment Status : Recruiting
First Posted : June 27, 2017
Last Update Posted : July 2, 2017
Sponsor:
Information provided by (Responsible Party):
José Dias da Silva Neto, Universidade do Vale do Sapucai

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

Condition or disease Intervention/treatment Phase
Pulpotomy Device: formocresol and zinc oxide. Device: PBS CIMMO cement. Not Applicable

Detailed Description:

This is a randomized controlled clinical trial conducted at the Universidade do Vale do Sapucaí (UNIVAS), Pouso Alegre, Minas Gerais and the University of Vale do Rio Verde (UNINCOR) Três Corações, Minas Gerais. A project will be submitted to the Brazil Platform to UNIVÁS and UNINCOR ethics committees. Thirty children aged four to ten years old will be selected from the Pediatric Dentistry Clinic of the College of Dentistry of the Vale do Rio Verde Três Corações University. The sample will consist of 30 primary molars that show indication for pulpotomy. The inclusion criteria of the teeth to be selected are: absence of spontaneous painful symptomatology in the preoperative period, evidence of live red bleeding, cut resistance, associated with hemostasis after exposure of the pulp tissue. Radiographically, the teeth should present 2/3 of the root length, absence of radiolucent inter-radicular lesion and internal root resorption.

The technique recommended will be in a single session. Local anesthesia with 1: 100,000 articaine (DFL®) will be used a tube containing 1.8 ml. Absolute insulation with clamp 14 (IVORY®), rubber sheet (Madeitex®) and arch (JON®). The opening will be performed with a 1016 HL (KG®) drill and a dentin curette (Duflex®). All carious tissue and the coronary pulp will be removed with abundant irrigation.

In group A (control) the irrigation will be with physiological saline and then it will be applied in the pulp chamber with autoclaved cotton ball, formocresol for five minutes. Subsequently, calcium hydroxide cement base (Hidro C®), zinc oxide cement base and eugenol (IRM®) and restoration of the final tooth with composite resin will be inserted.

In group B the irrigation will be with sterile distilled water (the cement to be used loses its properties in front of the saline solution). Excess blood and distilled water from the irrigation will be sucked through disposable endodontic cannula (DFL®) and the fast trapped PBS®CIMMO cement will be handled through sterile glass plate and spatula 24 (Duflex®). Then it will be taken to the humid chamber with cement door, old amalgam (Duflex®) and condenser with Schilder condenser number 5 (Odus®). The cement will serve as a sub-base, base and final restoration.

Patients will be submitted to final radiographs and receive systemic medication with analgesic and anti-inflammatory. The evaluations will be carried out in 6 months and will be through clinical and radiographic examinations, to define the result of the treatments. Clinical examinations will be performed under artificial light through an exploratory probe (Duflex®) and clinical mirror (Duflex®). The clinical criteria to be observed are: edema, mobility, fistula and pain. The radiographic evaluations will be through periapical radiography with the aid of a radial ortho positioner (DFL®). In the radiographs will be observed the presence or absence of internal and external resorptions, as well as presence or absence of inter-radicular lesion.

The statistical analysis will be through the chi-square test and the level of significance will be 5%.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Comparative study with same series for the two groups
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Blind study, the patient is masked
Primary Purpose: Treatment
Official Title: Clinical Applicability of PBS® CIMMO Cement in Decoded Teeth Pulpotomies as Base and Restoration
Actual Study Start Date : October 2016
Estimated Primary Completion Date : August 2017
Estimated Study Completion Date : October 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: PBS CIMMO
Intervention: PBS CIMMO cement
Device: PBS CIMMO cement.
Removal of the coronary pulp from primary molar teeth, use of PBS cement
Other Name: PBS CIMMO technique
Active Comparator: Zinc oxide
Intervention: Formocresol and zinc oxide
Device: formocresol and zinc oxide.
Removal of the coronary pulp from primary molar teeth, use of formocresol and zinc oxide
Other Name: Formocresol and zinc oxide technique



Primary Outcome Measures :
  1. Clinical examination evaluate the repair capacity of PBS® CIMMO and Zinc Oxide cements in pulpotomies will be evaluated. [ Time Frame: 12 months ]
    The restorative capacity of the PBS CIMMO and Zinc Oxide cements will be assessed by clinical and radiographic examination six months after the pulpotomies.


Secondary Outcome Measures :
  1. Radiografhic examination evaluate the repair capacity of PBS CIMMO and Zinc Oxide [ Time Frame: 12 months ]
    The restorative capacity of CIMMO PBS and Zinc Oxide cements will be assessed by radiographic examination six months after pulpotomies.



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Ages Eligible for Study:   3 Years to 9 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

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

Exclusion Criteria:

  • 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

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): NCT03200938


Contacts
Contact: José neto 553534216910 jdendod@yahoo.com.br
Contact: Fernanda moyses 5535992083653 fermarins2@hotmail.com

Locations
Brazil
Fernanda Valadão Moysés Completed
Pouso Alegre, Minas Gerais, Brazil, 37550000
Univás Recruiting
Pouso Alegre, Minas Gerais, Brazil, 37550000
Contact: José dias Silva Neto, Doutor    5535988836910    jdendod@yahoo.com.br   
Contact: Fernanda Valadão Moysés, Mestranda    5535992083653    fermarins2@hotmail.com   
Sponsors and Collaborators
Universidade do Vale do Sapucai
Investigators
Principal Investigator: José Neto teacher

Responsible Party: José Dias da Silva Neto, Clinical Professor, Principal Investigator, Universidade do Vale do Sapucai
ClinicalTrials.gov Identifier: NCT03200938     History of Changes
Other Study ID Numbers: 57617816.9.0000.5102
First Posted: June 27, 2017    Key Record Dates
Last Update Posted: July 2, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by José Dias da Silva Neto, Universidade do Vale do Sapucai:
pulpotomy
Biological cement
Deciduous tooth

Additional relevant MeSH terms:
Zinc
Zinc Oxide
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Dermatologic Agents
Sunscreening Agents
Radiation-Protective Agents
Protective Agents