Clinical Applicability of PBS® CIMMO Cement in Pulpotomies

NCT ID: NCT03200938

Last Updated: 2020-12-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-31
• Study Completion Date: 2017-10-31

Brief Summary

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

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%.

Conditions

Pulpotomy

Keywords

pulpotomy; Biological cement; Deciduous tooth

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

PBS CIMMO

Intervention: PBS CIMMO cement

Group Type: EXPERIMENTAL

PBS CIMMO cement.

Intervention Type: DEVICE

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

Zinc oxide

Intervention: Formocresol and zinc oxide

Group Type: ACTIVE_COMPARATOR

formocresol and zinc oxide.

Intervention Type: DEVICE

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

Interventions

formocresol and zinc oxide.

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

Intervention Type: DEVICE

PBS CIMMO cement.

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

Intervention Type: DEVICE

Other Intervention Names

Formocresol and zinc oxide technique; PBS CIMMO technique

Eligibility 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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 9 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universidade do Vale do Sapucai

OTHER

Sponsor Role: lead

Responsible Party

José Dias da Silva Neto

Clinical Professor, Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

José Neto

Role: PRINCIPAL_INVESTIGATOR

teacher

Locations

Fernanda Valadão Moysés

Pouso Alegre, Minas Gerais, Brazil

Univás

Pouso Alegre, Minas Gerais, Brazil

Countries

Brazil

Other Identifiers

57617816.9.0000.5102

Identifier Type: -

Identifier Source: org_study_id