Clinical Applicability of PBS® CIMMO Cement in Pulpotomies
|ClinicalTrials.gov Identifier: NCT03200938|
Recruitment Status : Recruiting
First Posted : June 27, 2017
Last Update Posted : July 2, 2017
|Condition or disease||Intervention/treatment||Phase|
|Pulpotomy||Device: formocresol and zinc oxide. Device: PBS CIMMO cement.||Not Applicable|
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|
|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|
|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|
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
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03200938
|Contact: José email@example.com|
|Contact: Fernanda firstname.lastname@example.org|
|Fernanda Valadão Moysés||Completed|
|Pouso Alegre, Minas Gerais, Brazil, 37550000|
|Pouso Alegre, Minas Gerais, Brazil, 37550000|
|Contact: José dias Silva Neto, Doutor 5535988836910 email@example.com|
|Contact: Fernanda Valadão Moysés, Mestranda 5535992083653 firstname.lastname@example.org|
|Principal Investigator:||José Neto||teacher|