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Clinical Applicability of PBSCIMMO as a Single Material in Endodontic Obturations (PBSCIMMO)

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ClinicalTrials.gov Identifier: NCT03514264
Recruitment Status : Enrolling by invitation
First Posted : May 2, 2018
Last Update Posted : June 5, 2018
Sponsor:
Information provided by (Responsible Party):
Rubia Moura Leite Boczar, Universidade do Vale do Sapucai

Brief Summary:
A randomized, interventional, prospective, unicentric clinical study, 86 patients will be submitted to endodontic treatment of necrotic teeth. 43 patients will complete treatment with obturation with AHPlus cement and Gutta-Percha cones (group A) and 43 patients will complete treatment with PBS® CIMMO cement (single material) (group B). The primary outcome will be the repair of the periradicular lesion demonstrated by integrity of the hard blade throughout the perimeter of the root identified by Tomography Cone Beam, performed after 6 months of treatment. The secondary endpoint will be the absence of fistula after 6 months of treatment identified by clinical examination.

Condition or disease Intervention/treatment Phase
Root Canal Therapy Procedure: Gutta Percha and AHPLUS cement (group A) Procedure: PBS CIMMO cement (group B) Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A randomized, interventional, prospective, unicentric, double blind clinical trial.
Masking: Single (Outcomes Assessor)
Masking Description: After 6 months the results will be evaluated by two independent professionals, who did not participate in the interventions and are not aware of the allocation. The evaluation will be performed by means of tomography and clinical examination
Primary Purpose: Treatment
Official Title: Clinical Applicability of PBSCIMMO as a Single Material in Endodontic Obturations
Actual Study Start Date : November 9, 2017
Estimated Primary Completion Date : June 5, 2018
Estimated Study Completion Date : February 26, 2019

Arm Intervention/treatment
Experimental: GUTTA PERCHA and AHPLUS cement (group A)
43 patients will undergo endodontic treatment with obturation with AHPlus cement and Gutta-Percha cones. This treatment will be performed in 2 sessions. First intervention: endodontic instrumentation and introduction of intra-canal medication that will remain in the tooth for 4 weeks. Second intervention: removal of intracanal medication and filling with cement and gutta percha AHPlus.
Procedure: Gutta Percha and AHPLUS cement (group A)

First intervention: endodontic instrumentation and introduction of intact medication that will remain inside the tooth for 4 weeks.

Second intervention: removal of intracanal medication and canal filling with cement AHPLUS and guttapercha


Experimental: PBS CIMMO cement (group B)
43 patients will undergo endodontic treatment with PBS CIMMO® cement (single material).This treatment will be performed in 1 session.Single intervention: endodontic instrumentation and cement filling PBS CIMMO.
Procedure: PBS CIMMO cement (group B)
Single intervention: endodontic instrumentation and obturation with cement PBS CIMMO




Primary Outcome Measures :
  1. Patients with necrotic teeth and periradicular lesion evaluated by cone beam tomography [ Time Frame: Patients will return six months after the procedure to undergo a exam cone Beam tomografy ]
    The data will be aggregated by presence of hard blade that determines the phylogenetic parameter of success of the treatment. This physiological parameter is the presence of hard blade integrated in the tomography image, which will determine healthy periodontal ligament


Secondary Outcome Measures :
  1. Clinical examination of patients' treated teeth [ Time Frame: Patients will return six months after the procedure to undergo a clinical examination ]
    The physiological parameter for this examination will be the absence of fistula that will determine treatment success



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients presenting with a diagnosis of necrosis.

Exclusion Criteria:

  • Patients who drop out during the study
  • Patients who do not return to the final exam after 6 months.
  • Patients who present more than one tooth in need of treatment will choose only one tooth, the others will be excluded.

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): NCT03514264


Locations
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Brazil
Rubia Moura Leite Boczar
Pouso Alegre, MG, Brazil, 37550000
Sponsors and Collaborators
Universidade do Vale do Sapucai
Investigators
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Principal Investigator: Rubia Boczar Univás-Universidade do Vale do Sapucaí- Pouso Alegre Minas Geraes
Study Director: Taylor b Schnaider, MD,PhD Universidade Vale do Sapucaí
Study Chair: Daniela F Veiga, MD,PhD Universidade Vale do Sapucaí

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Responsible Party: Rubia Moura Leite Boczar, Principal investigator, Universidade do Vale do Sapucai
ClinicalTrials.gov Identifier: NCT03514264     History of Changes
Other Study ID Numbers: PBS
First Posted: May 2, 2018    Key Record Dates
Last Update Posted: June 5, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rubia Moura Leite Boczar, Universidade do Vale do Sapucai:
Endodontics
Biomaterials
Dental pulp cavity
Periapical abscess
Root canal therapy
Root canal obturation