Applicability Clinic of Cement Portland Structural White in Endodontic Surgery
Primary Purpose
Mandibular Hypoplasia
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
ENDODONTIC SURGERY
Sponsored by
About this trial
This is an interventional treatment trial for Mandibular Hypoplasia focused on measuring Apicoectomy, Oral surgery, Biocompatible materials, Dental Cements, Translational Medical Research
Eligibility Criteria
Inclusion Criteria:
- patients were diagnosed by computed tomography CT, cone beam
- each of them had from two to four compromised teeth
Exclusion Criteria:
- patients who did not return for review after six months
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
TOOTH ENDODONTIC SURGERY - PBEA
TOOTH ENDODONTIC SURGERY -MTA
Arm Description
Endodontic surgery 15 teeth - PBEA
Endodontic surgery 15 teeth - MTA
Outcomes
Primary Outcome Measures
Regeneration measured by tomographers endodontic surgery
Six months after surgery, there were new scans to evaluate the repair or not the wounds.
Secondary Outcome Measures
Full Information
NCT ID
NCT02474615
First Posted
February 24, 2015
Last Updated
June 17, 2015
Sponsor
Universidade do Vale do Sapucai
1. Study Identification
Unique Protocol Identification Number
NCT02474615
Brief Title
Applicability Clinic of Cement Portland Structural White in Endodontic Surgery
Official Title
Applicability Clinic of Cement Portland Structural White in Endodontic Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
January 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade do Vale do Sapucai
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Thirty teeth twelve patients, two female and a male, who had persistent periradicular lesions were selected to participate in this study. The lesions were diagnosed with cone-beam computed tomography (cone-beam CT; Model i-Cat 17-19, Imaging Sciences International LLC).In patients with two teeth to be treated, a tooth was retroobturado with PBEA cement, (experiment) and another tooth was retroobturado with MTA cement (control).
There was significance for the two cements on the repair of wounds. Key words: Apicoectomy; Oral Surgery; Biocompatible Materials; Dental Cements; Translational Medical Research
Detailed Description
Objective: to evaluate the clinical applicability of structural Portland white cement additive in retrofilling surgeries. Method: persistent apical periodontitis 30 teeth of 12 patients were diagnosed by computed tomography CT, cone beam. Each of them had from two to four compromised teeth. The endodontic surgery were performed and the teeth were retrofilling Each patient had a retrofilling tooth with cement mineral trioxide aggregate (MTA) control and other tooth with white Portland cement structural additive (PBEA) experiment. When the patient presented four teeth with injury, two were retrofilling with MTA and two Portland cement with structural white cement additive. Six months after surgery, there were new scans to evaluate the repair or not the wounds.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mandibular Hypoplasia
Keywords
Apicoectomy, Oral surgery, Biocompatible materials, Dental Cements, Translational Medical Research
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TOOTH ENDODONTIC SURGERY - PBEA
Arm Type
Experimental
Arm Description
Endodontic surgery 15 teeth - PBEA
Arm Title
TOOTH ENDODONTIC SURGERY -MTA
Arm Type
Experimental
Arm Description
Endodontic surgery 15 teeth - MTA
Intervention Type
Procedure
Intervention Name(s)
ENDODONTIC SURGERY
Intervention Description
ENDODONTIC SURGERY
Primary Outcome Measure Information:
Title
Regeneration measured by tomographers endodontic surgery
Description
Six months after surgery, there were new scans to evaluate the repair or not the wounds.
Time Frame
Six months after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
patients were diagnosed by computed tomography CT, cone beam
each of them had from two to four compromised teeth
Exclusion Criteria:
patients who did not return for review after six months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniela Francescato Veiga
Organizational Affiliation
BRAZIL, UNIVAS
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
25714696
Citation
da Silva SR, da Silva Neto JD, Veiga DF, Schnaider TB, Ferreira LM. Portland cement versus MTA as a root-end filling material. A pilot study. Acta Cir Bras. 2015 Feb;30(2):160-4. doi: 10.1590/S0102-865020150020000011.
Results Reference
background
PubMed Identifier
23117614
Citation
Silva Neto JD, Schnaider TB, Gragnani A, Paiva AP, Novo NF, Ferreira LM. Portland cement with additives in the repair of furcation perforations in dogs. Acta Cir Bras. 2012 Nov;27(11):809-14. doi: 10.1590/s0102-86502012001100011.
Results Reference
result
PubMed Identifier
20443823
Citation
Feldman AM. Does academic culture support translational research? Clin Transl Sci. 2008 Sep;1(2):87-8. doi: 10.1111/j.1752-8062.2008.00046.x. No abstract available.
Results Reference
result
PubMed Identifier
21120277
Citation
Silva Neto JD, Brito RH, Schnaider TB, Gragnani A, Engelman M, Ferreira LM. Root perforations treatment using mineral trioxide aggregate and Portland cements. Acta Cir Bras. 2010 Dec;25(6):479-84. doi: 10.1590/s0102-86502010000600004.
Results Reference
result
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Applicability Clinic of Cement Portland Structural White in Endodontic Surgery
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