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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02474615
Other study ID # 14099
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received February 24, 2015
Last updated June 17, 2015
Start date February 2013
Est. completion date January 2015

Study information

Verified date June 2015
Source Universidade do Vale do Sapucai
Contact n/a
Is FDA regulated No
Health authority Brazil: National Committee of Ethics in Research
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Completed
Enrollment 12
Est. completion date January 2015
Est. primary completion date August 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 60 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
ENDODONTIC SURGERY
ENDODONTIC SURGERY

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Universidade do Vale do Sapucai

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Regeneration measured by tomographers endodontic surgery Six months after surgery, there were new scans to evaluate the repair or not the wounds. Six months after surgery Yes
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