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Influences of Different Temporary Cement on Retention Rate of Temporary Crowns

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ClinicalTrials.gov Identifier: NCT03437629
Recruitment Status : Unknown
Verified February 2018 by PAULO VINICIUS SOARES, Federal University of Uberlandia.
Recruitment status was:  Recruiting
First Posted : February 19, 2018
Last Update Posted : February 19, 2018
Sponsor:
Information provided by (Responsible Party):
PAULO VINICIUS SOARES, Federal University of Uberlandia

Study Description
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Brief Summary:
The aim of this study is through a randomized clinical trial, double blind, split-mouth, evaluate the success rate (retention rate and dental sensibility) of temporary dental crown cemented on vital teeth. The composition of the cement (Based on calcium hydroxide; and based on mineral trioxide aggregate) will be evaluated. Data will be collected, tabulated and submitted to statistical analysis.

Condition or disease Intervention/treatment Phase
MTA Calcium Hydroxide Dental Crown Procedure: Temporary cement based on Calcium Hydroxide Procedure: MTA temporary cement Not Applicable

Detailed Description:
The confecction of temporary prosthesis is a fundamental step in the prosthetic process of definitive total crowns. The temporary cementation should provide sufficient retention between the intervals of the consultations, be biocompatible and not present high solubility. The aim of this study is through a randomized clinical trial, double blind, splithmouth, evaluate the success rate (retention rate and dental sensibility) of temporary dental crown cemented on vital teeth. The composition of the cement (Based on calcium hydroxide; and based on mineral trioxide aggregate) will be evaluated. Twenty participants with at least two vital teeth with the need to confection of definitive total crowns (each participant) will be selected who present. The teeth will be randomly divided into 2 different groups according to the temporary cement composition (Based on calcium hydroxide; and based on mineral trioxide aggregate). Data will be collected, tabulated and submitted to statistical analysis
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Influences of Different Temporary Cement on Retention Rate and Dental Sensitivity of Temporary Crown on Vital Teeth - Randomized Clinical Trial
Estimated Study Start Date : March 30, 2018
Estimated Primary Completion Date : March 30, 2018
Estimated Study Completion Date : December 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Calcium

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Calcium Hydroxide temporary cement
Cementation of a temporary crown with cement based on calcium hydroxide.
 Procedure: Temporary cement based on Calcium Hydroxide
Confection of a temporary crown with acrylic resin; Finishing and polishing; relative isolation with cotton and gauze; Manipulation of the temporary cement based on Calcium Hydroxide; Cement insertion on the internal surface of the temporary crown; Excess cement removal; Occlusal Adjustment.
Active Comparator: MTA temporary cement
Cementation of a temporary crown with cement based on Mineral trioxide aggregate .
 Procedure: MTA temporary cement
Confection of a temporary crown with acrylic resin; Finishing and polishing; relative isolation with cotton and gauze; Manipulation of the temporary cement based on Mineral trioxide aggregate; Cement insertion on the internal surface of the temporary crown; Excess cement removal; Occlusal Adjustment.


Outcome Measures
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Primary Outcome Measures :
  1. Success rate (retention rate and absence of sensibility) of temporary dental crown cemented with different temporary cement with a 6 months follow up [ Time Frame: 6 mounths ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Healthy volunteers; both genres; presence of at least two teeth with indication of total crowns; good oral hygiene.

Exclusion Criteria:

  • Dentures or orthodontics; presence of periodontal disease and,or parafunctional habits; systemic disease and, or severe psychological; constant use of analgesic and, or anti-inflammatory or allergic response to dental products.
Contacts and Locations
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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): NCT03437629


Locations
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Brazil
Federal University of Uberlandia Recruiting
Uberlandia, Minas Gerais, Brazil, 381440617
Contact: Paulo V Soares, DDS, MS, PHD    +55 34 991615642    paulovsoares@yahoo.com.br   
Contact: Alexandre C Machado, DDS, MS    +55 34 99133 5399    alexandrecoelhomachado@gmail.com   
Sponsors and Collaborators
Federal University of Uberlandia
More Information
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Publications:

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Responsible Party: PAULO VINICIUS SOARES, Professor, Federal University of Uberlandia
ClinicalTrials.gov Identifier: NCT03437629    
Other Study ID Numbers: 2.294.913
First Posted: February 19, 2018    Key Record Dates
Last Update Posted: February 19, 2018
Last Verified: February 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
Additional relevant MeSH terms:
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Calcium
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs