NCT03437629

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 11, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 19, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

March 30, 2018

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2018

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2018

Completed
Last Updated

February 19, 2018

Status Verified

February 1, 2018

Enrollment Period

Same day

First QC Date

February 11, 2018

Last Update Submit

February 16, 2018

Conditions

MTACalcium HydroxideDental Crown

Outcome Measures

Primary Outcomes (1)

  • Success rate (retention rate and absence of sensibility) of temporary dental crown cemented with different temporary cement with a 6 months follow up

    6 mounths

Study Arms (2)

Calcium Hydroxide temporary cement

ACTIVE COMPARATOR

Cementation of a temporary crown with cement based on calcium hydroxide.

Procedure: Temporary cement based on Calcium Hydroxide

MTA temporary cement

ACTIVE COMPARATOR

Cementation of a temporary crown with cement based on Mineral trioxide aggregate .

Procedure: MTA temporary cement

Interventions

Temporary cement based on Calcium HydroxidePROCEDURE

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.

Calcium Hydroxide temporary cement
MTA temporary cementPROCEDURE

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.

MTA temporary cement

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal University of Uberlandia

Uberlândia, Minas Gerais, 381440617, Brazil

RECRUITING

Related Publications (6)

  • Al Jabbari YS, Al-Rasheed A, Smith JW, Iacopino AM. An indirect technique for assuring simplicity and marginal integrity of provisional restorations during full mouth rehabilitation. Saudi Dent J. 2013 Jan;25(1):39-42. doi: 10.1016/j.sdentj.2012.10.003. Epub 2012 Nov 10.

    PMID: 23960554BACKGROUND

  • Arora SJ, Arora A, Upadhyaya V, Jain S. Comparative evaluation of marginal leakage of provisional crowns cemented with different temporary luting cements: In vitro study. J Indian Prosthodont Soc. 2016 Jan-Mar;16(1):42-8. doi: 10.4103/0972-4052.164911.

    PMID: 27134427BACKGROUND

  • da Rosa WLO, Cocco AR, Silva TMD, Mesquita LC, Galarca AD, Silva AFD, Piva E. Current trends and future perspectives of dental pulp capping materials: A systematic review. J Biomed Mater Res B Appl Biomater. 2018 Apr;106(3):1358-1368. doi: 10.1002/jbm.b.33934. Epub 2017 May 31.

    PMID: 28561919BACKGROUND

  • Hill EE, Lott J. A clinically focused discussion of luting materials. Aust Dent J. 2011 Jun;56 Suppl 1:67-76. doi: 10.1111/j.1834-7819.2010.01297.x.

    PMID: 21564117BACKGROUND

  • Malkoc MA, DemIr N, Sengun A, Bozkurt SB, Hakki SS. Cytotoxicity of temporary cements on bovine dental pulp-derived cells (bDPCs) using realtime cell analysis. J Adv Prosthodont. 2015 Feb;7(1):21-6. doi: 10.4047/jap.2015.7.1.21. Epub 2015 Feb 17.

    PMID: 25722833BACKGROUND

  • von Arx T. [Mineral trioxide aggregate (MTA) a success story in apical surgery]. Swiss Dent J. 2016;126(6):573-95. doi: 10.61872/sdj-2016-06-02. French, German.

    PMID: 27377433BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 11, 2018

First Posted

February 19, 2018

Study Start

March 30, 2018

Primary Completion

March 30, 2018

Study Completion

December 30, 2018

Last Updated

February 19, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)