- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03437629
Influences of Different Temporary Cement on Retention Rate of Temporary Crowns
February 16, 2018 updated by: PAULO VINICIUS SOARES, Federal University of Uberlandia
Influences of Different Temporary Cement on Retention Rate and Dental Sensitivity of Temporary Crown on Vital Teeth - Randomized Clinical Trial
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Minas Gerais
-
Uberlandia, Minas Gerais, Brazil, 381440617
- Recruiting
- Federal University of Uberlandia
-
Contact:
- Paulo V Soares, DDS, MS, PHD
- Phone Number: +55 34 991615642
- Email: paulovsoares@yahoo.com.br
-
Contact:
- Alexandre C Machado, DDS, MS
- Phone Number: +55 34 99133 5399
- Email: alexandrecoelhomachado@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Calcium Hydroxide temporary cement
Cementation of a temporary crown with 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 .
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
6 mounths
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- von Arx T. [Mineral trioxide aggregate (MTA) a success story in apical surgery]. Swiss Dent J. 2016;126(6):573-95. French, German.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
March 30, 2018
Primary Completion (Anticipated)
March 30, 2018
Study Completion (Anticipated)
December 30, 2018
Study Registration Dates
First Submitted
February 11, 2018
First Submitted That Met QC Criteria
February 16, 2018
First Posted (Actual)
February 19, 2018
Study Record Updates
Last Update Posted (Actual)
February 19, 2018
Last Update Submitted That Met QC Criteria
February 16, 2018
Last Verified
February 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2.294.913
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on MTA
-
PAULO VINICIUS SOARESUnknownMTA | Calcium Hydroxide | Endodontic TreatmentBrazil
-
Universitat Internacional de CatalunyaUnknownEvaluate the Effects of MEDCEM PC and MTA in Pulpotomies of Primary Molars.Spain
-
Federal University of UberlandiaUnknownMTA | Dental Restoration, TemporaryBrazil
-
Hadassah Medical OrganizationCompletedPulpotomies Primary Teeth | Effectiveness of MedCem MTA® in Pulpotomies Primary TeethIsrael
-
Federal University of UberlandiaUnknownEndodontically Treated Teeth | MTA | Resin CementBrazil
-
University of LiverpoolLiverpool University Hospitals NHS Foundation TrustCompletedPeriapical Periodontitis | Apexification | Pulp Necrosis | MTA | Apexogenesis | Pulp Revascularisation | Non-vital Immature ToothUnited Kingdom
Clinical Trials on Temporary cement based on Calcium Hydroxide
-
PAULO VINICIUS SOARESUnknownMTA | Calcium Hydroxide | Endodontic TreatmentBrazil
-
University of BirminghamShirley Glasstone Hughes Trust FundUnknownDental Caries | Post-operative PainUnited Kingdom
-
University of Medicine and Pharmacy at Ho Chi Minh...CompletedPain, Postoperative | Pulpitis - IrreversibleVietnam
-
Azad University of Medical SciencesUnknownDental Pulp NecrosisIran, Islamic Republic of
-
Ataturk UniversityCompletedPeriapical; InfectionTurkey
-
Altinbas UniversityIstanbul UniversityCompleted
-
Afyonkarahisar Health Sciences UniversityNot yet recruitingDental Enamel HypomineralizationTurkey
-
Federal University of UberlandiaUnknownMTA | Dental Restoration, TemporaryBrazil
-
Purdue UniversityNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Completed
-
University of Illinois at ChicagoCompleted