- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03491527
Influence of Resin Cement Composition on the Longevity of Intraradicular Post of Endodontically Treated Teeth
April 2, 2018 updated by: PAULO VINICIUS SOARES, Federal University of Uberlandia
Influence of Resin Cement Composition on the Longevity of Intraradicular Post in the Rehabilitation of Endodontically Treated Teeth - Randomized Clinical Trials
The aim of this study is through a randomized clinical trial, double blind, splithmouth, evaluate the success rate (post or dental crown displacement; fracture of the core/post/crown; marginal integrity and absence of endotontic alterations) of definitive indirect crowns un endodontically treated teeth.
The composition of the resin cement (with and without 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
Endodontically treated teeth present an increased risk of fracture and are usually related to extensive carious processes or trauma that promote major coronary destruction.
In such situations, it may be necessary to indicate intra-radicular retainers, such as fiberglass pins, to retain the restorative material.
The aim of this study is through a randomized clinical trial, double blind, splithmouth, evaluate the success rate (post or dental crown displacement; fracture of the core/post/crown; marginal integrity and absence of endotontic alterations) of definitive indirect crowns un endodontically treated teeth.
The composition of the resin cement (with and without mineral trioxide aggregate) will be evaluated.
Twenty participants with at least two teeth with endodontic treatment with need intraradicular post cementation and confection of indirect dental crown (each participant) will be selected.
The teeth will be randomly divided into 2 different groups according to resin cement composition (with and without 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
- Federal University of Uberlandia
-
-
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;
- Presence of at least two teeth with endodontc treatment;
- Presence of at least two teeth with indication of total crowns;
- Good oral hygiene.
Exclusion Criteria:
- Dentures or orthodontics;
- Presence of periodontal disease
- Presence of parafunctional habits
- Presence of systemic disease
- Constant use of analgesic and or anti-inflammatory
- 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: Conventional Resin Cement
Resin cement without MTA
|
Absolute isolation with rubber dam
Manipulation of the resin cement without MTA according to the manufacturer's recommendations.
Insertion of the cement on the root canal and on post surface.
Light-cured for 40 seconds on each surface.
Confection of a indirect crown prepare with diamand burs.
Dental impression whith silicone.
Insertion of the cement on the inner surface of the crown.
Light-cured for 40 seconds on each surface.
Analysis of the occlusion with carbon paper.
|
Active Comparator: MTA Resin Cement
Resin cement with MTA
|
Absolute isolation with rubber dam
Insertion of the cement on the root canal and on post surface.
Light-cured for 40 seconds on each surface.
Confection of a indirect crown prepare with diamand burs.
Dental impression whith silicone.
Insertion of the cement on the inner surface of the crown.
Light-cured for 40 seconds on each surface.
Analysis of the occlusion with carbon paper.
Manipulation of the resin cement with MTA according to the manufacturer's recommendations.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Success rate (post or dental crown displacement; fracture of the core/post/crown; marginal integrity and absence of endotontic alterations) of definitive indirect crowns with a 1 year follow up.
Time Frame: 1 year
|
1 year
|
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
- Assif D, Gorfil C. Biomechanical considerations in restoring endodontically treated teeth. J Prosthet Dent. 1994 Jun;71(6):565-7. doi: 10.1016/0022-3913(94)90438-3.
- Bahari M, Savadi Oskoee S, Kimyai S, Mohammadi N, Saati Khosroshahi E. Effect of Light Intensity on the Degree of Conversion of Dual-cured Resin Cement at Different Depths with the use of Translucent Fiber Posts. J Dent (Tehran). 2014 May;11(3):248-55. Epub 2014 May 31.
- Camilleri J, Montesin FE, Brady K, Sweeney R, Curtis RV, Ford TR. The constitution of mineral trioxide aggregate. Dent Mater. 2005 Apr;21(4):297-303. doi: 10.1016/j.dental.2004.05.010.
- Christensen GJ. Post concepts are changing. J Am Dent Assoc. 2004 Sep;135(9):1308-10. doi: 10.14219/jada.archive.2004.0406.
- Duarte MA, De Oliveira Demarchi AC, Yamashita JC, Kuga MC, De Campos Fraga S. Arsenic release provided by MTA and Portland cement. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2005 May;99(5):648-50. doi: 10.1016/j.tripleo.2004.09.015.
- Lee SJ, Monsef M, Torabinejad M. Sealing ability of a mineral trioxide aggregate for repair of lateral root perforations. J Endod. 1993 Nov;19(11):541-4. doi: 10.1016/S0099-2399(06)81282-3.
- Santos-Filho PC, Castro CG, Silva GR, Campos RE, Soares CJ. Effects of post system and length on the strain and fracture resistance of root filled bovine teeth. Int Endod J. 2008 Jun;41(6):493-501. doi: 10.1111/j.1365-2591.2008.01383.x. Epub 2008 Apr 12.
- von Arx T. [Mineral trioxide aggregate (MTA) a success story in apical surgery]. Swiss Dent J. 2016;126(6):573-95. French, German.
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)
May 1, 2018
Primary Completion (Anticipated)
September 30, 2018
Study Completion (Anticipated)
July 30, 2019
Study Registration Dates
First Submitted
April 2, 2018
First Submitted That Met QC Criteria
April 2, 2018
First Posted (Actual)
April 9, 2018
Study Record Updates
Last Update Posted (Actual)
April 9, 2018
Last Update Submitted That Met QC Criteria
April 2, 2018
Last Verified
April 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Stomatognathic Diseases
- Tooth Diseases
- Dental Pulp Diseases
- Tooth, Nonvital
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Antineoplastic Agents
- Dermatologic Agents
- Antifungal Agents
- Keratolytic Agents
- Folic Acid Antagonists
- Salicylic Acid
- Pemetrexed
Other Study ID Numbers
- 2.570.182
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.
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