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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03491527
Other study ID # 2.570.182
Secondary ID
Status Not yet recruiting
Phase N/A
First received April 2, 2018
Last updated April 2, 2018
Start date May 1, 2018
Est. completion date July 30, 2019

Study information

Verified date April 2018
Source Federal University of Uberlandia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 20
Est. completion date July 30, 2019
Est. primary completion date September 30, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Procedure:
Absolute isolation
Absolute isolation with rubber dam
Manipulation of the resin cement with MTA
Manipulation of the resin cement with MTA according to the manufacturer's recommendations.
Manipulation of the resin cement without MTA
Manipulation of the resin cement without MTA according to the manufacturer's recommendations.
Fiber Post cimentation
Insertion of the cement on the root canal and on post surface. Light-cured for 40 seconds on each surface.
Dental Prepare
Confection of a indirect crown prepare with diamand burs.
Dental impression
Dental impression whith silicone.
Crown cimentation
Insertion of the cement on the inner surface of the crown. Light-cured for 40 seconds on each surface.
Occlusal adjustment
Analysis of the occlusion with carbon paper.

Locations

Country Name City State
Brazil Federal University of Uberlandia Uberlandia Minas Gerais

Sponsors (1)

Lead Sponsor Collaborator
Federal University of Uberlandia

Country where clinical trial is conducted

Brazil, 

References & Publications (8)

Assif D, Gorfil C. Biomechanical considerations in restoring endodontically treated teeth. J Prosthet Dent. 1994 Jun;71(6):565-7. — View Citation

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. — View Citation

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. — View Citation

Christensen GJ. Post concepts are changing. J Am Dent Assoc. 2004 Sep;135(9):1308-10. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

von Arx T. [Mineral trioxide aggregate (MTA) a success story in apical surgery]. Swiss Dent J. 2016;126(6):573-95. Review. French, German. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 1 year
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