Prefabricated Endodontic Posts: Glass Fiber Versus Titanium - A Randomized Controlled Pilot- Trial

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Guido Sterzenbach, Charite University, Berlin, Germany

ClinicalTrials.gov Identifier:

NCT01520766

First received: January 24, 2012

Last updated: January 30, 2012

Last verified: January 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	January 24, 2012
Last Updated Date	January 30, 2012
Start Date ^ICMJE	January 2003
Primary Completion Date	April 2004 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: January 26, 2012)	loss of restoration for any reason [ Time Frame: 84 months after post placement ] [ Designated as safety issue: No ] The patients were recalled at 3, 6, 12 month and thereafter in al yearly recall up to 84 month after post placement for clinical examination. The clinical examination was performed by one blinded dentist.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01520766 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: January 26, 2012)	tooth loss, post debonding, post fracture, vertical or horizontal root fracture, endodontic or periradicular conditions requiring endodontic re-treatment, secondary caries and failure of core build-up and loss of restoration due to technical failures [ Time Frame: 84 month after post placement ] [ Designated as safety issue: No ] The clinical examination was performed by one blinded dentist. Follow-up examinations were performed with a dental probe to detect marginal gap formation of restorations. After 12 and 60 months radiographs were taken and examined by one operator (MN) to exclude the possibility of radiographic symptoms of failure, e.g. periodontal or periapical lesions.
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Prefabricated Endodontic Posts: Glass Fiber Versus Titanium - A Randomized Controlled Pilot- Trial
Official Title ^ICMJE	Not Provided
Brief Summary	A randomized parallel-group clinical pilot study was designed to evaluate the impact of glass fiber reinforced composite posts compared to prefabricated titanium posts on long term survival of adhesively restored endodontically treated abutment teeth.
Detailed Description	Compared to vital teeth the complication rate of restorations fixed on endodontically treated abutment teeth is higher. Endodontically treated teeth are more prone to fracture due to the higher amount of calcified tooth structure loss. To level the biological short coming the choice of the mechanically appropriate post material is still a major concern. There a two major approaches. One is to use a rigid material to stiffen the post-endodontic complex and the other is to use a material which shows dentin-like material properties to allow the post-endodontic complex to flex under load. It was aim of the presented randomised controlled trial to compare the survival rates of abutment teeth self-adhesively restored with either prefabricated glass-fiber reinforced composite posts or titanium posts. The null-hypothesis was that there is no difference regarding survival rate between glass-fiber and titanium post restored endodontically treated abutment teeth with two or less remaining cavity walls.
Study Type ^ICMJE	Interventional
Study Phase	Phase 4
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Endodontically Treated Teeth Tooth Fractures
Intervention ^ICMJE	Device: prefabricated titanium post posts: diameter of 1.4 mm; length of 13 mm adhesively luted within the root canal using self-adhesive resin cement and direct composite cores using an etch-and-rinse adhesive were built up crown preparation was performed, while the finishing line for the final restoration was set at least 2 mm apical the composite build-up in dentin to ensure a proper dentin ferrule design Other Name: Fiberpoints Root Pins Titanium, Schuetz Dental Group Device: prefabricated glass fiber reinforced composite post posts: diameter of 1.4 mm; length of 13 mm adhesively luted within the root canal using self-adhesive resin cement and direct composite cores using an etch-and-rinse adhesive were built up crown preparation was performed, while the finishing line for the final restoration was set at least 2 mm apical the composite build-up in dentin to ensure a proper dentin ferrule design Other Name: Fiberpoints Roots Pins Glass, Schuetz Dental Group
Study Arm (s)	Experimental: glass fiber Intervention: Device: prefabricated glass fiber reinforced composite post Experimental: titanium Intervention: Device: prefabricated titanium post
Publications *	Naumann M, Sterzenbac G, Alexandra F, Dietrich T. Randomized controlled clinical pilot trial of titanium vs. glass fiber prefabricated posts: preliminary results after up to 3 years. Int J Prosthodont. 2007 Sep-Oct;20(5):499-503.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	91
Completion Date	August 2011
Primary Completion Date	April 2004 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: two or less cavity walls of the crown remaining, residual root canal thickness at the orifice of more than 1 mm, symptom free tooth with a root canal filling without radiologically visible periapical lesion, minimum of radiologic root-to-alveolar bone ratio of 2 after prospective crown lengthening, no or treated periodontitis with maximum probing depth of 4 mm and no bleeding on probing, tooth mobility not more than score II, willingness to return for follow-up examination for at least 5 years Exclusion Criteria: tooth was aimed to serve as telescopic crown abutment
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Germany

Administrative Information
NCT Number ^ICMJE	NCT01520766
Other Study ID Numbers ^ICMJE	CC3-7.103
Has Data Monitoring Committee	No
Responsible Party	Guido Sterzenbach, Charite University, Berlin, Germany
Study Sponsor ^ICMJE	Charite University, Berlin, Germany
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Charite University, Berlin, Germany
Verification Date	January 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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