Prefabricated Endodontic Posts: Glass Fiber Versus Titanium - A Randomized Controlled Pilot- Trial
Primary Purpose
Endodontically Treated Teeth, Tooth Fractures
Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
prefabricated titanium post
prefabricated glass fiber reinforced composite post
Sponsored by
About this trial
This is an interventional treatment trial for Endodontically Treated Teeth focused on measuring glass fiber posts, titanium posts, postendodontic restoration, self-adhesive resin cement
Eligibility Criteria
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
Sites / Locations
- Charité - Universitätsmedizin Berlin, CC3, Department of Prosthodontics, Geriatric Dentistry and Craniomandibular Disorders, Germany
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
glass fiber
titanium
Arm Description
Outcomes
Primary Outcome Measures
loss of restoration for any reason
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.
Secondary Outcome Measures
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
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.
Full Information
NCT ID
NCT01520766
First Posted
January 24, 2012
Last Updated
January 30, 2012
Sponsor
Charite University, Berlin, Germany
1. Study Identification
Unique Protocol Identification Number
NCT01520766
Brief Title
Prefabricated Endodontic Posts: Glass Fiber Versus Titanium - A Randomized Controlled Pilot- Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
January 2003 (undefined)
Primary Completion Date
April 2004 (Actual)
Study Completion Date
August 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endodontically Treated Teeth, Tooth Fractures
Keywords
glass fiber posts, titanium posts, postendodontic restoration, self-adhesive resin cement
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
91 (Actual)
8. Arms, Groups, and Interventions
Arm Title
glass fiber
Arm Type
Experimental
Arm Title
titanium
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
prefabricated titanium post
Other Intervention Name(s)
Fiberpoints Root Pins Titanium, Schuetz Dental Group
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
prefabricated glass fiber reinforced composite post
Other Intervention Name(s)
Fiberpoints Roots Pins Glass, Schuetz Dental Group
Intervention Description
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
Primary Outcome Measure Information:
Title
loss of restoration for any reason
Description
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.
Time Frame
84 months after post placement
Secondary Outcome Measure Information:
Title
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
Description
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.
Time Frame
84 month after post placement
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Charité - Universitätsmedizin Berlin, CC3, Department of Prosthodontics, Geriatric Dentistry and Craniomandibular Disorders, Germany
City
Berlin
ZIP/Postal Code
14197
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
17944340
Citation
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.
Results Reference
result
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Prefabricated Endodontic Posts: Glass Fiber Versus Titanium - A Randomized Controlled Pilot- Trial
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