Clinical trial NCT01520766: Prefabricated Endodontic Posts: Glass Fiber Versus Titanium - A Randomized Controlled Pilot- Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Endodontically Treated Teeth
Tooth Fractures
Keywords: glass fiber posts
titanium posts
postendodontic restoration
self-adhesive resin cement
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2012-01-30
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: loss of restoration for any reason
timeFrame: 84 months after post placement
Secondary outcomes:
measure: 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
timeFrame: 84 month after post placement
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin, CC3, Department of Prosthodontics, Geriatric Dentistry and Craniomandibular Disorders, Germany
Study officials:
References:
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.