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
  Purpose

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.


Condition Intervention Phase
Endodontically Treated Teeth
Tooth Fractures
Device: prefabricated titanium post
Device: prefabricated glass fiber reinforced composite post
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • 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.


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 [ 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.


Enrollment: 91
Study Start Date: January 2003
Study Completion Date: August 2011
Primary Completion Date: April 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: glass fiber 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
Experimental: titanium 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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01520766

Locations
Germany
Charité - Universitätsmedizin Berlin, CC3, Department of Prosthodontics, Geriatric Dentistry and Craniomandibular Disorders, Germany
Berlin, Germany, 14197
Sponsors and Collaborators
Charite University, Berlin, Germany
  More Information

Publications:
Responsible Party: Guido Sterzenbach, Principal Investigator, Dr. med. dent., Assistant Professor, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01520766     History of Changes
Other Study ID Numbers: CC3-7.103
Study First Received: January 24, 2012
Last Updated: January 30, 2012
Health Authority: Germany: Ethics Commission

Keywords provided by Charite University, Berlin, Germany:
glass fiber posts
titanium posts
postendodontic restoration
self-adhesive resin cement

Additional relevant MeSH terms:
Tooth Fractures
Tooth, Nonvital
Tooth Injuries
Tooth Diseases
Stomatognathic Diseases
Wounds and Injuries
Dental Pulp Diseases
Methamphetamine
Central Nervous System Stimulants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Dopamine Uptake Inhibitors

ClinicalTrials.gov processed this record on August 26, 2014