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Completed

NCT Number: NCT01520766

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

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.

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Key information

Conditions

Endodontically Treated Teeth Dental Pulp Diseases Stomatognathic Diseases Tooth Diseases Tooth Fractures Tooth Injuries Tooth, Nonvital Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Charité - Universitätsmedizin Berlin, CC3, Department of Prosthodontics, Geriatric Dentistry and Craniomandibular Disorders, Germany

Berlin, State of Berlin, 14197, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

prefabricated titanium post

Device

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 names: Fiberpoints Root Pins Titanium, Schuetz Dental Group

prefabricated glass fiber reinforced composite post

Device

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 names: Fiberpoints Roots Pins Glass, Schuetz Dental Group

Primary outcomes

  1. loss of restoration for any reason

    Time frame: 84 months after post placement

    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 outcomes

  1. 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

    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.

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Important dates

Study start
2003
Primary completion
2004
Study completion
2011
First posted
Jan 30, 2012
Registry last updated
Jan 31, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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