NCT01520766

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
91

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2003

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2003

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2004

Completed
7.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 24, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 30, 2012

Completed
Last Updated

January 31, 2012

Status Verified

January 1, 2012

Enrollment Period

1.2 years

First QC Date

January 24, 2012

Last Update Submit

January 30, 2012

Conditions

Endodontically Treated TeethTooth Fractures

Keywords

glass fiber poststitanium postspostendodontic restorationself-adhesive resin cement

Outcome Measures

Primary Outcomes (1)

  • 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.

    84 months after post placement

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

    84 month after post placement

Study Arms (2)

glass fiber

EXPERIMENTAL
Device: prefabricated glass fiber reinforced composite post

titanium

EXPERIMENTAL
Device: prefabricated titanium post

Interventions

prefabricated titanium postDEVICE

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

Also known as: Fiberpoints Root Pins Titanium, Schuetz Dental Group
titanium
prefabricated glass fiber reinforced composite postDEVICE

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

Also known as: Fiberpoints Roots Pins Glass, Schuetz Dental Group
glass fiber

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • tooth was aimed to serve as telescopic crown abutment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Berlin, State of Berlin, 14197, Germany

Location

Related Publications (1)

  • 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.

    PMID: 17944340RESULT

MeSH Terms

Conditions

Tooth, NonvitalTooth Fractures

Condition Hierarchy (Ancestors)

Dental Pulp DiseasesTooth DiseasesStomatognathic DiseasesTooth InjuriesWounds and Injuries

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Dr. med. dent., Assistant Professor

Study Record Dates

First Submitted

January 24, 2012

First Posted

January 30, 2012

Study Start

January 1, 2003

Primary Completion

April 1, 2004

Study Completion

August 1, 2011

Last Updated

January 31, 2012

Record last verified: 2012-01

Locations

DE(1)