Endodontically Treated TeethPhase 4NCT01520766
Prefabricated Endodontic Posts: Glass Fiber Versus Titanium - A Randomized Controlled Pilot- Trial
A Phase 4 study testing prefabricated titanium post and prefabricated glass fiber reinforced composite post in people with Endodontically Treated Teeth and Tooth Fractures, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endodontically Treated Teeth, Tooth Fractures
- What is being tested?
- prefabricated titanium post and prefabricated glass fiber reinforced composite post
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2003to Aug 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- tooth was aimed to serve as telescopic crown abutment
Trial locations and contacts
1 site in 1 country.
Germany1 site
Charité - Universitätsmedizin Berlin, CC3, Department of Prosthodontics, Geriatric Dentistry and Craniomandibular Disorders, Germany
Berlin, State of Berlin, 14197
About this study
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.
Read the 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.
- Conditions
- Endodontically Treated Teeth, Tooth Fractures
- Being tested
- prefabricated titanium post, prefabricated glass fiber reinforced composite post
- Keywords
- glass fiber posts, titanium posts, postendodontic restoration, self-adhesive resin cement
- Medical subject headings
- Tooth, Nonvital, Tooth Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prefabricated titanium postDevice
Also called Fiberpoints Root Pins Titanium, Schuetz Dental Group
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
prefabricated glass fiber reinforced composite postDevice
Also called Fiberpoints Roots Pins Glass, Schuetz Dental Group
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
| Study group | Role | What they receive |
|---|---|---|
| glass fiber | Experimental | Not described Receives: Device: prefabricated glass fiber reinforced composite post |
| titanium | Experimental | Not described Receives: Device: prefabricated titanium post |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 84 month after post placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2012 (estimated)
- Study startJan 2003
- Primary completionApr 2004
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Endodontically Treated TeethStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guido Sterzenbach, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01520766
- Sponsor's protocol ID
- CC3-7.103
- Status last verified
- Jan 2012
- First submitted
- 24 Jan 2012
- Last updated
- 31 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 17944340
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prefabricated Endodontic Posts: Glass Fiber Versus Titanium - A Randomized Controlled Pilot- Trial
- ClinicalTrials.gov ID
- NCT01520766
- Acronym / sponsor ID
- CC3-7.103
- Conditions
- Endodontically Treated Teeth, Tooth Fractures
- Keywords
- glass fiber posts, titanium posts, postendodontic restoration, self-adhesive resin cement
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Jan 2003
- Primary completion
- Apr 2004 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 30 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| glass fiber | Experimental | Device: prefabricated glass fiber reinforced composite post |
| titanium | Experimental | Device: prefabricated titanium post |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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,
Key exclusion criteria (1 listed)
- tooth was aimed to serve as telescopic crown abutment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| prefabricated titanium postAlso: Fiberpoints Root Pins Titanium, Schuetz Dental Groupposts: 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 | Device | titanium |
| prefabricated glass fiber reinforced composite postAlso: Fiberpoints Roots Pins Glass, Schuetz Dental Groupposts: 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 | Device | glass fiber |
Primary outcome
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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2012.
- Results publication: PubMed 17944340Naumann 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing prefabricated titanium post and prefabricated glass fiber reinforced composite post in people with Endodontically Treated Teeth and Tooth Fractures, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
loss of restoration for any reason (time frame: 84 months after post placement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01520766, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2012.