Restoration SurvivalNCT01532947
Randomized Controlled Trial of Fiber Post Restorations
A study testing post placement in people with Restoration Survival, run by University of Siena.
Trial summary
This in vivo study examined the contribution of remaining coronal dentin and placement of a prefabricated or customized fiber post to the six-year survival of endodontically treated premolars. A sample of 345 patients provided 6 groups of 60 premolars in need of endodontic treatment. Read more about this study
- Who is it for?
- Ages 18 to 76 years
- Conditions the study is for
- Restoration Survival
- What is being tested?
- post placement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- No sites listed yet
- Study dates
- Jan 2003to Jun 2005
- Phase
- Interventional
- 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 to 76 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- endodontically treated premolars with symptom-free root canal filling and a minimum apical seal of 4 mm, in occlusal function with a natural tooth and in interproximal contact with two adjacent natural teeth.
Who cannot join
- periapical lesion on the X-ray.
About this study
Official title: Survival of Endodontically Treated and Restored Premolars: A Randomized Controlled Trial
This in vivo study examined the contribution of remaining coronal dentin and placement of a prefabricated or customized fiber post to the six-year survival of endodontically treated premolars. A sample of 345 patients provided 6 groups of 60 premolars in need of endodontic treatment. Groups were classified according to the number of remaining coronal walls before abutment build-up. Within each group, teeth were allocated to three subgroups: A) no post-retention; B) LP; C) ES (N=20). All teeth were protected with a crown. Cox regression analysis was applied to assess whether the amount of residual coronal dentin and the type of endocanalar retention had a significant influence on failure risk of the restored teeth.
- Conditions
- Restoration Survival
- Being tested
- post placement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
post placementProcedure or surgery
Also called Prefabricated post DT LightPost, RTD, Customized post, EverStick Post, StickTech
placement of an endocanalar post
| Study group | Role | What they receive |
|---|---|---|
| post restoration | Experimental | Not described Receives: Procedure: post placement |
| no post restoration | No intervention | no post placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
survival
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2012 (estimated)
- Study startJan 2003
- Primary completionJun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Restoration SurvivalStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Siena
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Marco Ferrari, University of Siena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01532947
- Sponsor's protocol ID
- RCTFP1
- Status last verified
- Feb 2012
- First submitted
- 5 Feb 2012
- Last updated
- 15 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Ferrari M, Sorrentino R, Juloski J, Grandini S, Carrabba M, Discepoli N, Ferrari Cagidiaco E. Post-Retained Single Crowns versus Fixed Dental Prostheses: A 7-Year Prospective Clinical Study. J Dent Res. 2017 Dec;96(13):1490-1497. doi: 10.1177/0022034517724146. Epub 2017 Aug 3.
PubMed 28771388Juloski J, Fadda GM, Monticelli F, Fajo-Pascual M, Goracci C, Ferrari M. Four-year Survival of Endodontically Treated Premolars Restored with Fiber Posts. J Dent Res. 2014 Jul;93(7 Suppl):52S-58S. doi: 10.1177/0022034514527970. Epub 2014 Mar 19.
PubMed 24646637Ferrari M, Vichi A, Fadda GM, Cagidiaco MC, Tay FR, Breschi L, Polimeni A, Goracci C. A randomized controlled trial of endodontically treated and restored premolars. J Dent Res. 2012 Jul;91(7 Suppl):72S-78S. doi: 10.1177/0022034512447949.
PubMed 22699672
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survival of Endodontically Treated and Restored Premolars: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01532947
- Acronym / sponsor ID
- RCTFP1
- Conditions
- Restoration Survival
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- University of SienaUniversity, hospital or other
- Study start
- Jan 2003
- Primary completion
- Jun 2005 (actual)
- First posted
- 15 Feb 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.
This in vivo study examined the contribution of remaining coronal dentin and placement of a prefabricated or customized fiber post to the six-year survival of endodontically treated premolars. A sample of 345 patients provided 6 groups of 60 premolars in need of endodontic treatment. Groups were classified according to the number of remaining coronal walls before abutment build-up. Within each group, teeth were allocated to three subgroups: A) no post-retention; B) LP; C) ES (N=20). All teeth were protected with a crown. Cox regression analysis was applied to assess whether the amount of residual coronal dentin and the type of endocanalar retention had a significant influence on failure risk of the restored teeth.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| post restoration | Experimental | Procedure: post placement |
| no post restoration | No intervention | –no post placement |
Who may qualify
- Ages
- 18 to 76 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- endodontically treated premolars with symptom-free root canal filling and a minimum apical seal of 4 mm, in occlusal function with a natural tooth and in interproximal contact with two adjacent natural teeth.
Key exclusion criteria (1 listed)
- periapical lesion on the X-ray.
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 |
|---|---|---|
| post placementAlso: Prefabricated post DT LightPost, RTD, Customized post, EverStick Post, StickTechplacement of an endocanalar post | Procedure or surgery | post restoration |
Primary outcome
survival
Time frame: 2 years
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 15 Feb 2012.
- Derived from this study: PubMed 28771388Ferrari M, Sorrentino R, Juloski J, Grandini S, Carrabba M, Discepoli N, Ferrari Cagidiaco E. Post-Retained Single Crowns versus Fixed Dental Prostheses: A 7-Year Prospective Clinical Study. J Dent Res. 2017 Dec;96(13):1490-1497. doi: 10.1177/0022034517724146. Epub 2017 Aug 3.
- Derived from this study: PubMed 24646637Juloski J, Fadda GM, Monticelli F, Fajo-Pascual M, Goracci C, Ferrari M. Four-year Survival of Endodontically Treated Premolars Restored with Fiber Posts. J Dent Res. 2014 Jul;93(7 Suppl):52S-58S. doi: 10.1177/0022034514527970. Epub 2014 Mar 19.
- Derived from this study: PubMed 22699672Ferrari M, Vichi A, Fadda GM, Cagidiaco MC, Tay FR, Breschi L, Polimeni A, Goracci C. A randomized controlled trial of endodontically treated and restored premolars. J Dent Res. 2012 Jul;91(7 Suppl):72S-78S. doi: 10.1177/0022034512447949.
Related trials for Restoration Survival
Recruiting
Evaluation of Ceramic Dental Crown Clinical Performance After Conventional Hydrofluoric Acid Etching or Gaseous Plasma Pretreatment
Prosthodontics, Dental Adhesives/Restorations Performance
Active, not recruiting
Clinical Comparison of Lithium Disilicate and 3D-Printed Resin Endocrowns
Endodontically Treated Teeth, Nonvital Teeth
Not yet recruiting
Clinical Evaluation of Different Bulk-Fill Restorative Materials in Primary Molars
Decayed Primary Molars, Decayed Tooth
Not yet recruiting
Evidence-Based Integrated Protocol to Maximize Hair Follicle Survival in Follicular Unit Extraction (FUE)
Androgenetic Alopecia, Cicatricial Alopecia
Not yet recruiting
3D-Printed Versus CAD/CAM-Milled Resin Restorations in Posterior Teeth.
Dental Restorations Longevity
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.
Questions about this trial
What is this clinical trial studying?
A study testing post placement in people with Restoration Survival, run by University of Siena.
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 1 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 15 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
survival (time frame: 2 years). 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 NCT01532947, which also lists 3 linked publications.
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 15 Feb 2012.