Post and Core FailurePhase 3NCT01461239
Clinical Comparison of Endodontically Treated Teeth Restored With Fiber Posts or Cast Metal Posts
A Phase 3 study testing fiber post and resin core - self-adhesive cement, cast post and core and fiber post luted with conventional resin cement in people with Post and Core Failure, run by Federal University of Pelotas at 1 site in Brazil.
Trial summary
There are few randomized controlled trials comparing intraradicular posts used to restore endodontically treated teeth, especially considering cast posts and glass fiber posts. The investigators study will evaluate the clinical success rates of endodontically treated teeth restored with glass fiber posts or cast posts… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Post and Core Failure
- What is being tested?
- fiber post and resin core - self-adhesive cement, cast post and core and fiber post luted with conventional resin cement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2009to Jul 2018
- Phase
- Phase 3
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- adult patients with normal occlusion with at least one teeth endodontically treated needing restoration
Who cannot join
- patients with malocclusion,
- orthodontic devices,
- temporomandibular disorders
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
School of Dentistry - Federal University of Pelotas
Pelotas, Rio Grande do Sul, 96015560
Maximiliano S Cenci, PhD, +55 53 32226690 ext. 134, cencims@gmail.com
About this study
Official title: Randomized Clinical Comparison of Endodontically Treated Teeth Restored With Fiber Posts or Cast Metal Posts
There are few randomized controlled trials comparing intraradicular posts used to restore endodontically treated teeth, especially considering cast posts and glass fiber posts. The investigators study will evaluate the clinical success rates of endodontically treated teeth restored with glass fiber posts or cast posts and metal ceramic crown. Individuals included in this study should present any tooth with endodontic treatment and need of intraradicular retention (post) on maxilla or mandible according to inclusion and exclusion criteria. Individuals will be randomly allocated into two groups: (1) endodontically treated teeth restored with fiber post and composite resin core and metal ceramic crown or (2) endodontically treated teeth restored with cast post and core and metal ceramic crown. A sample size calculation will be performed to establish the number of posts needed for comparison. All crowns and posts will be cemented with self-adhesive cement. Individuals will be examined by calibrated examiners, in years 1 to 3. The reason of failure will be categorized as root fracture, fracture of the post, post debonding, clinical and/or radiographical evidence of a gap between restoration and tooth or endodontic failure, tooth extraction, secondary caries, or marginal defects. The confidence level will be set in 95%.
- Conditions
- Post and Core Failure
- Being tested
- fiber post and resin core - self-adhesive cement, cast post and core, fiber post luted with conventional resin cement
- Keywords
- survival, debonding, endodontic treated teeth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fiber post and resin core - self-adhesive cementProcedure or surgery
pre-fabricated glass fiber posts, cemented with self-adhesive resinous cement
cast post and coreProcedure or surgery
Ni-Cr alloy cast post and core luted with self-adhesive resin cement
fiber post luted with conventional resin cementProcedure or surgery
fiber post luted with conventional etch-and-rinse adhesive system and conventional resin cement, followed by core construction with composite resin
| Study group | Role | What they receive |
|---|---|---|
| cast post and core | Active comparator | Not described Receives: Procedure: cast post and core |
| fiber post - self-adhesive cement | Experimental | Not described Receives: Procedure: fiber post and resin core - self-adhesive cement |
| fiber post - conventional cement | Experimental | Not described Receives: Procedure: fiber post luted with conventional resin cement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post and core survival
Measured: 72 months
Secondary outcomes (3)
patient satisfaction with the treatment
Measured: 18 months
quality of crowns and restorations (FDI criteria)
Measured: 18 months
endodontic success
assessed by periapical radiographs for observation of apical lesion presence or absence
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2011 (estimated)
- Study startJul 2009
- Primary completionDec 2017 (estimated)
- Study completionJul 2018 (estimated)
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 Post and Core FailureStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Pelotas
- Sponsor type
- University, hospital or other
- Collaborators
- Universidade Federal de Santa Maria
- Responsible party
- Principal investigator, Maximiliano Sergio Cenci, Federal University of Pelotas
- Investigators
- Tatiana Pereira-Cenci, PhD, Principal investigator, Federal University of PelotasRogério Castilho Jacinto, PhD, Principal investigator, Federal University of Pelotas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01461239
- Sponsor's protocol ID
- UFPEL-PPGO0010
- Status last verified
- Apr 2017
- First submitted
- 5 Jul 2011
- Last updated
- 6 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Bergoli CD, Machry RV, Schwantz JK, Brondani LP, Pereira-Cenci T, Pereira GKR, Valandro LF. Survival rate and treatment success of glass fiber posts cemented with two adhesive cementation strategies after up to 106 months: a randomized clinical trial. Clin Oral Investig. 2023 May;27(5):2197-2206. doi: 10.1007/s00784-023-04939-x. Epub 2023 Mar 9.
PubMed 36894666Sarkis-Onofre R, Amaral Pinheiro H, Poletto-Neto V, Bergoli CD, Cenci MS, Pereira-Cenci T. Randomized controlled trial comparing glass fiber posts and cast metal posts. J Dent. 2020 May;96:103334. doi: 10.1016/j.jdent.2020.103334. Epub 2020 Apr 14.
PubMed 32302640Skupien JA, Cenci MS, Opdam NJ, Kreulen CM, Huysmans MC, Pereira-Cenci T. Crown vs. composite for post-retained restorations: A randomized clinical trial. J Dent. 2016 May;48:34-9. doi: 10.1016/j.jdent.2016.03.007. Epub 2016 Mar 11.
PubMed 26976553
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Comparison of Endodontically Treated Teeth Restored With Fiber Posts or Cast Metal Posts
- ClinicalTrials.gov ID
- NCT01461239
- Acronym / sponsor ID
- UFPEL-PPGO0010
- Conditions
- Post and Core Failure
- Keywords
- survival, debonding, endodontic treated teeth
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Federal University of PelotasUniversity, hospital or other
- Collaborators
- Universidade Federal de Santa Maria
- Study start
- Jul 2009
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 28 Oct 2011 (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.
There are few randomized controlled trials comparing intraradicular posts used to restore endodontically treated teeth, especially considering cast posts and glass fiber posts. The investigators study will evaluate the clinical success rates of endodontically treated teeth restored with glass fiber posts or cast posts and metal ceramic crown. Individuals included in this study should present any tooth with endodontic treatment and need of intraradicular retention (post) on maxilla or mandible according to inclusion and exclusion criteria. Individuals will be randomly allocated into two groups: (1) endodontically treated teeth restored with fiber post and composite resin core and metal ceramic crown or (2) endodontically treated teeth restored with cast post and core and metal ceramic crown. A sample size calculation will be performed to establish the number of posts needed for comparison. All crowns and posts will be cemented with self-adhesive cement. Individuals will be examined by calibrated examiners, in years 1 to 3. The reason of failure will be categorized as root fracture, fracture of the post, post debonding, clinical and/or radiographical evidence of a gap between restoration and tooth or endodontic failure, tooth extraction, secondary caries, or marginal defects. The confidence level will be set in 95%.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| cast post and core | Active comparator | Procedure: cast post and core |
| fiber post - self-adhesive cement | Experimental | Procedure: fiber post and resin core - self-adhesive cement |
| fiber post - conventional cement | Experimental | Procedure: fiber post luted with conventional resin cement |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- adult patients with normal occlusion with at least one teeth endodontically treated needing restoration
Key exclusion criteria (3 listed)
- patients with malocclusion,
- orthodontic devices,
- temporomandibular disorders
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 |
|---|---|---|
| fiber post and resin core - self-adhesive cementpre-fabricated glass fiber posts, cemented with self-adhesive resinous cement | Procedure or surgery | fiber post - self-adhesive cement |
| cast post and coreNi-Cr alloy cast post and core luted with self-adhesive resin cement | Procedure or surgery | cast post and core |
| fiber post luted with conventional resin cementfiber post luted with conventional etch-and-rinse adhesive system and conventional resin cement, followed by core construction with composite resin | Procedure or surgery | fiber post - conventional cement |
Primary outcome
Post and core survival
Time frame: 72 months
3 secondary outcomes
patient satisfaction with the treatment
Time frame: 18 months
quality of crowns and restorations (FDI criteria)
Time frame: 18 months
endodontic success
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2017.
- Derived from this study: PubMed 36894666Bergoli CD, Machry RV, Schwantz JK, Brondani LP, Pereira-Cenci T, Pereira GKR, Valandro LF. Survival rate and treatment success of glass fiber posts cemented with two adhesive cementation strategies after up to 106 months: a randomized clinical trial. Clin Oral Investig. 2023 May;27(5):2197-2206. doi: 10.1007/s00784-023-04939-x. Epub 2023 Mar 9.
- Derived from this study: PubMed 32302640Sarkis-Onofre R, Amaral Pinheiro H, Poletto-Neto V, Bergoli CD, Cenci MS, Pereira-Cenci T. Randomized controlled trial comparing glass fiber posts and cast metal posts. J Dent. 2020 May;96:103334. doi: 10.1016/j.jdent.2020.103334. Epub 2020 Apr 14.
- Derived from this study: PubMed 26976553Skupien JA, Cenci MS, Opdam NJ, Kreulen CM, Huysmans MC, Pereira-Cenci T. Crown vs. composite for post-retained restorations: A randomized clinical trial. J Dent. 2016 May;48:34-9. doi: 10.1016/j.jdent.2016.03.007. Epub 2016 Mar 11.
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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.
Tatiana Pereira-Cenci, PhD principal investigator
Federal University of Pelotas
Rogério Castilho Jacinto, PhD principal investigator
Federal University of Pelotas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing fiber post and resin core - self-adhesive cement, cast post and core and fiber post luted with conventional resin cement in people with Post and Core Failure, run by Federal University of Pelotas at 1 site in Brazil.
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 3 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: status not confirmed, as of the sponsor's last update on 6 Apr 2017. 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 Brazil. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tatiana Pereira-Cenci, PhD (+55 53 32226690, tatiana.dds@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post and core survival (time frame: 72 months). 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 NCT01461239, 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 6 Apr 2017.