Tooth, NonvitalNCT03466437
Post-retained Restorations for RPD Abutments
A study testing Glass-fiber post and composite resin restoration, Glass-fiber post and metalceramic crown and Cast-metal post and metalceramic crown in people with Tooth, Nonvital and Composite Resins, run by Federal University of Pelotas at 1 site in Brazil.
Trial summary
This study will be a controlled, randomized, parallel group trial where the survival rate of direct and indirect restorations on removable partial denture abutment teeth will be assessed. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tooth, Nonvital, Composite Resins, Metal Ceramic Restorations
- What is being tested?
- Glass-fiber post and composite resin restoration, Glass-fiber post and metalceramic crown and Cast-metal post and metalceramic crown
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteBrazil
- Study dates
- 28 Feb 2018to Feb 2021
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Individuals with good general and oral health;
- unilateral or bilateral free-end edentulism (Kennedy Classes I and II), which have adjacent abutments to edentulous space requiring endodontic treatment and at least 1 (one) remaining dentin wall and requiring intraradicular retention, with adequate bone support;
- minimum 18 years old;
- Knife-tipped alveolar ridges may be included in the study after trimming if the abovementioned criteria are met.
Who cannot join
- Untreated periodontal disease;
- poor oral hygiene;
- periapical lesion that does not respond to conventional endodontic treatment;
- abutment teeth with mobility greater than grade I;
- lack of prosthetic space due to extrusion of the opposing teeth;
- allergy to the materials used in the removable partial denture;
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- absence of occlusal contacts in the antagonist arch;
- patients who are participating in other clinical trials;
- patients who have complete denture opposing the site;
- financial restrictions;
- unable to be followed for a minimum period of 1 year
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Federal University of Pelotas - School of Dentistry
Pelotas, Rio Grande do Sul, 96015560
Tatiana Pereira-Cenci, PhD, +555332256741 ext. 134, tatiana.dds@ufpel.tche.br
Victório Poletto-Neto, MSc
About this study
Official title: Survival of Abutment Teeth of Removable Partial Dentures Rehabilitated With Post-retained Restorations: Randomized Clinical Trial
This study will be a controlled, randomized, parallel group trial where the survival rate of direct and indirect restorations on removable partial denture abutment teeth will be assessed. For this, individuals with widely destroyed teeth and need for endodontic treatment, with at least one remaining dentin wall, adjacent to edentulous spaces in Kennedy Classes I and II will be selected. After the minimum period of one year the teeth will be reassessed through clinical and radiographic examination annually.
All patients will receive oral hygiene instructions, caries disease control and endodontic treatment according to the need of each case. Prior to post cementation, patients will receive endodontic treatment through routine techniques that include use of rubber dam, mechanized instrumentation with NaOCl 2%, gutta percha and endodontic cement filling and condensation by the McSpadden technique. The preparation for post space will be done with a specific bur compatible with the diameter of root canal, and the same preparation cast post and cores. The glass-fiber posts (will be cleaned with 70% alcohol and receive silane application.
Read more
The clinical protocol for direct restoration and confection of the composite resin core will occur in the same way, using the same materials: the dental structure will be etched with 37% phosphoric acid and rinsed, followed by the adhesive system and fabrication of the restoration by incremental technique according to the manufacturer's recommendations. It is important to emphasize that the direct restorative procedure will be carried out in the same consultation of the glass-fiber post cementation.
In order to make the cast metal cores, the indirect impression technique will be done with prefabricated pins associated with addition silicone. In this technique, the lightweight material will be inserted into root canal and then, the pin will be introduced into the canal. Next, a prefabricated tray with the heavy and light material will be positioned for removal of the assembly, being removed after the setting time determined by the manufacturer. The mold obtained will be sent to the dental technician for cast post and core fabrication. All posts will be cemented under rubber-dam isolation using self-adhesive resin cement.
In teeth where randomization is a metalceramic crown, first the composite resin or metal core will be prepared with a 3216 drill, in order to obtain 1.5mm wear on the proximal and free faces and 2mm on the occlusal surface. The margin design in form of a chamfer, preferably at the gingival level whenever possible. The impression procedure will be carried out using a molding cap and polyether, which will be removed in a tray with irreversible hydrocolloid. A temporary crown will also be made for the patient. The metallic infrastructure will be tested in order to verify its adaptation and transferred in irreversible hydrocolloid molding for later ceramic application. After application of the ceramic, the laying and adaptation of the prosthetic piece will be conferred, being the crown luted with self-adhesive resin cement.
Once the restoration / crown of the abutment tooth has been made, the treatment will continue with the preparation of the removable partial denture. The teeth will always be prepared in the mesial proximal area. The delivery of the removable partial denture will be considered the baseline of the study. At this moment, the necessary adjustments and subsequent control of the prosthesis will be made after 24, 72 hours, a week and 15 days in order to check for possible flaws. After 6 months and 1 year of delivery of the removable partial denture, all patients will be recalled for clinical and radiographic evaluation of prostheses / restorations and oral hygiene conditions. This monitoring will be conducted by two evaluators until the end of the trial.
All clinical procedures will follow pre-established protocols and the data of each patient and intervention will be recorded in the individual patient file.
- Conditions
- Tooth, Nonvital, Composite Resins, Metal Ceramic Restorations, Denture, Partial, Removable, Post and Core Technique
- Being tested
- Glass-fiber post and composite resin restoration, Glass-fiber post and metalceramic crown, Cast-metal post and metalceramic crown
- Medical subject headings
- Tooth, Nonvital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glass-fiber post and composite resin restorationDevice
Patients will receive a glass-fiber and composite resin restoration followed by removable partial denture fabrication
Glass-fiber post and metalceramic crownDevice
Patients will receive a glass-fiber and metalceramic crown followed by removable partial denture fabrication
Cast-metal post and metalceramic crownDevice
Patients will receive a cast-metal post and metalceramic crown followed by removable partial denture fabrication
| Study group | Role | What they receive |
|---|---|---|
| Glass-fiber post + composite resin restoration | Experimental | Not described Receives: Device: Glass-fiber post and composite resin restoration |
| Glass-fiber post + metalceramic crown | Experimental | Not described Receives: Device: Glass-fiber post and metalceramic crown |
| Cast-metal post + metalceramic crown | Active comparator | Not described Receives: Device: Cast-metal post and metalceramic crown |
What is being measured
The primary outcome is the main question the study is designed to answer.
Direct Abutment Tooth Survival
Main outcome will be assessed considering loss (extraction) or maintenance of each restored tooth.
In order to simplify outcome measure, data for this outcome will be represented as "Tooth loss" (Yes or No)
Measured: Changes from baseline to 3 years of clinical function
Crown dislodgment
In any case that metalceramic crown moves from cemented position, this outcome will be assessed as: "Presence of Crown Dislodgment" (Yes or No)
Measured: Changes from baseline to 3 years of clinical function
Post debonding
In any case that post (glass-fiber or cast-metal post) debond from root canal, this outcome will be assessed as: "Presence of Post Debonding" (Yes or No)
Measured: Changes from baseline to 3 years of clinical function
Restoration Fracture
Described as any fracture of restorative material, this outcome will be assessed as: "Presence of Restoration Fracture" (Yes or No)
Measured: Changes from baseline to 3 years of clinical function
Post and core fracture
Clinical assessment of restored teeth will present data from this outcome as: "Presence of Post and Core Fracture" (Yes or No)
Measured: Changes from baseline to 3 years of clinical function
Root fracture
Clinical assessment of restored teeth will present data from this outcome as: "Presence of Root Fracture" (Yes or No)
Measured: Changes from baseline to 3 years of clinical function
Secondary caries
Clinical assessment of restored teeth will present data from this outcome as: "Presence of secondary caries" (Yes or No)
Measured: Changes from baseline to 3 years of clinical function
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2018
- Study start28 Feb 2018
- Primary completionFeb 2019 (estimated)
- Study completionFeb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth, NonvitalStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Pelotas
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maximiliano Sergio Cenci, Federal University of Pelotas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03466437
- Sponsor's protocol ID
- PPGO021
- Status last verified
- Apr 2018
- First submitted
- 28 Feb 2018
- Last updated
- 6 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survival of Abutment Teeth of Removable Partial Dentures Rehabilitated With Post-retained Restorations: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03466437
- Acronym / sponsor ID
- PPGO021
- Conditions
- Tooth, Nonvital, Composite Resins, Metal Ceramic Restorations, Denture, Partial, Removable, Post and Core Technique
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Federal University of PelotasUniversity, hospital or other
- Study start
- 28 Feb 2018 (actual)
- Primary completion
- Feb 2019 (estimated)
- Study completion
- Feb 2021 (estimated)
- First posted
- 15 Mar 2018 (actual)
- 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 study will be a controlled, randomized, parallel group trial where the survival rate of direct and indirect restorations on removable partial denture abutment teeth will be assessed. For this, individuals with widely destroyed teeth and need for endodontic treatment, with at least one remaining dentin wall, adjacent to edentulous spaces in Kennedy Classes I and II will be selected. After the minimum period of one year the teeth will be reassessed through clinical and radiographic examination annually.
All patients will receive oral hygiene instructions, caries disease control and endodontic treatment according to the need of each case. Prior to post cementation, patients will receive endodontic treatment through routine techniques that include use of rubber dam, mechanized instrumentation with NaOCl 2%, gutta percha and endodontic cement filling and condensation by the McSpadden technique. The preparation for post space will be done with a specific bur compatible with the diameter of root canal, and the same preparation cast post and cores. The glass-fiber posts (will be cleaned with 70% alcohol and receive silane application.
The clinical protocol for direct restoration and confection of the composite resin core will occur in the same way, using the same materials: the dental structure will be etched with 37% phosphoric acid and rinsed, followed by the adhesive system and fabrication of the restoration by incremental technique according to the manufacturer's recommendations. It is important to emphasize that the direct restorative procedure will be carried out in the same consultation of the glass-fiber post cementation.
In order to make the cast metal cores, the indirect impression technique will be done with prefabricated pins associated with addition silicone. In this technique, the lightweight material will be inserted into root canal and then, the pin will be introduced into the canal. Next, a prefabricated tray with the heavy and light material will be positioned for removal of the assembly, being removed after the setting time determined by the manufacturer. The mold obtained will be sent to the dental technician for cast post and core fabrication. All posts will be cemented under rubber-dam isolation using self-adhesive resin cement.
In teeth where randomization is a metalceramic crown, first the composite resin or metal core will be prepared with a 3216 drill, in order to obtain 1.5mm wear on the proximal and free faces and 2mm on the occlusal surface. The margin design in form of a chamfer, preferably at the gingival level whenever possible. The impression procedure will be carried out using a molding cap and polyether, which will be removed in a tray with irreversible hydrocolloid. A temporary crown will also be made for the patient. The metallic infrastructure will be tested in order to verify its adaptation and transferred in irreversible hydrocolloid molding for later ceramic application. After application of the ceramic, the laying and adaptation of the prosthetic piece will be conferred, being the crown luted with self-adhesive resin cement.
Once the restoration / crown of the abutment tooth has been made, the treatment will continue with the preparation of the removable partial denture. The teeth will always be prepared in the mesial proximal area. The delivery of the removable partial denture will be considered the baseline of the study. At this moment, the necessary adjustments and subsequent control of the prosthesis will be made after 24, 72 hours, a week and 15 days in order to check for possible flaws. After 6 months and 1 year of delivery of the removable partial denture, all patients will be recalled for clinical and radiographic evaluation of prostheses / restorations and oral hygiene conditions. This monitoring will be conducted by two evaluators until the end of the trial.
All clinical procedures will follow pre-established protocols and the data of each patient and intervention will be recorded in the individual patient file.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Glass-fiber post + composite resin restoration | Experimental | Device: Glass-fiber post and composite resin restoration |
| Glass-fiber post + metalceramic crown | Experimental | Device: Glass-fiber post and metalceramic crown |
| Cast-metal post + metalceramic crown | Active comparator | Device: Cast-metal post and metalceramic crown |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Individuals with good general and oral health;
- unilateral or bilateral free-end edentulism (Kennedy Classes I and II), which have adjacent abutments to edentulous space requiring endodontic treatment and at least 1 (one) remaining dentin wall and requiring intraradicular retention, with adequate bone support;
- minimum 18 years old;
- Knife-tipped alveolar ridges may be included in the study after trimming if the abovementioned criteria are met.
Key exclusion criteria (11 listed)
- Untreated periodontal disease;
- poor oral hygiene;
- periapical lesion that does not respond to conventional endodontic treatment;
- abutment teeth with mobility greater than grade I;
- lack of prosthetic space due to extrusion of the opposing teeth;
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 |
|---|---|---|
| Glass-fiber post and composite resin restorationPatients will receive a glass-fiber and composite resin restoration followed by removable partial denture fabrication | Device | Glass-fiber post + composite resin restoration |
| Glass-fiber post and metalceramic crownPatients will receive a glass-fiber and metalceramic crown followed by removable partial denture fabrication | Device | Glass-fiber post + metalceramic crown |
| Cast-metal post and metalceramic crownPatients will receive a cast-metal post and metalceramic crown followed by removable partial denture fabrication | Device | Cast-metal post + metalceramic crown |
Primary outcome
Direct Abutment Tooth Survival
Time frame: Changes from baseline to 3 years of clinical function
Main outcome will be assessed considering loss (extraction) or maintenance of each restored tooth. In order to simplify outcome measure, data for this outcome will be represented as "Tooth loss" (Yes or No)
Crown dislodgment
Time frame: Changes from baseline to 3 years of clinical function
In any case that metalceramic crown moves from cemented position, this outcome will be assessed as: "Presence of Crown Dislodgment" (Yes or No)
Post debonding
Time frame: Changes from baseline to 3 years of clinical function
In any case that post (glass-fiber or cast-metal post) debond from root canal, this outcome will be assessed as: "Presence of Post Debonding" (Yes or No)
Restoration Fracture
Time frame: Changes from baseline to 3 years of clinical function
Described as any fracture of restorative material, this outcome will be assessed as: "Presence of Restoration Fracture" (Yes or No)
Post and core fracture
Time frame: Changes from baseline to 3 years of clinical function
Clinical assessment of restored teeth will present data from this outcome as: "Presence of Post and Core Fracture" (Yes or No)
Root fracture
Time frame: Changes from baseline to 3 years of clinical function
Clinical assessment of restored teeth will present data from this outcome as: "Presence of Root Fracture" (Yes or No)
Secondary caries
Time frame: Changes from baseline to 3 years of clinical function
Clinical assessment of restored teeth will present data from this outcome as: "Presence of secondary caries" (Yes or No)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2018.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glass-fiber post and composite resin restoration, Glass-fiber post and metalceramic crown and Cast-metal post and metalceramic crown in people with Tooth, Nonvital and Composite Resins, 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 4 inclusion and 11 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 2018. 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.
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 (+55 5332256741 ext. 134, tatiana.dds@ufpel.tche.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Direct Abutment Tooth Survival (time frame: Changes from baseline to 3 years of clinical function). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2018; AzTrials last refreshed its copy on 27 Oct 2026.