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Post-retained Restorations for RPD Abutments

Primary Purpose

Tooth, Nonvital, Composite Resins, Metal Ceramic Restorations

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Glass-fiber post and composite resin restoration
Glass-fiber post and metalceramic crown
Cast-metal post and metalceramic crown
Sponsored by
Federal University of Pelotas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tooth, Nonvital

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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;
  • 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

Sites / Locations

  • Federal University of Pelotas - School of DentistryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Glass-fiber post + composite resin restoration

Glass-fiber post + metalceramic crown

Cast-metal post + metalceramic crown

Arm Description

Outcomes

Primary Outcome Measures

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)
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)
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)
Restoration Fracture
Described as any fracture of restorative material, this outcome will be assessed as: "Presence of Restoration Fracture" (Yes or No)
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)
Root fracture
Clinical assessment of restored teeth will present data from this outcome as: "Presence of Root Fracture" (Yes or No)
Secondary caries
Clinical assessment of restored teeth will present data from this outcome as: "Presence of secondary caries" (Yes or No)

Secondary Outcome Measures

Full Information

First Posted
February 28, 2018
Last Updated
April 5, 2018
Sponsor
Federal University of Pelotas
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1. Study Identification

Unique Protocol Identification Number
NCT03466437
Brief Title
Post-retained Restorations for RPD Abutments
Official Title
Survival of Abutment Teeth of Removable Partial Dentures Rehabilitated With Post-retained Restorations: Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
February 28, 2018 (Actual)
Primary Completion Date
February 2019 (Anticipated)
Study Completion Date
February 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Pelotas

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tooth, Nonvital, Composite Resins, Metal Ceramic Restorations, Denture, Partial, Removable, Post and Core Technique

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
105 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Glass-fiber post + composite resin restoration
Arm Type
Experimental
Arm Title
Glass-fiber post + metalceramic crown
Arm Type
Experimental
Arm Title
Cast-metal post + metalceramic crown
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Glass-fiber post and composite resin restoration
Intervention Description
Patients will receive a glass-fiber and composite resin restoration followed by removable partial denture fabrication
Intervention Type
Device
Intervention Name(s)
Glass-fiber post and metalceramic crown
Intervention Description
Patients will receive a glass-fiber and metalceramic crown followed by removable partial denture fabrication
Intervention Type
Device
Intervention Name(s)
Cast-metal post and metalceramic crown
Intervention Description
Patients will receive a cast-metal post and metalceramic crown followed by removable partial denture fabrication
Primary Outcome Measure Information:
Title
Direct Abutment Tooth Survival
Description
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)
Time Frame
Changes from baseline to 3 years of clinical function
Title
Crown dislodgment
Description
In any case that metalceramic crown moves from cemented position, this outcome will be assessed as: "Presence of Crown Dislodgment" (Yes or No)
Time Frame
Changes from baseline to 3 years of clinical function
Title
Post debonding
Description
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)
Time Frame
Changes from baseline to 3 years of clinical function
Title
Restoration Fracture
Description
Described as any fracture of restorative material, this outcome will be assessed as: "Presence of Restoration Fracture" (Yes or No)
Time Frame
Changes from baseline to 3 years of clinical function
Title
Post and core fracture
Description
Clinical assessment of restored teeth will present data from this outcome as: "Presence of Post and Core Fracture" (Yes or No)
Time Frame
Changes from baseline to 3 years of clinical function
Title
Root fracture
Description
Clinical assessment of restored teeth will present data from this outcome as: "Presence of Root Fracture" (Yes or No)
Time Frame
Changes from baseline to 3 years of clinical function
Title
Secondary caries
Description
Clinical assessment of restored teeth will present data from this outcome as: "Presence of secondary caries" (Yes or No)
Time Frame
Changes from baseline to 3 years of clinical function

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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; 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tatiana Pereira-Cenci
Phone
+55 5332256741
Ext
134
Email
tatiana.dds@ufpel.tche.br
First Name & Middle Initial & Last Name or Official Title & Degree
Victório Poletto Neto
Phone
+55 53981009331
Email
polettonetov@gmail.com
Facility Information:
Facility Name
Federal University of Pelotas - School of Dentistry
City
Pelotas
State/Province
RS
ZIP/Postal Code
96015560
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tatiana Pereira-Cenci, PhD
Phone
+555332256741
Ext
134
Email
tatiana.dds@ufpel.tche.br
First Name & Middle Initial & Last Name & Degree
Victório Poletto-Neto, MSc
First Name & Middle Initial & Last Name & Degree
Tatiana Pereira-Cenci, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Post-retained Restorations for RPD Abutments

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