Partial EdentulismPhase 2NCT00223431
Clinical Performance of 3-Unit FPDs
A Phase 2 study testing all-ceramic fixed partial denture in people with Partial Edentulism, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial summary
Objectives: The purpose of this research was to determine the clinical success rate of a lithia-disilicate-based core ceramic (Ivoclar, Vivadent Corp.) for use in posterior fixed partial dentures (FPDs) as a function of bite force, cement type, connector height, and connector width. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Partial Edentulism
- What is being tested?
- all-ceramic fixed partial denture
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 1998to May 2004
- Phase
- Phase 2
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- missing posterior tooth in a quadrant (first premolars through second molars) that could be restored with a 3-unit FPD
- periodontal pockets of less than 4 mm for each abutment with no periodontal disease
- vital abutment teeth
- crown root ratio of at least 1:1.
Who cannot join
- individuals with medical contraindications to dental treatment
- parafunctional habits
- inability to ensure residence in the area for the next five years
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Florida College of Dentistry
Gainesville, Florida, 32610
About this study
Official title: Clinical Performance of Three-Unit Fixed Partial Dentures (FPDs) Made From a Hot-Pressed Ceramic (Five-Year Study)
Objectives: The purpose of this research was to determine the clinical success rate of a lithia-disilicate-based core ceramic (Ivoclar, Vivadent Corp.) for use in posterior fixed partial dentures (FPDs) as a function of bite force, cement type, connector height, and connector width.
Methods: Thirty ceramic FPD core frameworks were prepared using a hot-pressing technique and a lithia-disilicate-based core ceramic. The maximum clenching force was measured for each patient prior to tooth preparation. Connector heights and widths were measured for each FPD. Patients were recalled yearly after cementation for two years and evaluated using eleven clinical criteria. All FPDs were examined by two independent clinicians and rankings for each criterion were made from 1 to 4 with 4 = excellent and 1 = unacceptable.
Read more
The aims of this research were:
- To test the hypotheses that three-unit fixed partial dentures (FPDs) of a high-strength core ceramic will exhibit good-to-excellent clinical performance (based on 11 evaluative criteria) and that they will adequately resist fracture in posterior situations (excluding third molars) if fabricated with the minimal connector size (4 mm x 4 mm).
- To test the hypothesis that a reinforced glass ionomer cement (ProTec CEM, Ivoclar, Vivadent), when used to cement core ceramic crowns in posterior FPDs, will be associated with significantly less marginal quality, but similar fracture resistance of the ceramic crowns compared with the marginal quality associated with a dual cure resin cement (Variolink® II, Ivoclar Vivadent AG, Schaan, Liechtenstein).
- To test the hypothesis that there is no significant difference in tooth sensitivity associated with FPDs cemented with the glass ionomer cement and dual-cure resin cement.
Read the detailed description
All patient recruitment and treatment were performed at the University of Florida College of Dentistry, Graduate Prosthodontic Clinic by Prosthodontic faculty. Patients were initially screened to exclude individuals with medical contraindications to dental treatment, parafunctional habits, and inability to ensure residence in the area for the next five years. Inclusion criteria were a missing posterior tooth in a quadrant (first premolars through second molars) that could be restored with a 3-unit FPD, periodontal pockets of less than 4 mm for each abutment with no periodontal disease, vital abutment teeth, and a crown root ratio of at least 1:1. A patient can have multiple FPDs placed as long as the above-mentioned criteria were met. Baseline data were obtained for each selected subject to include the following:
- General medical history and physical examination
- Primary casts made with irreversible hydrocolloid impression material
- Bite force measurement in Newtons made with a gnathodynamometer
- Pocket depths of abutment teeth
- Periapical radiographs of abutment teeth. The maximum occlusal force exerted by each subject was measured prior to commencing treatment using a bite force gauge that has been reported previously by Gibbs et al.12 The purpose of these measurements was to analyze the influence of occlusal force on the survival of the FPDs. A total of 30 FPDs were fabricated for 21 patients with the core ceramic and all patients were recalled each year for two years. Three clinicians performed treatment and one technician using an in-house laboratory accomplished all labwork. Out of the 21 patients, 18 were female and 3 were male with ages ranging from 30 to 62 years of age. The 3-unit FPDs were located in the posterior area with canines serving as the most anterior abutment and second molars as the most posterior abutment. All FPDs were opposed by natural dentition. The dimensions for tooth reduction included at least 1 mm of axial reduction; 2 mm of occlusal reduction and incorporation of a shoulder or a deep chamfer margin design with rounded line angles. Final impressions were made using a dual impression technique with high and low viscosity polyvinylsiloxane in a stock tray. Provisional resin FPDs were made and cemented with temporary cement. FPDs were processed by hot-pressing the core ceramic (Ivoclar Vivadent AG, Schaan, Liechtenstein) and applying stain and glaze as necessary. The heat-pressed ceramic system uses the lost wax technique whereby the FPD is waxed to its proper shape and contour and then invested in a special flask with a special type of investment material. The desired shade of a precerammed ceramic cylinder is plasticized at 1100oC and pressed under vacuum and pressure into the mold of the investment.13 The ceramic FPDs were inspected to ensure that the incisogingival height and curvature of the gingival embrasure of the connectors were adequate to resist fracture when subjected to normal biting forces. The minimal dimensions recommended for premolar FPDs, 4 mm x 4 mm, and for molar FPDs, 4 mm x 5 mm, were applied for each FPD when esthetics and gingival contour permitted. Connector heights and widths were measured for each FPD using a boley gauge. FPDs were cemented using either a resin-reinforced glass ionomer cement (Protec CEM, Vivadent) or a dual-cure resin cement (Variolink II, Vivadent) using a random number table. Fourteen (14) FPDs were cemented with the resin-reinforced glass ionomer and 13 with the dual cure resin. Patients were recalled after cementation annually for two years and evaluated for the following clinical criteria: (1) tissue health; (2) secondary caries; (3) occlusion; (4) proximal contact; (5) marginal integrity; (6) absence of sensitivity to percussion, heat, cold, and air; (7) color match; (8) surface texture; (9) absence of wear of opposing teeth; (10) anatomic contour; and (11) no cracks/chips or fracture. This evaluative system was derived from the California Dental Association quality assessment evaluation system.14 FPDs were examined by two independent clinicians who did not prepare the teeth or cement the prosthesis, and rankings of each criterion were made from 1 to 4 with 4 = excellent, 3 = good, 2 = unacceptable (needs repair or replacement in the near future), and 1 = unacceptable (needs immediate replacement). All clinicians/evaluators were subjected to several calibration exercises that consisted of table top analysis of marginal openings as well as slide evaluations of different clinical situations.
Data were analyzed by logistic regression analysis of the variables with α = 0.05. The consistency of the examiners' scores was evaluated for consistency using a test for the standard deviation of inter-examination.
- Conditions
- Partial Edentulism
- Being tested
- all-ceramic fixed partial denture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
all-ceramic fixed partial dentureDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical performance
improved esthetics
improved occlusal function of a lithia disilicate based core ceramic. Performance was measured yearly for 4 years.
Secondary outcomes (1)
wear of opposing enamel
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startFeb 1998
- Study completionMay 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Partial EdentulismStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center at San Antonio
- Sponsor type
- University, hospital or other
- Collaborators
- Ivoclar Vivadent AG
- Investigators
- Kenneth J Anusavice, PhD, DMD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00223431
- Sponsor's protocol ID
- 114-1998
- Status last verified
- Sep 2005
- First submitted
- 13 Sep 2005
- Last updated
- 22 Sep 2005
- Results posted
- No
Publications
Esquivel-Upshaw JF, Anusavice KJ, Young H, Jones J, Gibbs C. Clinical performance of a lithia disilicate-based core ceramic for three-unit posterior FPDs. Int J Prosthodont. 2004 Jul-Aug;17(4):469-75.
PubMed 15382785Gibbs CH, Anusavice KJ, Young HM, Jones JS, Esquivel-Upshaw JF. Maximum clenching force of patients with moderate loss of posterior tooth support: a pilot study. J Prosthet Dent. 2002 Nov;88(5):498-502. doi: 10.1067/mpr.2002.129062.
PubMed 12473999
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance of Three-Unit Fixed Partial Dentures (FPDs) Made From a Hot-Pressed Ceramic (Five-Year Study)
- ClinicalTrials.gov ID
- NCT00223431
- Acronym / sponsor ID
- 114-1998
- Conditions
- Partial Edentulism
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Collaborators
- Ivoclar Vivadent AG
- Study start
- Feb 1998
- Study completion
- May 2004
- First posted
- 22 Sep 2005 (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.
Objectives: The purpose of this research was to determine the clinical success rate of a lithia-disilicate-based core ceramic (Ivoclar, Vivadent Corp.) for use in posterior fixed partial dentures (FPDs) as a function of bite force, cement type, connector height, and connector width.
Methods: Thirty ceramic FPD core frameworks were prepared using a hot-pressing technique and a lithia-disilicate-based core ceramic. The maximum clenching force was measured for each patient prior to tooth preparation. Connector heights and widths were measured for each FPD. Patients were recalled yearly after cementation for two years and evaluated using eleven clinical criteria. All FPDs were examined by two independent clinicians and rankings for each criterion were made from 1 to 4 with 4 = excellent and 1 = unacceptable.
The aims of this research were:
- To test the hypotheses that three-unit fixed partial dentures (FPDs) of a high-strength core ceramic will exhibit good-to-excellent clinical performance (based on 11 evaluative criteria) and that they will adequately resist fracture in posterior situations (excluding third molars) if fabricated with the minimal connector size (4 mm x 4 mm).
- To test the hypothesis that a reinforced glass ionomer cement (ProTec CEM, Ivoclar, Vivadent), when used to cement core ceramic crowns in posterior FPDs, will be associated with significantly less marginal quality, but similar fracture resistance of the ceramic crowns compared with the marginal quality associated with a dual cure resin cement (Variolink® II, Ivoclar Vivadent AG, Schaan, Liechtenstein).
- To test the hypothesis that there is no significant difference in tooth sensitivity associated with FPDs cemented with the glass ionomer cement and dual-cure resin cement.
Detailed description
All patient recruitment and treatment were performed at the University of Florida College of Dentistry, Graduate Prosthodontic Clinic by Prosthodontic faculty. Patients were initially screened to exclude individuals with medical contraindications to dental treatment, parafunctional habits, and inability to ensure residence in the area for the next five years. Inclusion criteria were a missing posterior tooth in a quadrant (first premolars through second molars) that could be restored with a 3-unit FPD, periodontal pockets of less than 4 mm for each abutment with no periodontal disease, vital abutment teeth, and a crown root ratio of at least 1:1. A patient can have multiple FPDs placed as long as the above-mentioned criteria were met. Baseline data were obtained for each selected subject to include the following:
- General medical history and physical examination
- Primary casts made with irreversible hydrocolloid impression material
- Bite force measurement in Newtons made with a gnathodynamometer
- Pocket depths of abutment teeth
- Periapical radiographs of abutment teeth. The maximum occlusal force exerted by each subject was measured prior to commencing treatment using a bite force gauge that has been reported previously by Gibbs et al.12 The purpose of these measurements was to analyze the influence of occlusal force on the survival of the FPDs. A total of 30 FPDs were fabricated for 21 patients with the core ceramic and all patients were recalled each year for two years. Three clinicians performed treatment and one technician using an in-house laboratory accomplished all labwork. Out of the 21 patients, 18 were female and 3 were male with ages ranging from 30 to 62 years of age. The 3-unit FPDs were located in the posterior area with canines serving as the most anterior abutment and second molars as the most posterior abutment. All FPDs were opposed by natural dentition. The dimensions for tooth reduction included at least 1 mm of axial reduction; 2 mm of occlusal reduction and incorporation of a shoulder or a deep chamfer margin design with rounded line angles. Final impressions were made using a dual impression technique with high and low viscosity polyvinylsiloxane in a stock tray. Provisional resin FPDs were made and cemented with temporary cement. FPDs were processed by hot-pressing the core ceramic (Ivoclar Vivadent AG, Schaan, Liechtenstein) and applying stain and glaze as necessary. The heat-pressed ceramic system uses the lost wax technique whereby the FPD is waxed to its proper shape and contour and then invested in a special flask with a special type of investment material. The desired shade of a precerammed ceramic cylinder is plasticized at 1100oC and pressed under vacuum and pressure into the mold of the investment.13 The ceramic FPDs were inspected to ensure that the incisogingival height and curvature of the gingival embrasure of the connectors were adequate to resist fracture when subjected to normal biting forces. The minimal dimensions recommended for premolar FPDs, 4 mm x 4 mm, and for molar FPDs, 4 mm x 5 mm, were applied for each FPD when esthetics and gingival contour permitted. Connector heights and widths were measured for each FPD using a boley gauge. FPDs were cemented using either a resin-reinforced glass ionomer cement (Protec CEM, Vivadent) or a dual-cure resin cement (Variolink II, Vivadent) using a random number table. Fourteen (14) FPDs were cemented with the resin-reinforced glass ionomer and 13 with the dual cure resin. Patients were recalled after cementation annually for two years and evaluated for the following clinical criteria: (1) tissue health; (2) secondary caries; (3) occlusion; (4) proximal contact; (5) marginal integrity; (6) absence of sensitivity to percussion, heat, cold, and air; (7) color match; (8) surface texture; (9) absence of wear of opposing teeth; (10) anatomic contour; and (11) no cracks/chips or fracture. This evaluative system was derived from the California Dental Association quality assessment evaluation system.14 FPDs were examined by two independent clinicians who did not prepare the teeth or cement the prosthesis, and rankings of each criterion were made from 1 to 4 with 4 = excellent, 3 = good, 2 = unacceptable (needs repair or replacement in the near future), and 1 = unacceptable (needs immediate replacement). All clinicians/evaluators were subjected to several calibration exercises that consisted of table top analysis of marginal openings as well as slide evaluations of different clinical situations.
Data were analyzed by logistic regression analysis of the variables with α = 0.05. The consistency of the examiners' scores was evaluated for consistency using a test for the standard deviation of inter-examination.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- missing posterior tooth in a quadrant (first premolars through second molars) that could be restored with a 3-unit FPD
- periodontal pockets of less than 4 mm for each abutment with no periodontal disease
- vital abutment teeth
- crown root ratio of at least 1:1.
Key exclusion criteria (3 listed)
- individuals with medical contraindications to dental treatment
- parafunctional habits
- inability to ensure residence in the area for the next five years
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 |
|---|---|---|
| all-ceramic fixed partial denture | Device | – |
Primary outcome
clinical performance
improved esthetics
improved occlusal function of a lithia disilicate based core ceramic. Performance was measured yearly for 4 years.
1 secondary outcome
wear of opposing enamel
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 22 Sep 2005.
- Results publication: PubMed 15382785Esquivel-Upshaw JF, Anusavice KJ, Young H, Jones J, Gibbs C. Clinical performance of a lithia disilicate-based core ceramic for three-unit posterior FPDs. Int J Prosthodont. 2004 Jul-Aug;17(4):469-75.
- Results publication: PubMed 12473999Gibbs CH, Anusavice KJ, Young HM, Jones JS, Esquivel-Upshaw JF. Maximum clenching force of patients with moderate loss of posterior tooth support: a pilot study. J Prosthet Dent. 2002 Nov;88(5):498-502. doi: 10.1067/mpr.2002.129062.
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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.
Kenneth J Anusavice, PhD, DMD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing all-ceramic fixed partial denture in people with Partial Edentulism, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
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 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: finished, as of the sponsor's last update on 22 Sep 2005. 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 United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
clinical performance. The study lists 3 primary outcomes in all. 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 NCT00223431, which also lists 2 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 22 Sep 2005.