Partial Edentulism Clinical Trial
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.
The aims of this research were:
1. 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).
2. 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).
3. 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.
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:
1. General medical history and physical examination
2. Primary casts made with irreversible hydrocolloid impression material
3. Bite force measurement in Newtons made with a gnathodynamometer
4. Pocket depths of abutment teeth
5. 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.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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