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Clinical Evaluation of Monolithic Zirconia Crowns

Clinical Evaluation of Monolithic Zirconia and Metal-ceramic Posterior Crowns

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04943315
Enrollment
70
Registered
2021-06-29
Start date
2019-05-06
Completion date
2023-07-15
Last updated
2023-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Materials

Keywords

crowns, metal-ceramic, monolithic zirconia, clinical evaluation, survival, wear

Brief summary

The objectives of the present study are to compare the survival rates and possible biological and technical complications of metal-ceramic, and monolithic third-generation zirconia posterior crowns. The null hypothesis is that no differences would be found between the parameters studied for each type of restoration.

Detailed description

Seventy patients requiring at least one crown in the posterior region of the maxilla or mandible were included in this study. All subjects were recruited from the Master in Buccofacial Prostheses and Occlusion (Faculty of Odontology, University Complutense of Madrid, Spain). Before treatment, patients were informed of the study objectives, clinical procedures, materials used, advantages and possible risks of the ceramic material, and other therapeutic alternatives. Prior to the study, participants were asked to provide written informed consent. Seventy posterior crowns were produced and allocated in parallel and randomly to either monolithic third-generation zirconia, or metal-ceramic (MC) restorations. The clinical procedures were performed by two experienced clinicians. All participants received oral hygiene instructions and a professional tooth cleaning prior to prosthetic treatment. The abutment teeth were prepared with a 0.8- to 1-mm-wide circumferential chamfer, an axial reduction of 1 mm and an occlusal reduction of 1- to 2.0-mm. A 10- to 15- degree angle of convergence was achieved for the axial walls. Tooth preparations were scanned with an intraoral scanner and the crowns were designed using specific software. The restorations were then cemented using a resin self-adhesive cement. After cementation, occlusal contacts were evaluated, and the adjusted surfaces were polished using a porcelain polishing kit. The 70 crowns were examined at 1week (baseline),1, 2 and 3 years by 2 researchers who were not involved in the restorative treatment.

Interventions

posterior crowns

PROCEDUREMetal-ceramic

posterior crowns

Sponsors

Kuraray Co. Ltd
CollaboratorUNKNOWN
Universidad Complutense de Madrid
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* One posterior tooth (molar or premolar) to be crowned * Vital abutment or abutment with an adequate endodontic treatment * Abutment not crowned previously * Periodontally healthy abutment with no signs of bone resorption or periapical disease. * Adequate occlusogingival height ≥ 4 mm. * Stable occlusion and the presence of natural antagonist tooth.

Exclusion criteria

* Patients who present reduced crown length (less than 4 mm occlusogingival height). * Poor oral hygiene, high caries activity, or active periodontal disease

Design outcomes

Primary

MeasureTime frameDescription
Quality of restorations at baselineBaselineThe quality of the surface and color, anatomical form and marginal integrity was assessed using the California Dental Association's (CDA) assessment system. Each CDA criterion was ranked on a scale of 1 to 4, where 4 = excellent, 3 = good, 2 = unacceptable (repair), and 1 = unacceptable (replacement).
Quality of restorations at 1 year1 yearThe quality of the surface and color, anatomical form and marginal integrity was assessed using the California Dental Association's (CDA) assessment system. Each CDA criterion was ranked on a scale of 1 to 4, where 4 = excellent, 3 = good, 2 = unacceptable (repair), and 1 = unacceptable (replacement).
Quality of restorations at 2 years2 yearsThe quality of the surface and color, anatomical form and marginal integrity was assessed using the California Dental Association's (CDA) assessment system. Each CDA criterion was ranked on a scale of 1 to 4, where 4 = excellent, 3 = good, 2 = unacceptable (repair), and 1 = unacceptable (replacement).
Quality of restorations at 3 years3 yearsThe quality of the surface and color, anatomical form and marginal integrity was assessed using the California Dental Association's (CDA) assessment system. Each CDA criterion was ranked on a scale of 1 to 4, where 4 = excellent, 3 = good, 2 = unacceptable (repair), and 1 = unacceptable (replacement).
Plaque Index (PI) at baselinebaselinePlaque Index (PI) of the abutment and control teeth. A score of 0 to 3 was assigned. Higher score means a worse outcome.
Plaque Index (PI) at 1 year1 yearPlaque Index (PI) of the abutment and control teeth. A score of 0 to 3 was assigned. Higher score means a worse outcome.
Plaque Index (PI) at 2 years2 yearsPlaque Index (PI) of the abutment and control teeth. A score of 0 to 3 was assigned. Higher score means a worse outcome.
Plaque Index (PI) at 3 years3 yearsPlaque Index (PI) of the abutment and control teeth. A score of 0 to 3 was assigned. Higher score means a worse outcome.
Gingival Index (GI) at baselineBaselineGingival Index (GI) of the abutment and control teeth. A score of 0 to 3 was assigned. Higher score means a worse outcome.
Gingival Index (GI) at 1 year1 yearGingival Index (GI) of the abutment and control teeth. A score of 0 to 3 was assigned. Higher score means a worse outcome.
Gingival Index (GI) at 2 years2 yearsGingival Index (GI) of the abutment and control teeth. A score of 0 to 3 was assigned. Higher score means a worse outcome.
Gingival Index (GI) at 3 years3 yearsGingival Index (GI) of the abutment and control teeth. A score of 0 to 3 was assigned. Higher score means a worse outcome.
Margin stability at baselineBaselineTo assess the gingival margin stability throughout the evaluation period (subgingival, isogingival or supragingival)
Margin stability at 1 year1 yearTo assess the gingival margin stability throughout the evaluation period (subgingival, isogingival or supragingival)
Margin stability at 2 years2 yearsTo assess the gingival margin stability throughout the evaluation period (subgingival, isogingival or supragingival)
Margin stability at 3 years3 yearsTo assess the gingival margin stability throughout the evaluation period (subgingival, isogingival or supragingival)
Probing depth at baselineBaselineProbing depth of the abutment and control teeth. A score of 0 to 4 was assigned. Higher score means a worse outcome
Probing depth at 1 year1 yearProbing depth of the abutment and control teeth. A score of 0 to 4 was assigned. Higher score means a worse outcome
Probing depth at 2 years2 yearsProbing depth of the abutment and control teeth. A score of 0 to 4 was assigned. Higher score means a worse outcome
Probing depth at 3 years3 yearsProbing depth of the abutment and control teeth. A score of 0 to 4 was assigned. Higher score means a worse outcome
Patient satisfaction at 3 years3 yearsSubjective patient satisfaction using Visual analogue scale (VAS) ranged from 0 (worst possible result) to10 (best possible result). The items analyzed were: esthetics, function, comfort, overall satisfaction

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026