NCT Number: NCT05707780
The objectives of the present prospective randomized clinical study are to evaluate and to compare the survival and success rates, possible biological and technical complications, and the clinical performance of metal-ceramic, monolithic zirconia and resin-matrix posterior crowns.
The null hypothesis is that no differences would be found between the parameters studied for each type of restoration.
Interested in participating?
Request Info20 year–80 year
All sexes
Interventional
Not applicable
Madrid, 28040, Spain
Location status: Recruiting
BENJAMIN SERRANO, PhD
SUB_INVESTIGATOR
CARLOS LOPEZ-SUAREZ, PhD
SUB_INVESTIGATOR
CELIA TOBAR, PhD
SUB_INVESTIGATOR
ESTHER GONZALO, PhD
SUB_INVESTIGATOR
JESUS PELAEZ, PhD
CONTACT
JORGE ARELLANO, Bachelor
SUB_INVESTIGATOR
MARIA JESUS SUAREZ, PhD
CONTACT
VERONICA RODRIGUEZ, PhD
SUB_INVESTIGATOR
A total of 60 patients, in whom the placement of a crown in the posterior region of the maxilla or mandible was indicated, will be included in the study. The patients will be recruited from the Master of Buccofacial Prostheses and Occlusion (School of Dentistry; University Complutense of Madrid). Prior to treatment, patients will be informed regarding the aims of the study, the clinical procedure, the materials used, the risks and benefits of ceramic restorations and the alternatives to the proposed treatment. All the patients will be provided with a written informed consent for the inclusion in this study, Ninety posterior crowns will be produced and assigned in parallel and randomly to either resin-matrix ceramic, zirconia or metal-ceramic restorations. Three experienced prosthodontists will treat the patients. Abutment preparation will be performed in a standardized manner: circumferentially chamfer (1 mm in width), axial reduction of 1 mm, and an occlusal reduction of 1.5 to 2 mm. The tapering angle between the axial walls will be approximately 10- to 12- degrees. Full-arch digital impressions will be taken using an Intraoral Scanner. The restorations will be cemented with a resin cement. The restorations will be examined at one week (baseline), 1, 2, and 3 years, by two researchers who were not involved in the restorative treatment
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
posterior crowns
Other names: VarseoSmile crown
posterior crowns
posterior crowns
Time frame: 3 years
Survival and success rates with Kaplan Meier method
Time frame: Baseline
The restorations will be assessed using the California Dental Association's assessment system, for the surface and color, anatomic form, and margin integrity.
Time frame: 1 year
The restorations will be assessed using the California Dental Association's assessment system, for the surface and color, anatomic form, and margin integrity.
Time frame: 2 years
The restorations will be assessed using the California Dental Association's assessment system, for the surface and color, anatomic form, and margin integrity.
Time frame: 3 years
The restorations will be assessed using the California Dental Association's assessment system, for the surface and color, anatomic form, and margin integrity.
Time frame: Baseline
Plaque Index (PI) of the abutment and control tooth will be assessed. A score of 0 to 3 will be assigned. Higher score will mean a worse outcome
Time frame: 1 year
Plaque Index (PI) of the abutment and control tooth will be assessed. A score of 0 to 3 will be assigned. Higher score will mean a worse outcome
Time frame: 2 years
Plaque Index (PI) of the abutment and control tooth will be assessed. A score of 0 to 3 will be assigned. Higher score will mean a worse outcome
Time frame: 3 years
Plaque Index (PI) of the abutment and control tooth will be assessed. A score of 0 to 3 will be assigned. Higher score will mean a worse outcome
Time frame: Baseline
Gingival Index (GI) of the abutment and control tooth will be assessed. A score of 0 to 3 will be assigned. Higher score will mean a worse outcome
Time frame: 1 year
Gingival Index (GI) of the abutment and control tooth will be assessed. A score of 0 to 3 will be assigned. Higher score will mean a worse outcome
Time frame: 2 years
Gingival Index (GI) of the abutment and control tooth will be assessed. A score of 0 to 3 will be assigned. Higher score will mean a worse outcome
Time frame: 3 years
Gingival Index (GI) of the abutment and control tooth will be assessed. A score of 0 to 3 will be assigned. Higher score will mean a worse outcome
Time frame: Baseline
Probing depth of the abutment and control tooth. A score of 0 to 4 will be assigned. Higher score will mean a worse outcome
Time frame: 1 year
Probing depth of the abutment and control tooth. A score of 0 to 4 will be assigned. Higher score will mean a worse outcome
Time frame: 2 years
Probing depth of the abutment and control tooth. A score of 0 to 4 will be assigned. Higher score will mean a worse outcome
Time frame: 3 years
Probing depth of the abutment and control tooth. A score of 0 to 4 will be assigned. Higher score will mean a worse outcome
Time frame: Baseline
To assess the gingival margin stability of the abutment and control tooth throughout the evaluation period (subgingival, isogingival or supragingival)
Time frame: 1 year
To assess the gingival margin stability of the abutment and control tooth throughout the evaluation period (subgingival, isogingival or supragingival)
Time frame: 2 years
To assess the gingival margin stability of the abutment and control tooth throughout the evaluation period (subgingival, isogingival or supragingival)
Time frame: 3 years
To assess the gingival margin stability of the abutment and control tooth throughout the evaluation period (subgingival, isogingival or supragingival)
Time frame: 3 years
Subjective patient satisfaction using Visual analogue scale (VAS) ranged from 0 (worst possile result) to 10 (best possible result)
Contact information is provided by the study sponsor or research team.
JESUS PELAEZ, PhD
CONTACT
MARIA JESUS SUAREZ, PhD
CONTACT
Universidad Complutense de Madrid
Other
Clinical Evaluation of Resin Matrix Ceramic and Zirconia Posterior Crowns
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04533113
Dental Caries, Dental Materials
Sant Cugat del Vallès, Barcelona, Spain
View Trial DetailsNCT07421687
Dental Materials, Dental Plaque Accumulation
Merkez, Edirne, Turkey (Türkiye)
View Trial DetailsNCT06254053
Dental Caries in Children, Dental Materials
View Trial DetailsNCT04446078
Dental Implants, Dental Materials
Lisbon, Portugal
View Trial Details