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Clinical Outcomes of CAD/CAM Single-Retainer Monolithic Zirconia Ceramic Resin-Bonded Fixed Dentures Bonded With Two Different Resin Cements

Clinical Outcomes of CAD/CAM Single-Retainer Monolithic Zirconia Ceramic Resin-Bonded Fixed Dentures Bonded With Two Different Resin Cements

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04491097
Enrollment
20
Registered
2020-07-29
Start date
2017-06-01
Completion date
2024-02-29
Last updated
2020-07-29

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

Conditions

Denture, Partial, Fixed, Resin-Bonded, Resin Cements, Tooth Loss / Rehabilitation

Brief summary

Congenitally missing tooth is one of the most common anomalies in human dentition. The treatment options of lateral incisor agenesis are closing the space with orthodontic treatment, implant treatment, conventional fixed dental prosthesis (FDPs) and resin-bonded fixed dentures (RBFDs). RBFDs are used frequently for single tooth absence in the anterior region due to their minimal invasive properties, high clinical success and patient satisfaction. With the development of new and stronger materials, RBFDs with metal framework have been replaced by glass ceramic, lithium disilicate, fiber-reinforced composite (FRC) and zirconia. The aim of this study is to evaluate the clinical performance of CAD/CAM single-retainer monolithic zirconia ceramic RBFDs which cemented with two different resin cements.

Detailed description

The aim of this study is to evaluate the clinical performance of CAD/CAM single-retainer monolithic zirconia ceramic RBFDs which cemented with two different resin cements. The project includes 20 patients. Most of the patients have been recruited from the Istanbul Medipol University Dental Clinics in Istanbul. The patients were selected from individuals who have unilateral or bilateral congenitally missing maxillary lateral teeth and wanted to be treated a restoration or undergoing orthodontic treatment. After giving their consent to take part in the study no preparations were made on abutment teeth for RBFDs. Digital impressions were taken with an intraoral digital scanner. The RBFDs were designed using a CAD software, milled and presintered zirconia blocks (KatanaTM Zirconia HT, Kuraray Noritake Dental Inc, Tokyo, Japan). RBFD was adhesively bonded to abutment teeth with one of the two different resin cements (Panavia F2.0 or Panavia V5). The control procedure is: The restoration is evaluated according to presence of mobility or debonding and fracture at the connector area. Gingival harmony and periodontal tissues around the restorations were also examined. Mobility of the abutment tooth was checked in the clinical examination and alveolar bone was examined with periapical x-ray. The controls will take place after two weeks, one year, two years, three years and five years.

Interventions

DEVICEPanavia V5 resin cement

Missing lateral incisor teeth will be restored by zirconia ceramic RBFDs and adhesively bonded with Panavia V5 resin cement.The preperation and restoration of the tooth will be done according to to the guidelines for ordinary prosthetic techniques.

DEVICEPanavia F2.0 resin cement

Missing lateral incisor teeth will be restored by zirconia ceramic RBFDs and adhesively bonded with Panavia F2.0 resin cement.The preperation and restoration of the tooth will be done according to to the guidelines for ordinary prosthetic techniques.

Sponsors

Kuraray Noritake Dental Inc.
CollaboratorUNKNOWN
Istanbul Medipol University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Age
18 Years to 80 Years
Healthy volunteers
Yes

Inclusion criteria

* Participating in the study voluntarily * Horizontal mobility of central incisors ≤1 mm * Central incisors with healthy alveolar bone * 1-1,5 mm overjet * Having a good anterior guidance

Exclusion criteria

* Patients with gingivitis or periodontitis Poor oral hygiene Central incisors with endodontic treatment or periapical disease Central teeth with large fillings or loss of dental structure on the cementation surface Bad oral habits Patients with clinical symptoms of bruxism

Design outcomes

Primary

MeasureTime frameDescription
Survival rate of zirconia ceramic RBFDs5 yearsThe survival was evaluated as described in the studies of Chai et al. (1). They described the survival as the period of time starting at the cementation of the restoration and ending when the restoration was shown to have irreparably failed. The fracture was evaluated according to the study of Heintze and Rousson (2). They made a classification for fracture of zirconia restorations. Three grades of fracture treatment were assigned to this classification: (1) Grade 1: Fracture surfaces were polished. (2) Grade 2: Fracture surfaces were repaired with resin-based composite. (3) Grade 3: Severe chipping fractures required replacement of affected prostheses. 1. Chai J, Chu FC, Newsome PR, et al: Retrospective survival analysis of 3-unit fixed-fixed and 2-unit cantilevered fixed partial dentures. J Oral Rehabil 2005;32:759-765 2. Heintze SD, Rousson V. Survival of zirconia- and metal-supported fixed dental prostheses: a systematic review. Int J Prosthodont 2010;23:493-502

Countries

Turkey (Türkiye)

Outcome results

None listed

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