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

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 With the development of new and stronger materials, RBFDs with metal framework have been replaced by glass ceramic, lithium disilicate, fiber-reinforced composite (FRC) and zirconia.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.

Study Overview

• Status: Active, not recruiting
• Conditions: Denture, Partial, Fixed, Resin-Bonded; Tooth Loss / Rehabilitation; Resin Cements
• Intervention / Treatment: Device: Panavia V5 resin cement; Device: Panavia F2.0 resin cement

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.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34083
    • Istanbul Medipol University School of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental: Panavia V5 resin cement; Resin cement with non-MDP monomer	Device: Panavia 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.
Active Comparator: Experimental: Panavia F2.0 resin cement; Resin cement with MDP monomer	Device: Panavia 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival rate of zirconia ceramic RBFDs	The 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.; 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; Heintze SD, Rousson V. Survival of zirconia- and metal-supported fixed dental prostheses: a systematic review. Int J Prosthodont 2010;23:493-502	5 years

Collaborators and Investigators

• Sponsor: Istanbul Medipol University Hospital
• Collaborators: Kuraray Noritake Dental Inc.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2017
• Primary Completion (Anticipated): August 1, 2022
• Study Completion (Anticipated): February 1, 2024

Study Registration Dates

• First Submitted: July 14, 2020
• First Submitted That Met QC Criteria: July 28, 2020
• First Posted (Actual): July 29, 2020

Study Record Updates

• Last Update Posted (Actual): July 29, 2020
• Last Update Submitted That Met QC Criteria: July 28, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Tooth Diseases; Tooth Loss
• Other Study ID Numbers: 10840098-604.01.01-E14107

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No