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

NCT04491097 | Unknown

• 1 other identifier: 10840098-604.01.01-E14107
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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 With the development of new and stronger materials, RBFDs with metal framework have been replaced by glass ceramic, lithium disilicate, fiber-reinforced composite (FRC) and zirconia.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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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. 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

  5 years

Study Arms (2)

Experimental: Panavia V5 resin cement

EXPERIMENTAL

Resin cement with non-MDP monomer

Device: Panavia V5 resin cement

Experimental: Panavia F2.0 resin cement

ACTIVE COMPARATOR

Resin cement with MDP monomer

Device: Panavia F2.0 resin cement

Interventions

Panavia V5 resin cement DEVICE

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.

Experimental: Panavia V5 resin cement

Panavia F2.0 resin cement DEVICE

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.

Experimental: Panavia F2.0 resin cement

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul Medipol University Hospital: lead
• Kuraray Noritake Dental Inc.: collaborator

Study Sites (1)

Istanbul Medipol University School of Dentistry

Istanbul, 34083, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Tooth Loss

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Tooth Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2020
• First Posted: July 29, 2020
• Study Start: June 1, 2017
• Primary Completion: August 1, 2022
• Study Completion: February 1, 2024
• Last Updated: July 29, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)