Ceramic Tooth Restorations - a Comparison Study

• Sponsor: University of Oslo (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03517124
• Collaborator: Nordic Institute of Dental Materials (Other)
• Enrollment: 40
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 34.9
• Patients Per Site Per Month: 1.1

Study Details

Study Description

Brief Summary

This randomized clinical study aims to compare success and survival of two different ceramic tooth restoration materials. The hypothesis for the study is that fluoride treated zirconia will retain as good as lithium disilicate reinforced glass ceramic when cemented by the same resin cement.

One group of patients will receive a restoration in fluoride treated zirconia, the other group will receive a restoration in reinforced glass ceramic. All restorations will be cemented in the same manner. At 3, 6, 12 and 24 months the participants will be examined.

Condition or Disease	Intervention/Treatment	Phase
Dental Restoration Failure of Marginal Integrity	Other: Ceramic tooth restoration	N/A

Detailed Description

A randomized controlled clinical study that aims to compare success and survival of potassium hydrogen difluoride (KHF2) etched zirconium dioxide and lithium disilicate reinforced glass ceramic cemented to molars/premolares using dual cure resin cement.

The null hypothesis for the study is that zirconium dioxide and lithium disilicate reinforced glass ceramic will retain equally good tooth substance when cemented with resin cement.

Participants are recruited from the student clinic at Faculty of Dentistry, University of Oslo. Patients who fulfill the inclusion criteria 1) age above 18, 2) require restoration on premolar/molar and 3) are able to come to treatment and recall, are informed about the study and invited to participate. Consent to participation are signed by the patient. At any time and for any reason participants can withdraw from the study.

Personal information will be registered in Service for Sensitive Data, which is a platform to collect, store, analyze and share sensitive data. An encoded research file will be kept separate from the patient journal.The content of this file will be patient journal number and classification of the restoration on a four level scale (Californian Dental Association - CDA) for each recall.

A randomizing tool will be used to decide which ceramic restoration each participant will receive. Treatment will be performed by one clinician. The tooth preparation will be with little retention, and preferably supragingival. For cementing the restorations a standardized protocol for a dual cure resin cement will be used.

Participants only have to pay for the dental technician expenses and will be the same amount regardless of type of ceramic.

Each participant will be examined at 3, 6, 12 and 24 months by a clinician different from the one who performed the treatment. The 4 level CDA classification will be used to characterise each restoration.

Each of the two treatment groups will consist of 20 participants. Significant results will be achieved with the approximate distribution across categories: Category 1: 19,9 %, category 2: 79,4 %, category 3: 4,6 %, category 4: 2,5 %

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Randomized controlled clinical studyRandomized controlled clinical study
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Success and Survival of e.Max and KHF2 Etched Zirconia Cemented With Resin Cement - a Randomized Controlled Clinical Study
• Actual Study Start Date: Jan 5, 2018
• Anticipated Primary Completion Date: Dec 1, 2018
• Anticipated Study Completion Date: Dec 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Zirconia restorations Dental restorations in surface modified zirconia bonded to tooth substance by dual cure resin cement	Other: Ceramic tooth restoration; Dental restorations
Active Comparator: e.max Restorations in e.max bonded to tooth substance by dual cure resin cement	Other: Ceramic tooth restoration; Dental restorations

Outcome Measures

Primary Outcome Measures

1. Survival [2 years]

   Restoration still retained to tooth

2. Loss of retention [2 years]

   Restoration not retained to tooth

Secondary Outcome Measures

1. CDA-index: Romeo [2 years]

   Excellent: Surface smooth and glossy, no mismatch in color or shade

2. CDA-index: Sierra [2 years]

   Acceptable: SRO: Surface slightly rough or pitted, can be polished. SMM: slight mismatch in shade

3. CDA-index: Tango [2 years]

   Correct: TGI: surface glossy irregular, not subject to correction. TMM: mismatch between restoration and adjacent teeth outside normal range.

4. CDA-index: Victor [2 years]

   Replace: VSF: surface fractured. VGP: Gross porosities. VSD: shade in gross disharmony

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

18 years or older In the need of treatment on molars or premolars Lives near by Oslo

-

Exclusion Criteria:

The patients that does not fulfill the inclusion criteria

-

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institute of Clinical Dentistry, University of Oslo	Oslo		Norway	0455

Sponsors and Collaborators

• University of Oslo
• Nordic Institute of Dental Materials

Investigators

• Study Chair: Jan Eirik Ellingsen, Professor, Faculty of Dentistry, Institute of Clinical Dentistry

Study Documents (Full-Text)

None provided.

More Information

Publications

• Ruyter EI, Vajeeston N, Knarvang T, Kvam K. A novel etching technique for surface treatment of zirconia ceramics to improve adhesion of resin-based luting cements. Acta Biomater Odontol Scand. 2017 Apr 14;3(1):36-46. doi: 10.1080/23337931.2017.1309658. eCollection 2017 Jan.

• Responsible Party: Hans Jacob Rønold, Associate Professor, University of Oslo
• ClinicalTrials.gov Identifier: NCT03517124
• Other Study ID Numbers: 2016/957
• First Posted: May 7, 2018
• Last Update Posted: May 7, 2018
• Last Verified: May 1, 2018

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Hans Jacob Rønold, Associate Professor, University of Oslo: Zirconium oxide; surface treatment; resin cement

Study Results

No Results Posted as of May 7, 2018