Survival Rate of Adhesively Luted Veneers

NCT03145597 | Unknown DMC

• 1 other identifier: Laminate veneers
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

The aims of this clinical study are: To evaluate the clinical performance between indirect composite and ceramic laminate veneers: Main interests are:

• colour stability of the restoration (digital measurement in follow up)
• failure mode of the restoration
• wear of the restoration and antagonist Hypothesis:
• The colour stability of indirect composite restorations will not be different from the ceramic restorations.
• The indirect composite restorations will not be more prone to failure than the ceramic restorations.
• Antagonist wear and restorative material wear will be similar for both ceramic and composite. Material and Methods The laminates will be fabricated according to a specified protocol. In order to avoid possible noticeable differences in case of distinct levels of possible discoloration, a modified split mouth design is employed where the central incisors and the symmetric other teeth receive the same type of restoration. Randomization is based on the paired teeth and it is performed using the flip of a coin for the choice of material. Evaluation will be performed at baseline and at follow-up visits annually up to 2 years.

Conditions

Tooth Fracture

Keywords

facings; veneers; laminates; existing; restorations; esthetics; dental

Outcome Measures

Primary Outcomes (1)

• survival rate of laminate veneers

  fracture of teeth

  up to 24 months

Study Arms (2)

Laminate veneer of composite

EXPERIMENTAL

Laminate veneer of composite (Estenia, Kuraray Dental), composite laminate veneer, 2-4-6 veneers per patient will be made.

Device: Laminate veneer of composite

Laminate veneer of ceramic

EXPERIMENTAL

laminate of ceramic (Empress Esthetic, Ivoclar Vivadent), ceramic laminate veneer, 2-4-6 veneers per patient will be made.

Device: Laminate veneer of ceramic

Interventions

Laminate veneer of composite DEVICE

Composite laminate veneers, 2-4-6 veneers per patient

Laminate veneer of composite

Laminate veneer of ceramic DEVICE

laminate of ceramic (Empress Esthetic, Ivoclar Vivadent), ceramic laminate veneer, 2-4-6 veneers per patient will be made.

Laminate veneer of ceramic

Eligibility Criteria

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

You may qualify if:

• The veneers will be placed on central incisors, lateral incisors, canines in the maxilla. Indications will involve replacing worn, discoloured composite restorations and existing veneers, or correcting discoloured, malformed and/or misaligned teeth.
• An indication for closure of the open space (diastema)
• No obvious untreated caries, dental health problems (regularly checked by a dentist).
• No untreated periodontal disease (allowed are DPSI 1, 2, 3-)
• Good or moderate oral hygiene (plaque score of less than 30% in anterior region before treatment).
• Endodontic treatment with good outcome (root canal densely filled with gutta-percha 0.5-1.5 mm from apex) with only a restoration on palatinal side.
• The patient agrees with the research protocol (signing of an agreement form, appendix 4)
• Year and older.

You may not qualify if:

• Patients with only one tooth to restore, or two central incisors.
• Considerable horizontal and/or vertical mobility of abutment teeth: tooth mobility index score 2 or 3.
• Considerable periodontal disease without treatment (DPSI 3+ and 4)
• Endodontic treatment with extensive loss of tooth tissue (more than 2/3 of crown is restored with restoration material).
• Restoration of whole crown, more than 2/3 of coronal part of the teeth is restored.
• Patients that still want to bleach their teeth or bleached teeth less than 3 weeks before the treatment.

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (1)

University Medical Center Groningen

Groningen, 9713AV, Netherlands

RECRUITING

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MeSH Terms

Conditions

Tooth Fractures

Condition Hierarchy (Ancestors)

Tooth Injuries; Tooth Diseases; Stomatognathic Diseases; Wounds and Injuries

Study Officials

• Marco Gresnigt, Phd

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

marco Gresnigt, Phd

CONTACT

0031-50-3632608; marcogresnigt@yahoo.com

Mutlu Ozcan, Prof

CONTACT

mutluozcan@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: dr.

Model Details: split mouth comparison

Study Record Dates

• First Submitted: June 12, 2012
• First Posted: May 9, 2017
• Study Start: June 1, 2017
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: August 22, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)