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Survival Rate of Adhesively Luted Veneers (facings)

Primary Purpose

Tooth Fracture

Status
Unknown status
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Laminate veneer of composite
Laminate veneer of ceramic
Sponsored by
University Medical Center Groningen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tooth Fracture focused on measuring facings, veneers, laminates, existing, restorations, esthetics, dental

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. 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.
  2. An indication for closure of the open space (diastema)
  3. No obvious untreated caries, dental health problems (regularly checked by a dentist).
  4. No untreated periodontal disease (allowed are DPSI 1, 2, 3-)
  5. Good or moderate oral hygiene (plaque score of less than 30% in anterior region before treatment).
  6. 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.
  7. The patient agrees with the research protocol (signing of an agreement form, appendix 4)
  8. 18 Year and older.

Exclusion Criteria:

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

Sites / Locations

  • University Medical Center GroningenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Laminate veneer of composite

Laminate veneer of ceramic

Arm Description

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

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

Outcomes

Primary Outcome Measures

survival rate of laminate veneers
fracture of teeth

Secondary Outcome Measures

Full Information

First Posted
June 12, 2012
Last Updated
August 21, 2018
Sponsor
University Medical Center Groningen
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1. Study Identification

Unique Protocol Identification Number
NCT03145597
Brief Title
Survival Rate of Adhesively Luted Veneers
Acronym
facings
Official Title
Survival Rate of Adhesively Luted Veneers, an In-vivo Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Medical Center Groningen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Patient recruitment: Patients will be recruited from the university clinic. Intake: If the patient is included in the study following the inclusion and exclusion criteria, the patient will be evaluated using the evaluation form. All the data will be collected and impressions will be made. Using the impressions, a wax up will be made on stone models indicating the restorations to be fabricated. With a transparent mould, the situation will be duplicated in the mouth with spot etching and composite. By using this protocol minimal loss of tooth material is guaranteed. Tooth Preparation: After prophylaxis, the teeth will be prepared in a controlled manner using special depth cutting laminate preparation burs (Intensive, Switzerland). The margins will extend to half the way to the inter-proximal contact area. The shape of the cervical margins will be maintained in chamfer form. The incisal edge will be prepared 1.5 mm to create an overlap to the palatinal region for the translucency area in the laminate veneers. Conditioning the tooth surface: Rubberdam will be placed. The preparation surfaces will be etched with 35% phosphoric acid, rinsed thoroughly and dried followed by the application of primer and the bonding agent. Conditioning the existing restorations: The existing composite restaurations will be conditioned using tribochemical silicacoating (CoJet, 30µm SiOx, 3M ESPE) in a Dentoprep (Ronvig, Denmark) intraoral sandblaster. Following this the restauration will be conditioned by silanisation. Conditioning the composite veneers: The inner surfaces of the indirect composite laminates will rinsed with alcohol and thereafter conditioned using tribochemical silicacoating (CoJet, 30µm SiOx, 3M ESPE) using an (Ronvig, Denmark) intra-oral sandblaster. The sandblasting will be approx 13 sec until the inner surface of the restoration change colour visually. Following this the inner surface will be conditioned by silanisation. Conditioning the ceramic veneers: The inner surfaces of the ceramic laminates will be conditioned with hydrofluoric acid 5% and rinsed in neutralizing agent, ultrasonically cleaned and then silanized. After insertion, the excess composite will be removed using handinstruments and finishing burs under continuous water-cooling. Finally the margins will be polished using diamond polishing-paste with a rotating rubber cup. The interproximal surfaces will be finished with Sof-Lex polishing disks and strips. Cementing the restorations: The cementation medium will be a dual-cure aesthetic adhesive cement Variolink veneer. All adhesive restorations will be cemented using ultrasonic insertion techniques. Cementation of the indirect restorations will be performed according to a protocol presented in appendix 2: "Clinical procedures".

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tooth Fracture
Keywords
facings, veneers, laminates, existing, restorations, esthetics, dental

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
split mouth comparison
Masking
Participant
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Laminate veneer of composite
Arm Type
Experimental
Arm Description
Laminate veneer of composite (Estenia, Kuraray Dental), composite laminate veneer, 2-4-6 veneers per patient will be made.
Arm Title
Laminate veneer of ceramic
Arm Type
Experimental
Arm Description
laminate of ceramic (Empress Esthetic, Ivoclar Vivadent), ceramic laminate veneer, 2-4-6 veneers per patient will be made.
Intervention Type
Device
Intervention Name(s)
Laminate veneer of composite
Intervention Description
Composite laminate veneers, 2-4-6 veneers per patient
Intervention Type
Device
Intervention Name(s)
Laminate veneer of ceramic
Intervention Description
laminate of ceramic (Empress Esthetic, Ivoclar Vivadent), ceramic laminate veneer, 2-4-6 veneers per patient will be made.
Primary Outcome Measure Information:
Title
survival rate of laminate veneers
Description
fracture of teeth
Time Frame
up to 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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) 18 Year and older. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
marco Gresnigt, Phd
Phone
0031-50-3632608
Email
marcogresnigt@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Mutlu Ozcan, Prof
Email
mutluozcan@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marco Gresnigt, Phd
Organizational Affiliation
University Medical Center Groningen
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Medical Center Groningen
City
Groningen
ZIP/Postal Code
9713AV
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
marco gresnigt, doctor
Phone
0031647494611
Email
marcogresnigt@yahoo.com
First Name & Middle Initial & Last Name & Degree
marco gresnigt, doctor
First Name & Middle Initial & Last Name & Degree
Marco Cune, professor

12. IPD Sharing Statement

Plan to Share IPD
No
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Survival Rate of Adhesively Luted Veneers

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