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Clinical Evaluation of Ultrathin Occlusal Veneers for the Treatment of Severe Dental Erosion (UOVTDE)

Primary Purpose

Tooth Erosion, Teeth Erosion Due to Vomiting, Teeth Erosion Limited to the Enamel

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Ceramic ultrathin occlusal veneers
Composite resin ultrathin occlusal veneers
Sponsored by
Universidade Federal do Rio de Janeiro
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tooth Erosion focused on measuring tooth erosion, Computer-Aided Design, occlusal veneers, dental veneers

Eligibility Criteria

14 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients presenting advanced erosive lesions ( cumulative score in all sextants greater than or equal 14, according to classification of BARLETT; GANSS; LUSSI, 2008).
  • Absence of pain from the tooth to be restored (excluding expected sensitivity due to dentin exposure due to severe erosion).
  • Application of rubber dam possible
  • High level of oral hygiene.
  • Absence of any active periodontal and pulpal disease.
  • Willingness to wear a nightguard to protect the restorations in case of associated bruxism.

Exclusion Criteria:

  • patients with low level of oral hygiene after all the attempts to improve it failed.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Ceramic restorations

    Composite resin restorations

    Arm Description

    Ceramic ultrathin occlusal veneers

    Composite resin ultrathin occlusal veneers

    Outcomes

    Primary Outcome Measures

    Survival of ultrathin occlusal veneers (ceramic and composite resin) for the restorative treatment of severe dental erosion.

    Secondary Outcome Measures

    Full Information

    First Posted
    April 4, 2017
    Last Updated
    October 24, 2017
    Sponsor
    Universidade Federal do Rio de Janeiro
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03112278
    Brief Title
    Clinical Evaluation of Ultrathin Occlusal Veneers for the Treatment of Severe Dental Erosion
    Acronym
    UOVTDE
    Official Title
    Clinical Evaluation of Ultrathin Occlusal Veneers for the Treatment of Severe Dental Erosion
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    November 2015 (Actual)
    Primary Completion Date
    April 14, 2017 (Actual)
    Study Completion Date
    April 2, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Universidade Federal do Rio de Janeiro

    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
    Ultra-thin bonded posterior occlusal veneers represent a conservative alternative to traditional onlays and complete coverage crowns for the treatment of severe erosive lesions. Therefore, the purpose of this study is to determine whether ceramic and composite resin ultrathin occlusal veneers (0.6 - 1.0 mm thick) are effective in the rehabilitation of patients affected by moderate and severe dental erosion.
    Detailed Description
    Along with data collection, complete arch polyvinyl siloxane impressions are made to obtain accurate diagnostic casts. The occlusal relationship is recorded either at the maximum intercuspal position or centric relation (in cases occlusal space is needed for the restoration of the palatal of upper anterior teeth). An additive waxing is carried out for the eroded teeth. The waxed cast is then duplicated and poured with scannable stone. An average occlusal clearance of 0.4 to 0.6 mm (central groove) to 1.0 to 1.3 mm (cusp tips) is generated by means of rotary diamond burs for the ultrathin occlusal veneers. A rubber dam is placed, and all areas of dentin exposure are ground with a coarse diamond rotary instrument at low speed (1500 rpm) and immediately sealed using a 3-step etch-and-rinse dentin bonding agent. The additive wax replica is scanned first for correlation (Cerec Bluecam; Sirona Dental Systems). The prepared teeth are then scanned in the same way. The teeth are restored using Cerec AC with the Bluecam/MCXL CAD/CAM system (Sirona Dental Systems). By using the design tools of the software set in Biogeneric Copy, the restorations are designed by correlating the preparations with the anatomy of the additive waxing. The ultrathin occlusal veneers are milled either from composite resin blocks (LAVA Ultimate; 3M ESPE) or ceramic blocks (e.max CAD; Ivoclar Vivadent) and polished mechanically with silicon carbide-impregnated brushes. Restorations are then adhesively cemented. After being air-dried, the intaglio surfaces are silanated and heat dried at 68 oC for 5 minutes (Calset; AdDent Inc). The tooth preparations are airborne-particle abraded and etched for 30 seconds with 37.5% phosphoric acid, rinsed, and dried. Adhesive resin (Optibond FL, bottle 2; Kerr Corp) is applied to both fitting surfaces of the restoration. After the luting material (Filtek Z100; 3M ESPE), preheated to 68oC (in Calset; AdDent), is applied to the tooth, the restorations were individually seated, followed by the elimination of excess composite resin and initial light polymerization. Each surface is exposed at 1000 mW/cm2 for 1 minute (20 seconds per surface, repeated 3 times). Margins are then covered with an air barrier and light polymerized for an additional 20 seconds. Margins are finished and polished at the following appointment with diamond ceramic polishers and silicon impregnated rubber polishers. Patients are called for a base line evaluation followed by additional evaluations after 1 year, 2 years and 4 years. Patients Registries: Patients' registries are made in paper forms and immediately digitalized for safety. The form is stored inside an identified folder containing other patient's documents related to the treatment. Upon completion of the registry all data is verified by a third person to check for completeness, calibration and accuracy. Two researchers linked to the project perform patient recruitment (not the evaluators). Patients are interviewed and seen for data collection. If eligibility criteria are meet, the patient receives a comprehensive explanation (accessible language) about the protocol and an invitation to participate. Despite evaluators were previously calibrated; detailed description of the criteria (based on USPHS) is available to the evaluator at every data collection (follow-up appointments). Patients are seen at clinic of the Department of Prosthodontics and Dental Materials of the Dental School of UFRJ. During the follow-up appointments data is collected in sequence by two calibrated evaluators. In case of divergence, a consensus is achieved. Intraoral evaluation is performed with dental explorer and mouth mirror assisted by dental operatory light as well as well as a LED transilluminator for crack chasing. In case of failure (cracks longer than 2 mm, lost fragments or bulk debondings) patients are assigned for repair or change of restoration. The sample of 5 patients for each group was based on the following formula: n = (Zα/2+Zβ)2 * (p1(1-p1)+p2(1-p2)) / (p1-p2)2, with a confidence level of 95%, power of 80% and the survival rates of 90% and 20% for composite and ceramic restorations, respectively (based on previous published data of in vitro fatigue tests).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Tooth Erosion, Teeth Erosion Due to Vomiting, Teeth Erosion Limited to the Enamel, Teeth Erosion Extending Into the Dentine
    Keywords
    tooth erosion, Computer-Aided Design, occlusal veneers, dental veneers

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderOutcomes Assessor
    Masking Description
    Both patient and the evaluators that will asses the performance of the restorations are unaware about the type of material used to fabricate the occlusal veneers
    Allocation
    Randomized
    Enrollment
    10 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Ceramic restorations
    Arm Type
    Active Comparator
    Arm Description
    Ceramic ultrathin occlusal veneers
    Arm Title
    Composite resin restorations
    Arm Type
    Active Comparator
    Arm Description
    Composite resin ultrathin occlusal veneers
    Intervention Type
    Procedure
    Intervention Name(s)
    Ceramic ultrathin occlusal veneers
    Intervention Description
    Severely eroded teeth will be restored with ultrathin occlusal veneers made of ceramic (e.max CAD/Ivoclar Vivadent) by technology CAD-CAM bonded to the teeth (0.6 - 1.2 mm thick).
    Intervention Type
    Procedure
    Intervention Name(s)
    Composite resin ultrathin occlusal veneers
    Intervention Description
    Severely eroded teeth will be restored ultrathin occlusal veneers made of composite resin (Lava Ultimate/3M Espe) by technology CAD-CAM bonded to the teeth (0.6 - 1.2 mm thick).
    Primary Outcome Measure Information:
    Title
    Survival of ultrathin occlusal veneers (ceramic and composite resin) for the restorative treatment of severe dental erosion.
    Time Frame
    1Year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    14 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients presenting advanced erosive lesions ( cumulative score in all sextants greater than or equal 14, according to classification of BARLETT; GANSS; LUSSI, 2008). Absence of pain from the tooth to be restored (excluding expected sensitivity due to dentin exposure due to severe erosion). Application of rubber dam possible High level of oral hygiene. Absence of any active periodontal and pulpal disease. Willingness to wear a nightguard to protect the restorations in case of associated bruxism. Exclusion Criteria: patients with low level of oral hygiene after all the attempts to improve it failed.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Luis H Schlichting, PhD
    Organizational Affiliation
    Federal University of Rio de Janeiro and East Carolina University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
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