- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04515069
Survival of Hybrid Laminate Veneers Using Two Different Tooth Preparation Techniques:Randomized Clinical Trial
Survival of a Recent Polymer- Infiltrated Ceramic Network Laminate Veneer Material Using Aesthetic Preevaluative Temporary (APT) Technique Versus Traditional Technique in the Aesthetic Zone:Randomized Clinical Trial
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Cairo, Egypt, 11728
- Yara Attia
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Patient-related criteria:
- Patients consulting the outpatient clinic of the department of Fixed Prosthodontics, Faculty of Dentistry, Cairo University.
- Able to tolerate necessary restorative procedures.
- Provide written consent.
- Accepts the one year follow-up period.
Tooth related criteria:
- Malaligned and malformed teeth in the aesthetics zone
- Multiple spacing
- Diastema
- Slightly and moderately discolored teeth
- Good oral hygiene
Exclusion Criteria:
Patient-related criteria:
- Medically compromised patients, as they would not be able to attend multiple appointments or might require special management.
- Uncooperative patients, who would not abide by the instructions or attend the appointments.
Tooth related criteria:
- Deciduous teeth; as the study was targeting only permanent teeth.
- Teeth with previous restorations, which might add another variable to the study (type of old restorative material, extent of recurrent caries). This could also affect the bond of laminate veneers to tooth structure.
- Patients with parafunctional habits, large restorations, or excessive tooth wear.
- Initially, scaling and polishing was performed. Patients were instructed on improving their oral hygiene and maintaining effective plaque control. However, if their gingival health did not improve, they were excluded from the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Traditional technique for tooth preparation.
Tooth preparation performed directly on the tooth structure
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Depth cutter wheels of predetermined depths (Komet, Germany) were used to perform the preparation directly on the tooth structure. Depth cuts were performed on the labial surface using depth cutter wheels (Komet, Germany) with radius of 0.3 mm and 0.5 mm which is directly related to the thickness of the laminate veneers in the cervical and incisal one thirds respectively. Then islands of tooth structure between depth orientation grooves were removed. Proximal reduction: The interproximal reduction was completed just labial to the contact areas using a round end tapered diamond stone (Mani, Japan), and polishing was performed using polishing strips (Sof-Lex, 3M ESPE, Seefeld, Germany). Incisal reduction: Vertical depth grooves were created. Then, the round end tapered diamond stone (Mani, Japan)was used to create 1.5 mm incisal butt joint preparation. Then, finishing and polishing of tooth preparation was performed.
Other Names:
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ACTIVE_COMPARATOR: Aesthetic preevaluative temporary technique
Aesthetic pre-evaluative temporary (APT) was fabricated according the planned wax-up.
Once the APT was approved both aesthetically and functionally, tooth preparation was performed through the APT.
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The data obtained from digital smile design was used for construction of the diagnostic wax-up. The wax-up was then be transferred to the mouth using a silicone index, creating the aesthetic pre-evaluative temporary (APT). The APT was tested esthetically and functionally. Once approved by the operator and the patient, tooth preparation was performed through the APT. Depth cuts were performed similar to those performed in the traditional preparation with the difference of being prepared on the aesthetic pre-evaluative temporary instead of directly on the dental structure. Using tapered stone with round end (Mani, Japan), islands of tooth structure between depth orientation grooves were removed. Proximal reduction, Incisal reduction Finishing and polishing of tooth preparation were carried out using the same technique as in the Group T with the difference of being performed through the APT, resulting in minimal tooth preparation
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Survival of laminate veneers using modified USPHS
Time Frame: 1 year
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Patients were called back after 1 week as the baseline to assess the veneer restorations.
Assessment was carried out by an experienced observer blinded to the assigned study group for each patient.
Laminate veneers were examined at baseline, after 3, 6 and 12 months according to the modified United States Public Health Service (USPHS) criteriae and the USPHS scores of Alfa, Bravo and Charlie were used for rating .
Patients were also questioned about possible post-operative complaints.
Digital photographs were made after placement of the veneers and during follow-up sessions.
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1 year
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Hanaa Zaghloul, PhD, Professor of Fixed Prosthodontics, Misr International University
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 151021
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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