Survival of Hybrid Laminate Veneers Using Two Different Tooth Preparation Techniques:Randomized Clinical Trial

Sponsor

Cairo University (Other)

Overall Status

Completed

CT.gov ID

NCT04515069

Collaborator

(none)

Enrollment

Location

Arms

24.7

Actual Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of this study was to evaluate the survival of laminate veneers constructed using a recent polymer-infiltrated ceramic network material following the aesthetic pre-evaluative temporary (APT) technique of tooth preparation in comparison to traditional technique.

Condition or Disease	Intervention/Treatment	Phase
Discoloration, Tooth Malformed Tooth Diastema	Procedure: traditional technique of tooth preparation Procedure: aesthetic preevaluative temporary technique for tooth preparation	N/A

Detailed Description

Six recruited patients (4 females, 2 males; ranging from: 20-30 years old and with mean age 24.6 years), who needed indirect laminate veneer restorations were included in this study. Patients were selected from the outpatient clinic of the Department of Fixed Prosthodontics,Faculty of Dentistry, Cairo University The participants received a total of 54 laminate veneers between April 2017 and February 2018. Written informed consent was acquired from all participating patients. Randomization was done using a computer generated 2 column list by the aid of Random.org in a 1:1 ratio. Allocation concealment was achieved using numbered cards in opaque sealed envelopes. Aluminium foil was placed inside the envelope to render the envelope impermeable to intense light. These envelopes were placed in a box and each participant was allowed to grasp one envelop the day of operation. Allocation concealment was performed by an investigator with no clinical involvement in the trial. This study is a single blinded study as the assessor was blinded to the assigned study groups. Blinding of the participants was not applicable as one of the techniques required extra visits. Blinding of the operator was not applicable as one clinician performed the tooth preparation in both techniques.A total of 54 laminate veneers were divided into two equal groups (n=27) according to the technique of tooth preparation: group T: traditional technique and group A: aesthetic pre-evaluative temporary technique. VITA ENAMIC material was used for CAD/CAM construction of laminate veneers. Cementation was performed using a light cured resin cement. The laminate veneers were evaluated at baseline, after 3, 6 and 12 months according to the modified United States Public Health Service (USPHS) criteriea. The data was collected, tabulated and statistically analyzed.

Study Design

Study Type:

Interventional

Actual Enrollment :

6 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Masking Description:

Randomization was done using a computer generated 2 column list by the aid of Random.org in a 1:1 ratio. Allocation concealment was achieved using numbered cards in opaque sealed envelopes. Aluminium foil was placed inside the envelope to render the envelope impermeable to intense light. These envelopes were placed in a box and each participant was allowed to grasp one envelop the day of operation. Allocation concealment was performed by an investigator with no clinical involvement in the trial. This study is a single blinded study as the assessor was blinded to the assigned study groups. Blinding of the participants was not applicable as one of the techniques required extra visits. Blinding of the operator was not applicable as one clinician performed the tooth preparation in both techniques.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 13, 2017

Actual Primary Completion Date :

Mar 20, 2019

Actual Study Completion Date :

May 5, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Traditional technique for tooth preparation. Tooth preparation performed directly on the tooth structure	Procedure: traditional technique of tooth preparation 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: Group T
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.	Procedure: aesthetic preevaluative temporary technique for tooth preparation 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: Group A

Arm

Intervention/Treatment

Active Comparator: Traditional technique for tooth preparation.

Tooth preparation performed directly on the tooth structure

Procedure: traditional technique of tooth preparation

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:

Group T

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.

Procedure: aesthetic preevaluative temporary technique for tooth preparation

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:

Group A

Outcome Measures

Primary Outcome Measures

Survival of laminate veneers using modified USPHS [1 year]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 44 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.