Clinical trial NCT05998980: 6-year Clinical Performance of Prefabricated and Composite Veneers ( Componeer)
Official title: Clinical Comparison of Prefabricated Resin Composite Veneers and Direct Resin Composite Veneers Over 6-years
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Diseases
Tooth Discoloration
Keywords: veneers
prefabricated veneers
anterior restorations
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2023-08-21
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Individual Randomized Assignment
Primary purpose: TREATMENT

Brief summary: The aim of this study is to compare the clinical performance of composite veneers performed in two different ways, indirect and direct methods over a period of 6-year.

30 volunteer patients without systemic diseases and who applied to Ege University School of Dentistry for the esthetic restoration of their anterior diastema (gap) were selected according to inclusion and exclusion criteria. The closure of 102 diastema was randomly performed with prefabricated composite resin veneers (n=15; indirect method- Componeer, Coltène, Altstätten, Switzerland) or direct composite resin veneers (n=15; direct method- Essentia, GC, Japan). These restorations were clinically evaluated at baseline, 1-2-6-year by two experienced and blind examiners according to modified Ryge criteria (USPHS criteria). Color match, marginal discoloration, anatomic form, marginal adaptation, secondary caries, surface roughness, retention, and polishing retention were evaluated for that purpose. Statistical analysis was performed with McNemar and Chi-square tests (p\<0.05).

Detailed description: The aim of this study is to compare the clinical performance of composite veneers performed in two different ways, indirect (Componeer) and direct methods (Essentia) over a period of 6-year.

The study protocol was approved by the Ethical Committee of Ege University, Izmir, Turkey (16-2.1/8; 01.04.2016). 30 patients without any systemic diseases (10 males, 20 females, mean age: 34) and with aesthetic complaints on their anterior teeth were treated with 102 restorations (48 Componeer and 54 Essentia).

In Group 1; 48 teeth (15 patients) were restored with Componeer prefabricated veneers (Coltène, Altstätten, Switzerland) in combination with Synergy D6 nanohybrid resin composite (Coltène) and One Coat Bond (Coltène) adhesive system. In Group 2; 54 teeth (15 patients) were restored with Essentia (GC, Japan) micro-hybrid resin composite in combination with G-Premio Bond (GC) adhesive system.

Periodontal treatments, fillings, and bleaching treatments were performed, if necessary, before any veneer treatment. For the pre-treatment records; 3 photographs (smile, anterior occlusion, and upper anterior teeth alone) were taken from each patient. Both groups used the "Button Try" technique for color selection. Componeer sizing guide was used for size selection in Group 1. Then teeth were cleaned with non-fluoride pumice (Cleanic; Kerr Dental, ABD) using a polishing brush. Isolation of the teeth and retraction of the lips were achieved with a rubber dam (OptraDam, Ivoclar Vivadent, Liechtenstein). Prefabricated veneers were prepared for the cementation process in Group 1. Then the labial surfaces were etched using 36% phosphoric acid for 30 s. The etched surfaces were rinsed for 30 s and dried. One Coat Bond (Coltene) adhesive system was applied on the labial surfaces of the teeth in accordance with user instructions in both groups. In Group 1; Synergy D6 nano hybrid resin composite was placed on the inner surfaces of the prefabricated veneers before being applied on appropriate teeth. Then the restorations were light-cured for 40 s from each surface (D-Light Pro, GC) and polished with a polishing paste (Prisma Gloss Extra Fine, Dentsply, NY, ABD) and a felt wheel.

In Group 2; Essentia (GC) micro-hybrid resin composite with dentin color was placed on the labial surfaces of the teeth and light-cured (D-Light Pro, GC). After that layer, Essentia enamel shades were placed over the labial surface of the tooth and light-cured for 20 s from each surface. The diamond bur contouring was performed and polishing discs (Super-Snap Rainbow Technique Kit, SHOFU) were used. For polishing purposes, a polishing paste (Prisma Gloss Extra Fine, Dentsply, NY, ABD) and a felt Wheel were used.

In group 1; gingival borders were adapted with contouring and polishing discs (Super-Snap Rainbow Technique Kit, SHOFU). Then proximal surfaces were polished using proximal sandpaper strips. Occlusion was checked for premature contacts. Two calibrated observers who were blinded to the objective of this study performed the evaluations. Color match, marginal adaptation, marginal discoloration, anatomic form, retention, secondary caries, and gloss retention were the properties evaluated for the restorations at baseline, 1-2-6-year using Modified Ryge Criteria (USPHS Criteria). Statistical analysis was performed with McNemar and Chi-square tests (p\<0.05).

Eligibility criteria: Inclusion Criteria:

* Being healthy without any chronic disease
* Having diastema in the anterior teeth without any caries
* Not having an occlusal anomaly such as bruxism or anterior crossbite
* Having a good oral hygiene
* Agreeing to come to the recall sessions regularly for 6 years
* Being over the age of 18

Exclusion Criteria:

Exclusion Criteria:

* Having uncontrolled parafunction such as bruxism or anterior deep bite
* Having insufficient oral hygiene
* Being pregnant
* Having a systemic disease

Primary outcomes:
measure: Marginal discoloration
timeFrame: 6 years
measure: Marginal adaptation
timeFrame: 6 years
measure: Retention rate
timeFrame: 6 years
measure: Anatomic form
timeFrame: 6 years
measure: Color match
timeFrame: 6 years
Secondary outcomes:
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Ege University School of Dentistry Department of Restorative
state: Bornova
Study officials:
affiliation: Ege University
name: Sebnem L Turkun, DDS,PhD
role: STUDY_DIRECTOR
References: