6-year Clinical Performance of Prefabricated and Composite Veneers ( Componeer)

Dental Diseases Clinical Trial

Official title:

Clinical Comparison of Prefabricated Resin Composite Veneers and Direct Resin Composite Veneers Over 6-years

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05998980
• Other study ID #: 16-2.1/8
• Status: Completed
• Phase: N/A
• Start date: July 1, 2016
• Est. completion date: January 15, 2017

Study information

• Verified date: August 2023
• Source: Ege University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: January 15, 2017
• Est. primary completion date: December 30, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Dental Diseases
• Stomatognathic Diseases
• Tooth Discoloration

Intervention

Procedure:
• Componeer prefabricated veneers
Individual Randomized Clinical Trial
• Essentia resin composite veneers
Individual Randomized Clinical Trial

Locations

Country	Name	City	State
Turkey	Ege University School of Dentistry Department of Restorative	Izmir	Bornova

Sponsors (1)

Lead Sponsor	Collaborator
Ege University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Marginal discoloration	Marginal discoloration of prefabricated and resin composite veneers Evaluating differently veneer options on anterior teeth with United State Public Health Service criteria regarding marginal discoloration by 2 independent evaluators Marginal discolouration was evaluated by 2 independent clinicians. Visual inspection with a mirror at 18 inches was performed. A score means the higher score of clinical acceptability while C score means that the restoration has failed and needs to be replaced.; Alpha: No discoloration anywhere along the margin between the restoration and the adjacent tooth. Bravo: Slight discoloration along the margin between the restoration and the adjacent tooth.; Charlie: The discoloration penetrated along the margin of the restorative material in a pulpal direction.	6 years
Primary	Marginal adaptation	Marginal adaptation of prefabricated and resin composite veneers Evaluating differently veneer options on anterior teeth with United State Public Health Service criteria regarding marginal adaptation by 2 independent evaluators Marginal discolouration was evaluated by 2 independent clinicians. Visual inspection with a mirror at 18 inches was performed . A score means the higher score of clinical acceptability while C score means that the restoration has failed and needs to be replaced.; Alpha: No discoloration anywhere along the margin between the restoration and the adjacent tooth. Bravo: Slight discoloration along the margin between the restoration and the adjacent tooth.; Charlie: The discoloration penetrated along the margin of the restorative material in a pulpal direction.	6 years
Primary	Retention rate	Retention rates of prefabricated and resin composite veneers Evaluating differently veneer options on anterior teeth with United State Public Health Service criteria regarding retention rates by 2 independent evaluators Marginal discolouration was evaluated by 2 independent clinicians. Visual inspection with a mirror at 18 inches was performed . A score means the higher score of clinical acceptability while C score means that the restoration has failed and needs to be replaced.; Alpha: No discoloration anywhere along the margin between the restoration and the adjacent tooth. Bravo: Slight discoloration along the margin between the restoration and the adjacent tooth.; Charlie: The discoloration penetrated along the margin of the restorative material in a pulpal direction.	6 years
Primary	Anatomic form	Anatomic form of prefabricated and resin composite veneers Evaluating differently veneer options on anterior teeth with United State Public Health Service criteria regarding anatomic form by 2 independent evaluators Marginal discolouration was evaluated by 2 independent clinicians. Visual inspection with a mirror at 18 inches was performed. A score means the higher score of clinical acceptability while C score means that the restoration has failed and needs to be replaced.; Alpha: No discoloration anywhere along the margin between the restoration and the adjacent tooth. Bravo: Slight discoloration along the margin between the restoration and the adjacent tooth.; Charlie: The discoloration penetrated along the margin of the restorative material in a pulpal direction.	6 years
Primary	Color match	Color changes of prefabricated and resin composite veneers Health Service criteria regarding color changes by 2 independent evaluators Marginal discolouration was evaluated by 2 independent clinicians. Visual inspection with a mirror at 18 inches was performed . A score means the higher score of clinical acceptability while C score means that the restoration has failed and needs to be replaced.; Alpha: No discoloration anywhere along the margin between the restoration and the adjacent tooth. Bravo: Slight discoloration along the margin between the restoration and the adjacent tooth.; Charlie: The discoloration penetrated along the margin of the restorative material in a pulpal direction	6 years