3-year Clinical Performance of Prefabricated and Composite Veneers

Dental Diseases Clinical Trial

— Edelweiss  

Official title:

3-year Clinical Performance of Prefabricated and Clear Template-formed Resin Composite Veneers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05984472
• Other study ID #: 18-11.1T/15
• Status: Completed
• Phase: N/A
• Start date: January 15, 2019
• Est. completion date: January 15, 2020

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 was to evaluate the clinical performances of Edelweiss prefabricated veneers and direct resin composite restorations (Ceram-X Duo SphereTec) performed with U- veneer transparent templates used for anterior diastema closure and tooth reshaping over 3-year.

The patient group consisted of individuals who applied for aesthetic complaints on their anterior teeth. 21 volunteer individuals without systemic disease were included in the study. Patients were randomly selected for each group. In Group 1; 38 teeth (10 patients) were restored with Edelweiss prefabricated veneers (Edelweiss Dentistry) in combination with Edelweiss nanohybrid resin composite (Edelweiss Dentistry) and Prime&Bond Universal (Dentsply Sirona) adhesive system. In Group 2; 36 teeth (11 patients) were restored with Ceram-X Duo SphereTec (Dentsply Sirona) resin composite in combination with U- veneer (Ultradent) transparent templates and Prime&Bond Universal adhesive systems. Properties of the restorations were evaluated at baseline, 6, 12, 24, and 36 months using Modified Ryge Criteria (USPHS Criteria). Data were evaluated using Chi-Square and Fisher's Exact tests (p=0.05).

Description:

The aim of this study was to evaluate the clinical performances of Edelweiss prefabricated veneers and direct resin composite restorations (Ceram-X Duo SphereTec) performed with U- veneer transparent templates used for anterior diastema closure and tooth reshaping over 3-year.

The study protocol was approved by the Ethical Committee of Ege University, Izmir, Turkey (18-11.1T/15; 28.11.2018). 21 patients (1 male, 20 females, mean age: 35) with aesthetic complaints on their anterior teeth were treated with 74 restorations. 21 volunteer individuals without systemic disease were included in the study. Patients were randomly selected for each group. In Group 1; 38 teeth (10 patients) were restored with Edelweiss prefabricated veneers (Edelweiss Dentistry) in combination with Edelweiss nanohybrid resin composite (Edelweiss Dentistry) and Prime&Bond Universal (Dentsply Sirona) adhesive system. In Group 2; 36 teeth (11 patients) were restored with Ceram-X Duo SphereTec (Dentsply Sirona) resin composite in combination with U- veneer (Ultradent) transparent templates and Prime&Bond Universal adhesive systems.

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. The "Button Try" technique was used for color selection in both groups. Edelweiss sizing guide was used for size selection in Group 1. U-Veneer (Ultradent) transparent templates were tried on the labial surfaces of teeth to select the correct size in Group 2. 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 disposable mouth retractor (OptraGate, Ivoclar Vivadent). 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. Prime&Bond Universal (Dentsply Sirona) adhesive system was applied on the labial surfaces of the teeth in accordance with user instructions in both groups. In Group 1; Edelweiss 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). In Group 2; Ceram-X Duo SphereTec (Dentsply Sirona) nanohybrid resin composite with dentin color was placed on the labial surfaces of the teeth and light-cured (D-Light Pro, GC). After that layer, Ceram-X Duo SphereTec (Dentsply Sirona) enamel shades were placed on the inner surface of the transparent template and pressed against the labial surface of the tooth. After the removal of the excess materials, the resin composite veneer was light-cured for 20 s from each surface. Then the transparent template was removed.

In both groups; 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, 6, 12, 24, and 36 months using Modified Ryge Criteria (USPHS Criteria). Data were evaluated using the Chi-Square and Fisher's Exact tests (p=0.05).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: January 15, 2020
• Est. primary completion date: December 30, 2019
• 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, peg lateral or enamel defect in the anterior teeth

• 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 18 months

• Being over the age of 18

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:
• Edelweiss prefabricated veneers
Individual Randomized Clinical Trial
• Ceram-X Duo SphereTec with U-Veneer
Ceram-X Duo SphereTec with U-Veneer

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 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.	3 years
Primary	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.	3 years
Primary	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.	3 years
Primary	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.	3 years
Primary	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.	3 years