Clinical Evaluation of Four Aesthetic Restorations in Non-carious Cervical Lesions

Noncarious Cervical Lesions Clinical Trial

Official title:

Clinical Evaluation of Four Aesthetic Restorations in Non-carious Cervical Lesions: a Randomised Controlled Split-mouth Clinical Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04261140
• Other study ID #: 2019/19
• Status: Withdrawn
• Phase: N/A
• Start date: July 2019
• Est. completion date: May 2021

Study information

• Verified date: May 2020
• Source: Recep Tayyip Erdogan University Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To compare the clinical performance of high-viscosity glass ionomer, flowable composite, bulkfill composite and nanohybrid composite restorations in non-carious cervical lesions (NCCLs).

Description:

One hundred fourty NCCLs were randomised into four groups according to a split-mouth design. Clinical evaluations will be performed after 1 week, 3 months, 6 months, using FDI (World Dental Federation) criteria.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2021
• Est. primary completion date: July 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

Inclusion Criteria:

• had at least four non-carious symmetrical cervical lesions,

• had permanent dentition and were older than 20 years old,

• had cervical margins in dentin

Exclusion Criteria:

• periodontal disease

• pregnant or breastfeeding

• being under orthodontic therapy

Related Conditions & MeSH terms

• Noncarious Cervical Lesions
• Uterine Cervical Diseases

Intervention

Other:
• EQUIA Forte Fil
Apply cavity conditioner (20% polyacrylic acid) 10 s on enamel and dentine, rinse Mix 10 s and apply bulk-fill Apply EQUIA coat and light cure for 20 s unit
• Clearfil Majesty Esthetic
Apply in 2-mm increment, light cure for 20 s
• NexComp Flow
Apply in 2-mm increment light cure for 20 s
• 3M Espe Bulk-fill
Apply in single increment up to 4 mm; light curing for 20 s

Locations

Country	Name	City	State
Turkey	Recep Tayyip Erdogan University Dentistry Faculty	Rize

Sponsors (1)

Lead Sponsor	Collaborator
Recep Tayyip Erdogan University Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	evaluation of restoration on cervical lesions	According to FDI criteria (aesthetic, biological and fuctional) score 1, clinically very good; score 2, clinically good; score 3, clinically sufficient; score 4, clinically unsatisfactory; score 5, clinically poor. Scores 1-3 show clinically acceptable restoration, while scores 4 and 5 indicate failure	6 months