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

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

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

Study Overview

• Status: Withdrawn
• Conditions: Noncarious Cervical Lesions
• Intervention / Treatment: Other: EQUIA Forte Fil; Other: NexComp Flow; Other: 3M Espe Bulk-fill; Other: Clearfil Majesty Esthetic

Detailed 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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Rize, Turkey, 53000
    • Recep Tayyip Erdogan University Dentistry Faculty

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: High-viscosity glass ionomer	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
EXPERIMENTAL: flowable composite	Other: NexComp Flow; Apply in 2-mm increment light cure for 20 s
EXPERIMENTAL: bulkfill composite	Other: 3M Espe Bulk-fill; Apply in single increment up to 4 mm; light curing for 20 s
EXPERIMENTAL: nanohybrid composite	Other: Clearfil Majesty Esthetic; Apply in 2-mm increment, light cure for 20 s

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Recep Tayyip Erdogan University Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): July 1, 2019
• Primary Completion (ANTICIPATED): July 1, 2020
• Study Completion (ANTICIPATED): May 1, 2021

Study Registration Dates

• First Submitted: February 4, 2020
• First Submitted That Met QC Criteria: February 6, 2020
• First Posted (ACTUAL): February 7, 2020

Study Record Updates

• Last Update Posted (ACTUAL): May 6, 2020
• Last Update Submitted That Met QC Criteria: May 4, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: cervical lesion; bulkfill composite; High-viscosity glass ionomer; flowable composite; nanohybrid composite
• Additional Relevant MeSH Terms: Uterine Diseases; Uterine Cervical Diseases
• Other Study ID Numbers: 2019/19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will be available within 1 years of study completion

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No