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Clinical Performance of Two Different Bevel Preparations in Class IV Lesions Using Nanofilled Composite

Clinical Performance of Two Different Bevel Preparations in Class IV Lesions Using Nanofilled Composite: A Randomized Clinical Study

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06220890
Enrollment
100
Registered
2024-01-24
Start date
2022-06-22
Completion date
2024-03-31
Last updated
2024-01-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Class IV Dental Caries

Brief summary

The purpose of the study is to compare and evaluate clinical performance between two different bevel preparations in Class IV lesions using nano-filled composite restorations.

Detailed description

The main reason for failure in anterior composite restorations is restoration fracture and aesthetic appearance. Restorations in anterior teeth are subjected to high-impact stresses produced through an incisal angle in class IV restorations, require high fracture resistance. It is the biomechanics of restorations that determine their functionality, retention, and functional longevity. Stair-step chamfer preparation is a modification of chamfer preparation that follows the vertical and horizontal anatomical contours, hence, achieves high degree of aesthetics along with exposure of enamel for bonding. According to current literature, no studies have analyzed the clinical performance of different bevel design using direct nano-filled composite resin restorations in Class IV lesions. Therefore, the aim of this study is to compare and evaluate clinical performance between two different bevel preparations in Class IV lesions using nano-filled composite restorations. Study will be conducted at Post Graduate Institute of Dental Sciences, Rohtak in Department of Conservative Dentistry & Endodontics. Time Frame of the study will be 12 months. Patients ≥ 18 years of age with Class IV lesion in maxillary central incisor, lateral incisor due to fracture or primary/ recurrent caries will be enrolled in the study. After complete carious removal, tooth will be prepared in class IV lesions according to 2mm bevel or 2mm stair-step chamfer preparation group, selective enamel etching and bonding of the tooth using universal adhesive will be done. The cavity will be restored using nanofilled composite by layering technique. The restorations will be undergoing the standard finishing and polishing procedures. Follow up of patients will be carried out at 3 months for clinical evaluation, 6 and 12 months for both radiographic and clinical evaluation. Restorations will be assessed clinically according to FDI criteria.

Interventions

PROCEDURETooth preparation in Class IV lesions with 2mm bevel

Class IV cavity with 2 mm bevel will be restored with nano-filled composite and clinical performance will be evaluated based on FDI criteria.

PROCEDURETooth preparation in Class IV lesions with 2mm stair-step chamfer

Class IV cavity with 2 mm stair step chamfer will be restored with nano-filled composite and clinical performance will be evaluated based on FDI criteria.

Sponsors

Postgraduate Institute of Dental Sciences Rohtak
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Patients ≥ 18 years of age at the time of treatment. * Class IV lesion in maxillary central incisor, lateral incisor due to fracture or primary/ recurrent caries. * Patients with complete and normal occlusion and teeth with proximal contacts. * Patients not having periodontal or pulpal diseases. * Positive response to the cold test and electric pulp test.

Exclusion criteria

* Patients with immunocompromised status or debilitating systemic diseases. * Patients with uncontrolled parafunctional habits. * Class IV lesion with involvement of pulp.ix * Class IV lesions with no involvement of dentin. * Patients presenting extremely poor oral hygiene. * Patient with high caries index

Design outcomes

Primary

MeasureTime frameDescription
Clinical performance of 2 mm bevel and stair step chamfer in Class IV lesions using nanofilled composite restorations.12 monthsEvaluation of Clinical and radiographic success of class IV lesions with 2mm bevel and stair step chamfer with nanofilled composite restorations will be assessed by FDI criteria.

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026