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

NCT ID: NCT06220890

Last Updated: 2024-01-24

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-22
• Study Completion Date: 2024-03-31

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.

Conditions

Class IV Dental Caries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Class IV lesion with 2 mm bevel (BV)

All the enamel margins will be beveled at a 45-degree angle of the width of approximately 2 mm, enamel selectively etched, bonding of tooth using universal adhesive will be done and restored with nano-filled composite.

Group Type: EXPERIMENTAL

Tooth preparation in Class IV lesions with 2mm bevel

Intervention Type: PROCEDURE

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

Class IV lesion with 2mm stair-step chamfer (SSC)

Enamel margins facially will be prepared 2mm deep in stair-step chamfer form, enamel selectively etched, and bonding of tooth using universal adhesive will be done and restored with nano-filled composite.

Group Type: EXPERIMENTAL

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

Intervention Type: PROCEDURE

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.

Interventions

Tooth 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.

Intervention Type: PROCEDURE

Tooth 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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Postgraduate Institute of Dental Sciences Rohtak

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dr Sanjay Tewari, MDS

Role: STUDY_DIRECTOR

POSTGRADUATE INSTITUTE OF DENTAL SCIENCE,ROHTAK ,HARYANA,INDIA,124001

Locations

PGIDS

Rohtak, Haryana, India

Countries

India

Other Identifiers

Akankshya Behera

Identifier Type: -

Identifier Source: org_study_id