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

January 13, 2024 updated by: Postgraduate Institute of Dental Sciences Rohtak

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Haryana
      • Rohtak, Haryana, India, 124001
        • PGIDS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Procedure: 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.
Experimental: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical performance of 2 mm bevel and stair step chamfer in Class IV lesions using nanofilled composite restorations.
Time Frame: 12 months
Evaluation 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.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Postgraduate Institute of Dental Sciences Rohtak

Investigators

  • Study Director: Dr Sanjay Tewari, MDS, POSTGRADUATE INSTITUTE OF DENTAL SCIENCE,ROHTAK ,HARYANA,INDIA,124001

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 22, 2022

Primary Completion (Actual)

March 25, 2023

Study Completion (Estimated)

March 1, 2024

Study Registration Dates

First Submitted

January 13, 2024

First Submitted That Met QC Criteria

January 13, 2024

First Posted (Estimated)

January 24, 2024

Study Record Updates

Last Update Posted (Estimated)

January 24, 2024

Last Update Submitted That Met QC Criteria

January 13, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Akankshya Behera

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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