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Comparative Evaluation of Clinical Performance of Bulk-Fill Composites With Incrementally Layered Conventional Composites (ILCVSBFC)

F

Fatima Jinnah Dental College

Status

Completed

Conditions

Anatomic Form of the Restoration
Marginal Adaptation
Retention
Marginal Discolouration
Secondary Caries
Postoperative Sensitivity
Colour Match of the Restoration

Treatments

Procedure: Material: Filtek Bulk-Fill Restorative (FBF), 3M ESPE, USA
Procedure: Material: Filtek Z250 (3M ESPE, USA)

Study type

Interventional

Funder types

Other

Identifiers

NCT07078110
FEB-2017-OPR02

Details and patient eligibility

About

This study aimed to compare the clinical effectiveness of bulk-fill composites with conventionally layered incremental composites in Class I cavities using modified USPHS criteria. Fifty patients were selected based on sample size calculations. Each patient received two restorations, one from each group. Group I received incremental layering composite restorations, while Group II received bulk-fill composite restorations. Group I restorations were placed on the right side, and Group II restorations were placed on the left side. A single trained operator placed all restorations. After one year, the restorations were evaluated using modified USPHS criteria. Periapical radiographs were taken, and postoperative sensitivity was assessed using cold testing (ethyl chloride spray), with pain responses recorded using the Visual Analogue Scale.

Full description

This study aimed to compare the clinical effectiveness of bulk-fill composites with conventionally layered incremental composites in Class I cavities using modified USPHS criteria. Patients aged 15 to 50 years of either gender visiting Fatima Jinnah Dental College and Hospital OPD who fulfilled the inclusion criteria (vital first and second molar teeth with Class I cavities having a depth of 3-4mm) were recruited in the study from July 2021 to January 2023. Fifty patients were selected based on sample size calculations. Each patient received two restorations, one from each group. Group I received incremental layering composite restorations, while Group II received bulk-fill composite restorations. Group I restorations were placed on the right side, and Group II restorations were placed on the left side. A single trained operator placed all restorations. After one year, the restorations were evaluated using modified USPHS criteria. Periapical radiographs were taken, and postoperative sensitivity was assessed using cold testing (ethyl chloride spray), with pain responses recorded using the Visual Analogue Scale.

Eligibility Criteria:

Inclusion Criteria:

Patients aged 15 to 50 years, of either gender. Visiting Fatima Jinnah Dental College and Hospital OPD. Vital first and second molar teeth with Class I cavities, 3-4 mm in depth.

Exclusion Criteria:

Patients with xerostomia or bruxism (assessed via medical history). Teeth with irreversible pulpitis or necrotic pulps. Previously restored or periodontally compromised teeth.

Confounding Variables:

Confounding factors like xerostomia and bruxism were excluded. Factors like smoking and soft drink consumption were considered during analysis.

Preoperative Assessment Electric pulp tester was used to evaluate tooth vitality. Adjacent tissues were clinically examined. Baseline data included age, sex, tooth treated, and caries depth.

Operative Procedure Local anesthesia was administered using 2% lidocaine (1.8 ml cartridge). Rubber dam isolation was employed for moisture control. Cavity preparation was done using a straight fissure bur in a high-speed handpiece.

Carious dentin was removed using a spoon excavator or slow-speed tungsten carbide bur.

Etching followed by application of 3M Singlebond Universal adhesive for 35 seconds, gently air-dried, then light-cured for 20 seconds.

Restoration Groups

Each participant received two restorations-one from each group-to allow for intra-individual comparison:

Group I (Incremental Technique):

Material: Filtek Z250 (3M ESPE, USA) Applied in 2 mm incremental layers, light-cured for 40 seconds per increment.

Group II (Bulk-Fill Technique):

Material: Filtek Bulk-Fill Restorative (FBF), 3M ESPE, USA Applied in a single increment (up to 4 mm) and light-cured for 40 seconds.

Group I restorations were placed on the right side, and Group II on the left side. All restorations were placed by a single trained operator over 6 months. The participants were blinded to the type of restoration used.

Follow-Up and Evaluation Restorations were evaluated 1 year post-placement by a principal investigator under a dental operating light using flat-surfaced mouth mirrors and dental explorers.

Evaluation followed modified USPHS criteria, assessing:

Anatomic form Color match Marginal discoloration Marginal adaptation Secondary caries Retention

STATISTICAL ANALYSIS:

Descriptive statistics and post-stratification Chi-square tests were performed.

Enrollment

50 patients

Sex

All

Ages

15 to 50 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Eligibility Criteria

Inclusion Criteria:

Patients aged 15 to 50 years, of either gender. Visiting Fatima Jinnah Dental College and Hospital OPD. Vital first and second molar teeth with Class I cavities, 3-4 mm in depth.

Exclusion Criteria:

Patients with xerostomia or bruxism (assessed via medical history). Teeth with irreversible pulpitis or necrotic pulps. Previously restored or periodontally compromised teeth.

Confounding Variables:

Confounding factors like xerostomia and bruxism were excluded. Factors like smoking and soft drink consumption were considered during analysis.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

Single Blind

50 participants in 2 patient groups

Control Group
Other group
Description:
Control Group: Group I (Incremental Technique): Applied in 2 mm incremental layers, light-cured for 40 seconds per increment Material: Filtek Z250 (3M ESPE, USA)
Treatment:
Procedure: Material: Filtek Z250 (3M ESPE, USA)
Experimental group
Active Comparator group
Description:
Group II (Bulk-Fill Technique): Applied in a single increment (up to 4 mm) and light-cured for 40 seconds. Material: Filtek Bulk-Fill Restorative (FBF), 3M ESPE, USA
Treatment:
Procedure: Material: Filtek Bulk-Fill Restorative (FBF), 3M ESPE, USA

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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