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

Comparative Evaluation of Clinical Performance of Bulk-Fill Composites With Incrementally Layered Conventional Composites: A Randomized Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Retention; Secondary Caries; Postoperative Sensitivity; Anatomic Form of the Restoration; Colour Match of the Restoration; Marginal Discolouration; Marginal Adaptation
• Intervention / Treatment: Procedure: Material: Filtek Z250 (3M ESPE, USA); Procedure: Material: Filtek Bulk-Fill Restorative (FBF), 3M ESPE, USA

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Karachi, Pakistan
    • Fatima Jinnah Dental College, Hospital Karachi Pakistan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Control Group; 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)	Procedure: Material: Filtek Z250 (3M ESPE, USA); Group I (Incremental Technique): Material: Filtek Z250 (3M ESPE, USA) Applied in 2 mm incremental layers, light-cured for 40 seconds per increment.
Active Comparator: Experimental group; 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	Procedure: Material: Filtek Bulk-Fill Restorative (FBF), 3M ESPE, USA; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative senstivity	Postoperative sensitivity was assessed using ethyl chloride spray and scored using the Visual Analogue Scale (VAS): 0 = No pain 1-3 cm = Mild pain 4-6 cm = Moderate pain 7-10 cm = Severe pain	One year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anatomic form	Assesses the restoration's shape and how well it conforms to the natural contours of the tooth. Alfa: Continuous Bravo: Slight discontinuity, clinically acceptable Charlie: Discontinuous, failure	One year
Colour match	Evaluates how well the restoration blends with the surrounding natural tooth color. Alfa: Matches tooth Bravo: Acceptable mismatch Charlie: Unacceptable mismatch	One year
Marginal discolouration	Examines the presence of any dark lines or discoloration along the margins of the restoration. Alfa: No discoloration Bravo: Discoloration without Charlie: Discoloration with penetration in pulpal direction	One year
Marginal Adaptation	Evaluates the fit of the restoration at the margins, looking for any gaps or discrepancies. Alfa: Closely adapted, no visible crevice Bravo: Visible crevice, explorer will penetrate Charlie: Crevice in which dentin is exposed	One year
Secondary caries	Examines the presence of new decay around the restoration, indicating potential failure. Alfa: No caries present Charlie: Caries present	One year
Retention	Assesses whether the restoration remains firmly in place and hasn't fractured or dislodged. Alfa: No loss of restorative material Charlie: Any loss of restorative material	One year

Collaborators and Investigators

• Sponsor: Fatima Jinnah Dental College
• Investigators: Principal Investigator: Dr Maliha Naveed Assistant Professor, Bahria University Medical & Dental College

Study record dates

Study Major Dates

• Study Start (Actual): July 18, 2021
• Primary Completion (Actual): January 17, 2023
• Study Completion (Actual): February 17, 2024

Study Registration Dates

• First Submitted: July 2, 2025
• First Submitted That Met QC Criteria: July 13, 2025
• First Posted (Actual): July 22, 2025

Study Record Updates

• Last Update Posted (Actual): July 22, 2025
• Last Update Submitted That Met QC Criteria: July 13, 2025
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity
• Other Study ID Numbers: FEB-2017-OPR02

Drug and device information, study documents

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