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

NCT ID: NCT07078110

Last Updated: 2025-07-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-18
• Study Completion Date: 2024-02-17

Brief Summary

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.

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.

Conditions

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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)

Group Type: OTHER

Material: Filtek Z250 (3M ESPE, USA)

Intervention Type: PROCEDURE

Group I (Incremental Technique):

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

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

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fatima Jinnah Dental College

OTHER

Sponsor Role: lead

Responsible Party

Maliha Hameed

Assistant Professor Paedodontics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dr Maliha Naveed Assistant Professor

Role: PRINCIPAL_INVESTIGATOR

Bahria University Medical & Dental College

Locations

Fatima Jinnah Dental College, Hospital Karachi Pakistan

Karachi, , Pakistan

Countries

Pakistan

Other Identifiers

FEB-2017-OPR02

Identifier Type: -

Identifier Source: org_study_id