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

NCT07078110 | Completed

• 1 other identifier: FEB-2017-OPR02
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Anatomic form

  One year

• Colour match

  One year

• Marginal discolouration

  One year

• Marginal Adaptation

  One year

• Secondary caries

  One year

Study Arms (2)

Control Group

OTHER

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)

Experimental group

ACTIVE COMPARATOR

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

Interventions

Material: Filtek Z250 (3M ESPE, USA) PROCEDURE

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

Control Group

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

Experimental group

Eligibility Criteria

• Age: 15 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fatima Jinnah Dental College: lead

Study Sites (1)

Fatima Jinnah Dental College, Hospital Karachi Pakistan

Karachi, Pakistan

Location

Related Publications (1)

• Naveed M, Ahmed MA, Syed AUY, Saqib M, Ali M, Jouhar R, Faheemuddin M, Umer MF. Comparative evaluation of clinical performance of bulk-fill composites with incrementally layered conventional composites. BMC Oral Health. 2025 Dec 5;26(1):55. doi: 10.1186/s12903-025-07453-6.

  PMID: 41345621 DERIVED

Study Officials

• Dr Maliha Naveed Assistant Professor

  Bahria University Medical & Dental College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor Paedodontics

Study Record Dates

• First Submitted: July 2, 2025
• First Posted: July 22, 2025
• Study Start: July 18, 2021
• Primary Completion: January 17, 2023
• Study Completion: February 17, 2024
• Last Updated: July 22, 2025

Record last verified: 2024-05

Locations

PA (1)