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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07078110
Acronym
ILCVSBFC
Enrollment
50
Registered
2025-07-22
Start date
2021-07-18
Completion date
2024-02-17
Last updated
2025-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

PROCEDUREMaterial: 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.

PROCEDUREMaterial: 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.

Sponsors

Fatima Jinnah Dental College
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
15 Years to 50 Years
Healthy volunteers
Yes

Inclusion 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.

Design outcomes

Primary

MeasureTime frameDescription
Postoperative senstivityOne yearPostoperative 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

Secondary

MeasureTime frameDescription
Anatomic formOne yearAssesses 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
Colour matchOne yearEvaluates how well the restoration blends with the surrounding natural tooth color. Alfa: Matches tooth Bravo: Acceptable mismatch Charlie: Unacceptable mismatch
Marginal discolourationOne yearExamines 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
Secondary cariesOne yearExamines the presence of new decay around the restoration, indicating potential failure. Alfa: No caries present Charlie: Caries present
RetentionOne yearAssesses 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
Marginal AdaptationOne yearEvaluates 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

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026