AzTrials
AzTrials

Postoperative SensitivityILCVSBFCNCT07078110

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

A study testing Material: Filtek Z250 (3M ESPE, USA) and Material: Filtek Bulk-Fill Restorative (FBF), 3M ESPE, USA in people with Postoperative Sensitivity and Anatomic Form of the Restoration, run by Fatima Jinnah Dental College at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 15 to 50 yearsHealthy volunteers can take part
What is being tested?
Material: Filtek Z250 (3M ESPE, USA) and Material: Filtek Bulk-Fill Restorative (FBF), 3M ESPE, USA
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 sitePakistan
Study dates
18 Jul 2021to 17 Feb 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • 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.

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

Pakistan1 site
  • Fatima Jinnah Dental College, Hospital Karachi Pakistan

    Karachi

Other trials in Pakistan

About this study

Official title: 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.

Read the 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.

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

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Material: Filtek Z250 (3M ESPE, USA)Procedure or surgery

    Group I (Incremental Technique):

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

  • Material: Filtek Bulk-Fill Restorative (FBF), 3M ESPE, USAProcedure or surgery

    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.

Study groups in NCT07078110
Study groupRoleWhat they receive
Control GroupOtherControl Group: Group I (Incremental Technique): Applied in 2 mm incremental layers, light-cured for 40 seconds per increment Material: Filtek Z250 (3M ESPE, USA)
Receives: Procedure: Material: Filtek Z250 (3M ESPE, USA)
Experimental groupActive comparatorGroup 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
Receives: Procedure: Material: Filtek Bulk-Fill Restorative (FBF), 3M ESPE, USA

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: One year

Secondary outcomes (6)
  1. 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

    Measured: One year

  2. Colour match

    Evaluates how well the restoration blends with the surrounding natural tooth color.

    Alfa: Matches tooth Bravo: Acceptable mismatch Charlie: Unacceptable mismatch

    Measured: One year

  3. 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

    Measured: One year

  4. 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

    Measured: One year

  5. Secondary caries

    Examines the presence of new decay around the restoration, indicating potential failure.

    Alfa: No caries present Charlie: Caries present

    Measured: One year

  6. 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

    Measured: One year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jul 2025
  2. Study start18 Jul 2021
  3. Primary completion17 Jan 2023
  4. Study completion17 Feb 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
Single blind
Who is masked
Participant
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07078110
Sponsor's protocol ID
FEB-2017-OPR02
Acronym
ILCVSBFC
Status last verified
May 2024
First submitted
2 Jul 2025
Last updated
22 Jul 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 41345621

Questions about this trial

What is this clinical trial studying?

A study testing Material: Filtek Z250 (3M ESPE, USA) and Material: Filtek Bulk-Fill Restorative (FBF), 3M ESPE, USA in people with Postoperative Sensitivity and Anatomic Form of the Restoration, run by Fatima Jinnah Dental College at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postoperative senstivity (time frame: One year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07078110, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2025; AzTrials last refreshed its copy on 7 Nov 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in