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.
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
- Conditions the study is for
- Postoperative Sensitivity, Anatomic Form of the Restoration, Colour Match of the Restoration
- 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
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.
- Conditions
- Postoperative Sensitivity, Anatomic Form of the Restoration, Colour Match of the Restoration, Marginal Discolouration, Marginal Adaptation, Secondary Caries
- 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 group | Role | What they receive |
|---|---|---|
| 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) Receives: 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 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.
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)
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
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
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
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
Secondary caries
Examines the presence of new decay around the restoration, indicating potential failure.
Alfa: No caries present Charlie: Caries present
Measured: 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
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2025
- Study start18 Jul 2021
- Primary completion17 Jan 2023
- Study completion17 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative SensitivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Fatima Jinnah Dental College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maliha Hameed, Fatima Jinnah Dental College
- Investigators
- Dr Maliha Naveed Assistant Professor, Principal investigator, Bahria University Medical & Dental College
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
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Clinical Performance of Bulk-Fill Composites With Incrementally Layered Conventional Composites: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07078110
- Acronym / sponsor ID
- ILCVSBFC / FEB-2017-OPR02
- Conditions
- Postoperative Sensitivity, Anatomic Form of the Restoration, Colour Match of the Restoration, Marginal Discolouration, Marginal Adaptation, Secondary Caries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Fatima Jinnah Dental CollegeUniversity, hospital or other
- Study start
- 18 Jul 2021 (actual)
- Primary completion
- 17 Jan 2023 (actual)
- Study completion
- 17 Feb 2024 (actual)
- First posted
- 22 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Other | Procedure: Material: Filtek Z250 (3M ESPE, USA)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) |
| Experimental group | Active comparator | Procedure: Material: Filtek Bulk-Fill Restorative (FBF), 3M ESPE, USAGroup 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 |
Who may qualify
- Ages
- 15 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- Patients with xerostomia or bruxism (assessed via medical history). Teeth with irreversible pulpitis or necrotic pulps. Previously restored or periodontally compromised teeth.
- Confounding factors like xerostomia and bruxism were excluded. Factors like smoking and soft drink consumption were considered during analysis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | Control Group |
| Material: Filtek Bulk-Fill Restorative (FBF), 3M ESPE, USAGroup 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. | Procedure or surgery | Experimental group |
Primary outcome
Postoperative senstivity
Time frame: One year
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
6 secondary outcomes
Anatomic form
Time frame: One year
Colour match
Time frame: One year
Marginal discolouration
Time frame: One year
Marginal Adaptation
Time frame: One year
Secondary caries
Time frame: One year
Retention
Time frame: One year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2025.
- Derived from this study: PubMed 41345621Naveed 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr Maliha Naveed Assistant Professor principal investigator
Bahria University Medical & Dental College
1 site in 1 country: see every site and its status.
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.