Dental CariesNCT07673952
Effect on Placement Tecnique of Bulkfill Composite
A study testing bulk tecnique and incrementally technique in people with Dental Caries and Dental Restoration Failure, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
The objective of this study was to evaluate the clinical performance of a bulk-fill composite resin (3M ESPE Filtek Bulk Fill, St Paul, MN, USA) in restorations placed in occlusal cavities by comparing different placement techniques (bulk vs. incremental) using modified USPHS criteria. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries, Dental Restoration Failure
- What is being tested?
- bulk tecnique and incrementally technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2019to 1 Jan 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Inclusion Criteria:Good general health, 18 years of age or older, Acceptable oral hygiene level, Present at least 20 teeth in the occlusion, Have at least two or four posterior teeth in need of restorative treatment. Have carious lesions, defective restorations replacement due to esthetic reasons).
Exclusion Criteria:Poor oral hygiene, Having possible allergy to resin-based restorations, Advanced periodontal disease, Xerostomia, Pregnancy or breastfeeding, Severe systemic disease, Diagnosis of bruxism, Bleaching treatment or orthodontic treatment.
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Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hacettepe University Faculty of Dentistry
Ankara, 06100
About this study
Official title: Clinical Evaluation of Bulkfill-Composite Restorations Placed Using Different Techniques
The objective of this study was to evaluate the clinical performance of a bulk-fill composite resin (3M ESPE Filtek Bulk Fill, St Paul, MN, USA) in restorations placed in occlusal cavities by comparing different placement techniques (bulk vs. incremental) using modified USPHS criteria.
Read the detailed description
A total of 50 patients (n=108), each with two or four occlusal cavities having a depth of at least 4 mm, were randomly assigned to two groups. A bite-wing radiograph was taken for each tooth. The Single Bond Universal Adhesive (3M, ESPE, St Paul, MN, USA) was applied using the selective-enamel-etch mode. One tooth from each patient was restored using the bulk technique while the other was restored using the incremental technique. All restorations were placed by a single operator. Two experienced and calibrated examiners who were blinded to the placement technique evaluated the restorations at one week and subsequently at 6-, 12-, 24-, 36-, and 48-month follow-ups according to modified USPHS criteria. Spontaneous post-operative sensitivity was assessed through restorative procedures up to 24 hours post-treatment, as well as one week and six months later utilizing a Visual Analog Scale (VAS). The chi-square test was employed for comparing both restoration techniques within each category (p<0.05).
- Conditions
- Dental Caries, Dental Restoration Failure
- Being tested
- bulk tecnique, incrementally technique
- Keywords
- Bulkfill resin composite, post-operative sensitivity, universal adhesive
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bulk tecniqueProcedure or surgery
The bulkfill resin composite was placed bulk tecnique and light cured with the same LED for 20 s by the same operator.
incrementally techniqueProcedure or surgery
The bulkfill resin composite was placed incrementally (2mm) and light cured with the same LED for 20 s by the same operator.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Other | Bulk-filling placement technique Receives: Procedure: bulk tecnique |
| Group 2 | Other | Incremental placement technique Receives: Procedure: incrementally technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
RETENTİON
The retention criterion determines how long a restorative material functions in the oral environment, it is the most important criterion that shows the success of the material. Alpha: The restoration is present. Charlie: The restoration is absent.
Measured: From baseline to 6 year the change of restorations was evaluated
Marginal Discoloration
The marginal discoloration that occur at the edge staining restoration boundaries are generally thought to be due to microleakage. Alpha: No discoloration at margins. Bravo: Shallow discoloration, clinically acceptable. Charlie: Deep discoloration clinically unacceptable.
Measured: From baseline to 6 year the change of restorations was evaluated
Marginal Adaptation
Marginal adaptation is achieved by fully ensuring the integrity of the tooth-restoration joint border. Alpha: Restoration is closely adapted to the tooth. Bravo: Visible evidence of a crevice along the margin, dentin not exposed, clinically acceptable. Charlie: Explorer penetrates into crevice, dentin is exposed; clinically unacceptable.
Measured: From baseline to 6 year the change of restorations was evaluated
Color match
Color match is the evaluation of the restoration according to the darkening or lightening of the color, taking into account the tooth tissue surrounding restoration. Alpha:Matches tooth. Bravo: Acceptable mismatch. Charlie:Unacceptable mismatch.
Measured: From baseline to 2 year the change of restorations was evaluated
Post-op Hypersensitivity
Determination of sensitivity after restorations are placed. Alpha: Absent. Charlie: Present; clinically unacceptable.
Measured: From baseline to 6 year the change of restorations was evaluated
Secondary caries
Secondary caries is the progression of caries in the tooth tissue adjacent to the restorations. Caries formation means restoration failure. Alpha: Absent. Charlie: Present; clinically unacceptable.
Measured: From baseline to 6 year the change of restorations was evaluated
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2026
- Study start1 Jan 2019
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- A total of 108 occlusal carious lesions in 50 patients will be randomly divided into two groups. Bulkfill resin composite will be restored with Filtek Bulk Fill placed with bulk-filling or incremental technique. Universal Adhesive was applied in a selective-etch mode according to the manufacturer's instructions. One tooth was restored using the bulk-filling placement technique, while another was restored using the incremental placement technique. The placement technique for the bulk-fill composite was determined via a coin toss for the respective teeth.This randomization was blinded to participants and evaluators. It was not known which placement technique was applied to which teeth of the participants.
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, A Ruya Yazici, Hacettepe University
- Investigators
- A. Ruya Yazici, Professor, Study director, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07673952
- Sponsor's protocol ID
- KA-180052
- Status last verified
- Jun 2026
- First submitted
- 23 Jun 2026
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Study not completed
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Bulkfill-Composite Restorations Placed Using Different Techniques
- ClinicalTrials.gov ID
- NCT07673952
- Acronym / sponsor ID
- KA-180052
- Conditions
- Dental Caries, Dental Restoration Failure
- Keywords
- Bulkfill resin composite, post-operative sensitivity, universal adhesive
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2029 (estimated)
- First posted
- 29 Jun 2026 (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.
The objective of this study was to evaluate the clinical performance of a bulk-fill composite resin (3M ESPE Filtek Bulk Fill, St Paul, MN, USA) in restorations placed in occlusal cavities by comparing different placement techniques (bulk vs. incremental) using modified USPHS criteria.
Detailed description
A total of 50 patients (n=108), each with two or four occlusal cavities having a depth of at least 4 mm, were randomly assigned to two groups. A bite-wing radiograph was taken for each tooth. The Single Bond Universal Adhesive (3M, ESPE, St Paul, MN, USA) was applied using the selective-enamel-etch mode. One tooth from each patient was restored using the bulk technique while the other was restored using the incremental technique. All restorations were placed by a single operator. Two experienced and calibrated examiners who were blinded to the placement technique evaluated the restorations at one week and subsequently at 6-, 12-, 24-, 36-, and 48-month follow-ups according to modified USPHS criteria. Spontaneous post-operative sensitivity was assessed through restorative procedures up to 24 hours post-treatment, as well as one week and six months later utilizing a Visual Analog Scale (VAS). The chi-square test was employed for comparing both restoration techniques within each category (p<0.05).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A total of 108 occlusal carious lesions in 50 patients will be randomly divided into two groups. Bulkfill resin composite will be restored with Filtek Bulk Fill placed with bulk-filling or incremental technique. Universal Adhesive was applied in a selective-etch mode according to the manufacturer's instructions. One tooth was restored using the bulk-filling placement technique, while another was restored using the incremental placement technique. The placement technique for the bulk-fill composite was determined via a coin toss for the respective teeth.This randomization was blinded to participants and evaluators. It was not known which placement technique was applied to which teeth of the participants.
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Other | Procedure: bulk tecniqueBulk-filling placement technique |
| Group 2 | Other | Procedure: incrementally techniqueIncremental placement technique |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
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 |
|---|---|---|
| bulk tecniqueThe bulkfill resin composite was placed bulk tecnique and light cured with the same LED for 20 s by the same operator. | Procedure or surgery | Group 1 |
| incrementally techniqueThe bulkfill resin composite was placed incrementally (2mm) and light cured with the same LED for 20 s by the same operator. | Procedure or surgery | Group 2 |
Primary outcome
RETENTİON
Time frame: From baseline to 6 year the change of restorations was evaluated
The retention criterion determines how long a restorative material functions in the oral environment, it is the most important criterion that shows the success of the material. Alpha: The restoration is present. Charlie: The restoration is absent.
Marginal Discoloration
Time frame: From baseline to 6 year the change of restorations was evaluated
The marginal discoloration that occur at the edge staining restoration boundaries are generally thought to be due to microleakage. Alpha: No discoloration at margins. Bravo: Shallow discoloration, clinically acceptable. Charlie: Deep discoloration clinically unacceptable.
Marginal Adaptation
Time frame: From baseline to 6 year the change of restorations was evaluated
Marginal adaptation is achieved by fully ensuring the integrity of the tooth-restoration joint border. Alpha: Restoration is closely adapted to the tooth. Bravo: Visible evidence of a crevice along the margin, dentin not exposed, clinically acceptable. Charlie: Explorer penetrates into crevice, dentin is exposed; clinically unacceptable.
Color match
Time frame: From baseline to 2 year the change of restorations was evaluated
Color match is the evaluation of the restoration according to the darkening or lightening of the color, taking into account the tooth tissue surrounding restoration. Alpha:Matches tooth. Bravo: Acceptable mismatch. Charlie:Unacceptable mismatch.
Post-op Hypersensitivity
Time frame: From baseline to 6 year the change of restorations was evaluated
Determination of sensitivity after restorations are placed. Alpha: Absent. Charlie: Present; clinically unacceptable.
Secondary caries
Time frame: From baseline to 6 year the change of restorations was evaluated
Secondary caries is the progression of caries in the tooth tissue adjacent to the restorations. Caries formation means restoration failure. Alpha: Absent. Charlie: Present; clinically unacceptable.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Individual participant dataSharing planned: Undecided. Study not completed
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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.
A. Ruya Yazici, Professor study director
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bulk tecnique and incrementally technique in people with Dental Caries and Dental Restoration Failure, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: under way, not looking for participants, as of the sponsor's last update on 29 Jun 2026. 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 Turkey (Türkiye). 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?
This study is still under way. Results are not available in the source record yet.
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?
RETENTİON (time frame: From baseline to 6 year the change of restorations was evaluated). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jun 2026.