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Effect on Placement Tecnique of Bulkfill Composite

Clinical Evaluation of Bulkfill-Composite Restorations Placed Using Different Techniques

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07673952
Enrollment
50
Registered
2026-06-29
Start date
2019-01-01
Completion date
2029-01-01
Last updated
2026-06-29

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

Conditions

Dental Caries, Dental Restoration Failure

Keywords

Bulkfill resin composite, post-operative sensitivity, universal adhesive

Brief 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.

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).

Interventions

PROCEDUREbulk tecnique

The bulkfill resin composite was placed bulk tecnique and light cured with the same LED for 20 s by the same operator.

PROCEDUREincrementally technique

The bulkfill resin composite was placed incrementally (2mm) and light cured with the same LED for 20 s by the same operator.

Sponsors

Hacettepe University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

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. \-

Design outcomes

Primary

MeasureTime frameDescription
RETENTİONFrom baseline to 6 year the change of restorations was evaluatedThe 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 DiscolorationFrom baseline to 6 year the change of restorations was evaluatedThe 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 AdaptationFrom baseline to 6 year the change of restorations was evaluatedMarginal 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 matchFrom baseline to 2 year the change of restorations was evaluatedColor 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 HypersensitivityFrom baseline to 6 year the change of restorations was evaluatedDetermination of sensitivity after restorations are placed. Alpha: Absent. Charlie: Present; clinically unacceptable.
Secondary cariesFrom baseline to 6 year the change of restorations was evaluatedSecondary 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.

Countries

Turkey (Türkiye)

Contacts

STUDY_DIRECTORA. Ruya Yazici, Professor

Hacettepe University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 30, 2026