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Effect on Placement Tecnique of Bulkfill Composite

H

Hacettepe University

Status

Active, not recruiting

Conditions

Dental Caries
Dental Restoration Failure

Treatments

Procedure: bulk tecnique
Procedure: incrementally technique

Study type

Interventional

Funder types

Other

Identifiers

NCT07673952
KA-180052

Details and patient eligibility

About

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.

Full 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).

Enrollment

50 patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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 design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

50 participants in 2 patient groups

Group 1
Other group
Description:
Bulk-filling placement technique
Treatment:
Procedure: bulk tecnique
Group 2
Other group
Description:
Incremental placement technique
Treatment:
Procedure: incrementally technique

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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