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Active, Not Recruiting

NCT Number: NCT07673952

Effect on Placement Tecnique of Bulkfill Composite

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Dental Caries Dental Restoration Failure Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hacettepe University Faculty of Dentistry

Ankara, 06100, Turkey (Türkiye)

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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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Treatment and study plan

bulk tecnique

Procedure

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

incrementally technique

Procedure

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Official study title

Clinical Evaluation of Bulkfill-Composite Restorations Placed Using Different Techniques

Important dates

Study start
2019
Primary completion
2027
Study completion
2029
First posted
Jun 29, 2026
Registry last updated
Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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