Effect on Placement Tecnique of Bulkfill Composite

NCT07673952 | Active Not Recruiting

• 1 other identifier: KA-180052
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Caries; Dental Restoration Failure

Keywords

Bulkfill resin composite; post-operative sensitivity; universal adhesive

Outcome Measures

Primary Outcomes (6)

• 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.

  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.

  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.

  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.

  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.

  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.

  From baseline to 6 year the change of restorations was evaluated

Study Arms (2)

Group 1

OTHER

Bulk-filling placement technique

Procedure: bulk tecnique

Group 2

OTHER

Incremental placement technique

Procedure: incrementally technique

Interventions

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.

Group 1

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.

Group 2

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University Faculty of Dentistry

Ankara, 06100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• A. Ruya Yazici, Professor

  Hacettepe University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Model Details: 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.

Study Record Dates

• First Submitted: June 23, 2026
• First Posted: June 29, 2026
• Study Start: January 1, 2019
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2029
• Last Updated: June 29, 2026

Record last verified: 2026-06

Locations

TU (1)