Clinical Performance of a Preheated Thermoviscous Bulk-Fill Composite and Two Different Indirect Composite Systems in Primary Molars: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Fédération Dentaire Internationale (FDI) criteria
Study Overview
Brief Summary
The aim of this study was to compare the clinical performance of direct restorations with two different indirect composite systems in primary teeth.
Detailed Description
The aim of this study was to compare the clinical performance of a thermoviscous bulk-fill composite used in direct restorations with two different indirect composite systems in primary teeth. This randomized, controlled, assessor-blind, parallel-group design in vivo study included 158 teeth from 73 patients aged 4-10 years. The teeth were allocated into three groups: direct thermoviscous bulk-fill composite, indirect nano-hybrid composite inlay system, and indirect nano-hybrid modular composite system. Clinical evaluations were performed according to FDI criteria at 6- and 12-month follow-up, and survival comparisons were conducted.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
The study was carried out as a one-blinded trial, which the outcomes assessor was unaware of what material was applied to each tooth. No blinding was done during the treatment period because all treatments were performed by one dentist.
Eligibility Criteria
- Ages
- 4 Years to 10 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •children aged between 4 and 10 years,
- •classified as ASA I according to the American Society of Anesthesiologists (i.e., healthy individuals without systemic disease except for conditions not affecting general health),
- •demonstrating cooperative behavior corresponding to Frankl Behavior Rating Scale scores of 3 (positive) or 4 (definitely positive).
- •Only patients presenting with Angle Class I occlusion
- •demonstrating bilateral, balanced mastication were included in the study.
- •Teeth included in the study were required to present with Class II (MO/DO) cavities and to have an antagonist and proximal contact.
- •According to the International Caries Detection and Assessment System II (ICDAS II), teeth with scores of 4, 5, or 6 were included.
- •In addition, only teeth with a plaque index score of 0 (no plaque) or 1 (plaque not visible to the naked eye but detectable with a probe at the gingival margin)
- •a gingival index score of 0 (healthy gingiva, no inflammation) were selected
Exclusion Criteria
- •patients who do not meet the inclusion criteria
- •teeth that do not meet the inclusion criteria
- •Teeth showing internal and external resorption on radiographic examination
- •Patients/guardians who declined to participate in the study and participants who did not sign the consent form
Arms & Interventions
direct thermoviscous bulk-fill composite
Direct composite restorations were performed using heated composite material in accordance with the manufacturer's recommendations.
Intervention: Fédération Dentaire Internationale (FDI) criteria. (Other)
direct thermoviscous bulk-fill composite
Direct composite restorations were performed using heated composite material in accordance with the manufacturer's recommendations.
Intervention: survival comparison (Other)
indirect nano-hybrid composite inlay system
Indirect restorations were fabricated extraorally using incremental layering techniques (≤2 mm) and polymerized using LED light-curing units. Additional post-curing procedures were performed according to manufacturers' instructions.
Intervention: Fédération Dentaire Internationale (FDI) criteria. (Other)
indirect nano-hybrid composite inlay system
Indirect restorations were fabricated extraorally using incremental layering techniques (≤2 mm) and polymerized using LED light-curing units. Additional post-curing procedures were performed according to manufacturers' instructions.
Intervention: survival comparison (Other)
indirect nano-hybrid modular composite system
Indirect restorations were fabricated extraorally using incremental layering techniques (≤2 mm) and polymerized using a dual-mode laboratory polymerization unit (Labolight DUO, GC, Tokyo, Japan). Additional post-curing procedures were performed according to manufacturers' instructions.
Intervention: Fédération Dentaire Internationale (FDI) criteria. (Other)
indirect nano-hybrid modular composite system
Indirect restorations were fabricated extraorally using incremental layering techniques (≤2 mm) and polymerized using a dual-mode laboratory polymerization unit (Labolight DUO, GC, Tokyo, Japan). Additional post-curing procedures were performed according to manufacturers' instructions.
Intervention: survival comparison (Other)
Outcomes
Primary Outcomes
Fédération Dentaire Internationale (FDI) criteria
Time Frame: Clinical evaluations were performed according to FDI criteria at 6- and 12-month follow-up
The clinical performance of restorations was evaluated using Fédération Dentaire Internationale (FDI) criteria. Restorations were assessed across functional (fracture and retention, marginal adaptation), biological (postoperative sensitivity, recurrent caries, tooth integrity, and periodontal response), and esthetic (surface polish, marginal and surface staining) domains using a five-point scale. Scores of 1-3 were considered clinically acceptable, whereas scores of 4-5 were considered clinically unacceptable and indicative of failure
Secondary Outcomes
- survival comparison(6- and 12-month follow-up)
Investigators
Ebru KUCUKYİLMAZ
Prof. Dr.
Izmir Katip Celebi University