Composite Restorations in Primary Molars

NCT07761897 | Completed

• 1 other identifier: 2021/86
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Restoration; Caries; Dentin; Caries Class Ii

Keywords

caries; primary molars; thermoviscous bulk-fill composite; indirect composite restorations; clinical performance; FDI criteria

Outcome Measures

Primary Outcomes (1)

• Fédération Dentaire Internationale (FDI) criteria

  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

  Clinical evaluations were performed according to FDI criteria at 6- and 12-month follow-up

Secondary Outcomes (1)

• survival comparison

  6- and 12-month follow-up

Study Arms (3)

direct thermoviscous bulk-fill composite

EXPERIMENTAL

Direct composite restorations were performed using heated composite material in accordance with the manufacturer's recommendations.

Other: Fédération Dentaire Internationale (FDI) criteria.; Other: survival comparison

indirect nano-hybrid composite inlay system

EXPERIMENTAL

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.

Other: Fédération Dentaire Internationale (FDI) criteria.; Other: survival comparison

indirect nano-hybrid modular composite system

EXPERIMENTAL

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.

Other: Fédération Dentaire Internationale (FDI) criteria.; Other: survival comparison

Interventions

Fédération Dentaire Internationale (FDI) criteria. OTHER

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

direct thermoviscous bulk-fill composite; indirect nano-hybrid composite inlay system; indirect nano-hybrid modular composite system

survival comparison OTHER

For survival comparisons, restoration failure was defined as total or partial loss of the restoration or a clinically unacceptable score according to FDI criteria. Restorations maintaining acceptable clinical performance throughout the follow-up period were considered successful.

direct thermoviscous bulk-fill composite; indirect nano-hybrid composite inlay system; indirect nano-hybrid modular composite system

Eligibility Criteria

• Age: 4 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Izmir Katip Celebi University: lead

Study Sites (1)

Izmir Katip Celebi University

Izmir, Çiğli, 35640, Turkey (Türkiye)

Location

Related Publications (5)

• Soares BM, Barbosa MP, de Almeida RV, Jardim RN, da Silva EM. Marginal integrity and physicomechanical properties of a thermoviscous and regular bulk-fill resin composites. Clin Oral Investig. 2024 Aug 23;28(9):496. doi: 10.1007/s00784-024-05887-w.

  PMID: 39177835 BACKGROUND

• Jordaki D, Veress V, Kiss T, Szalma J, Frater M, Lempel E. Comparative Micro-CT Analysis of Internal Adaptation and Closed Porosity of Conventional Layered and Thermoviscous Bulk-Fill Resin Composites Using Total-Etch or Universal Adhesives. Polymers (Basel). 2025 Jul 27;17(15):2049. doi: 10.3390/polym17152049.

  PMID: 40808098 BACKGROUND

• Van Ende A, De Munck J, Lise DP, Van Meerbeek B. Bulk-Fill Composites: A Review of the Current Literature. J Adhes Dent. 2017;19(2):95-109. doi: 10.3290/j.jad.a38141.

  PMID: 28443833 BACKGROUND

• Opdam NJ, van de Sande FH, Bronkhorst E, Cenci MS, Bottenberg P, Pallesen U, Gaengler P, Lindberg A, Huysmans MC, van Dijken JW. Longevity of posterior composite restorations: a systematic review and meta-analysis. J Dent Res. 2014 Oct;93(10):943-9. doi: 10.1177/0022034514544217. Epub 2014 Jul 21.

  PMID: 25048250 BACKGROUND

• Kazeminia M, Abdi A, Shohaimi S, Jalali R, Vaisi-Raygani A, Salari N, Mohammadi M. Dental caries in primary and permanent teeth in children's worldwide, 1995 to 2019: a systematic review and meta-analysis. Head Face Med. 2020 Oct 6;16(1):22. doi: 10.1186/s13005-020-00237-z.

  PMID: 33023617 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Model Details: This randomized, controlled, parallel design, assessor-blind study was conducted under in vivo conditions to compare the clinical performance of direct and indirect restorations applied to carious primary molar teeth.

Study Record Dates

• First Submitted: August 4, 2026
• First Posted: August 12, 2026
• Study Start: March 1, 2022
• Primary Completion: January 15, 2024
• Study Completion: January 15, 2025
• Last Updated: August 12, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The plan will be shared following the completion of the research paper (approximately 1 month)
• Access Criteria: De-identified individual participant data (IPD) will be made available upon reasonable request following publication of the main results, in accordance with institutional and ethical regulations. Access will be granted to qualified researchers for non-commercial purposes.

Locations

TU (1)