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RestorationComposite RestNCT07761897

Composite Restorations in Primary Molars

A study testing Fédération Dentaire Internationale (FDI) criteria. and survival comparison in people with Restoration and Caries; Dentin, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of this study was to compare the clinical performance of direct restorations with two different indirect composite systems in primary teeth. Read more about this study

Who is it for?
Ages 4 to 10 yearsHealthy volunteers can take part
Conditions the study is for
Restoration, Caries; Dentin, Caries Class Ii
What is being tested?
Fédération Dentaire Internationale (FDI) criteria. and survival comparison
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Mar 2022to 15 Jan 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 4 to 10 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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.
Show all 9Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Izmir Katip Celebi University

    Izmir, Çiğli, 35640

Other trials in Turkey (Türkiye)

About this study

Official title: Clinical Performance of a Preheated Thermoviscous Bulk-Fill Composite and Two Different Indirect Composite Systems in Primary Molars: A Randomized Controlled Trial

The aim of this study was to compare the clinical performance of direct restorations with two different indirect composite systems in primary teeth.

Read the 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.

Being tested
Fédération Dentaire Internationale (FDI) criteria., survival comparison
Keywords
caries, primary molars, thermoviscous bulk-fill composite, indirect composite restorations, clinical performance, FDI criteria

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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

  • survival comparisonOther

    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.

Study groups in NCT07761897
Study groupRoleWhat they receive
direct thermoviscous bulk-fill compositeExperimentalDirect composite restorations were performed using heated composite material in accordance with the manufacturer's recommendations.
Receives: Other: Fédération Dentaire Internationale (FDI) criteria.; Other: survival comparison
indirect nano-hybrid composite inlay systemExperimentalIndirect 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.
Receives: Other: Fédération Dentaire Internationale (FDI) criteria.; Other: survival comparison
indirect nano-hybrid modular composite systemExperimentalIndirect 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.
Receives: Other: Fédération Dentaire Internationale (FDI) criteria.; Other: survival comparison

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

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

Secondary outcomes (1)

  1. survival comparison

    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.

    Measured: 6- and 12-month follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Aug 2026
  2. Study start1 Mar 2022
  3. Primary completion15 Jan 2024
  4. Study completion15 Jan 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07761897
Sponsor's protocol ID
2021/86
Acronym
Composite Rest
Status last verified
Aug 2026
First submitted
4 Aug 2026
Last updated
12 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: study plan will be shared

Publications

  • 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.

    PubMed 39177835

  • 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.

    PubMed 40808098

  • 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.

    PubMed 28443833

  • 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.

    PubMed 25048250

  • 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.

    PubMed 33023617

Questions about this trial

What is this clinical trial studying?

A study testing Fédération Dentaire Internationale (FDI) criteria. and survival comparison in people with Restoration and Caries; Dentin, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fédération Dentaire Internationale (FDI) criteria (time frame: Clinical evaluations were performed according to FDI criteria at 6- and 12-month follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07761897, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.

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