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NCT01369108 · ClinicalTrials.gov registry record · NA

Clinical Study on a New Flowable Composite as a Restorative in Adult Teeth

A NA study of Dental Caries, sponsored by Solventum US.

Completed
Registry status
NA
Development phase
60
Enrollment target
1
Study location

NCT01369108: Completed NA study of Dental Caries, sponsored by Solventum US.

NCT01369108 is a NA study of Dental Caries that has completed, run by Solventum US. The registered enrollment target is 60 participants, below the 720-participant average among 30 other Dental Caries trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01369108, a NA study of Dental Caries, has completed, sponsored by Solventum US.

COMPLETED
Registry status
NA
Development phase
60 participants
Enrollment target
1
Study location

Study Summary

Study hypothesis: a new, low polymerization stress flowable composite performs no differently to a conventional, highly filled composite filling material when used as a restorative in small cavities in back teeth. Study will evaluate the clinical performance of a low shrinking flowable composite filling material, compared with a conventional, highly filled composite restorative when used to permanently fill small cavities in molar and premolar teeth in adult patients.

Primary Outcome

Clinical performance reported on 6 parameters as the % of teeth with perfect scores ("A" rating). Cvar \& Ryge scores measure 6 parameters: Anatomic form (rated A,B= satisfactory, C=unsatisfactory); Color Match (A=match, B=mismatch, but within normal, C=mismatch outside normal); Marginal Adaptation (A=no visible crevice, B=no exposure of dentin, C=defect to enamel-dentine junction, D= fracture, missing); Marginal Discoloration (A=none, B= marginal discoloration, C=marginal discoloration to pulp

Conditions Studied

Interventions

  • DEVICE Flowable composite
  • DEVICE Conventional composite restorative

Study Locations (1)

Alabama

  • University of Alabama at Birmingham School of Dentistry, 605 School of Dentistry Building, 1919 7th Avenue South - Birmingham

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2011-01
Est. Completion 2013-12
Phase NA
Solventum US

41 total trials

What the finished NCT01369108 record still lists

NCT01369108 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 720-participant average among 30 other Dental Caries trials with a reported enrollment target (92% lower).

The record links to 1 condition, with Dental Caries appearing as the primary indexed condition, and to 2 interventions - of which Flowable composite is the first listed.

NCT01369108 reports a single indexed study location in Alabama.

Frequently Asked Questions

What is clinical trial NCT01369108 about?

NCT01369108 is a clinical study titled "Clinical Study on a New Flowable Composite as a Restorative in Adult Teeth". Study hypothesis: a new, low polymerization stress flowable composite performs no differently to a conventional, highly filled composite filling material when used as a restorative in small cavities in back teeth. Study will evaluate the clinical performance of a low shrinking flowable composite fi...

What is the current status of trial NCT01369108?

This trial is currently completed. It is a NA study. The enrollment target is 60 participants. The study started on 2011-01. Estimated completion is 2013-12.

What conditions does trial NCT01369108 study?

This clinical trial studies the following conditions: Dental Caries.

What interventions are being tested in trial NCT01369108?

The interventions under investigation include: Flowable composite (DEVICE), Conventional composite restorative (DEVICE).

Who is sponsoring clinical trial NCT01369108?

This trial is sponsored by Solventum US, which has 41 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01369108 being conducted?

This trial has 1 study location across Alabama. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Dental Caries

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT01369108's enrollment target sits among peer trials

60 14th of 30 higher than 17 of 30 other Dental Caries trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Dental Caries trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01369108, the US trial registry maintained by the National Library of Medicine. NCT01369108 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.