Dental CariesNCT01369108

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

A study testing Flowable composite and Conventional composite restorative in people with Dental Caries, run by Solventum US LLC at 1 site in United States.

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

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. Read more about this study

Who is it for?: Ages 19 years and older
Conditions the study is for: Dental Caries
What is being tested?: Flowable composite and Conventional composite restorative
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteUnited States
Study dates: Jan 2011to Dec 2013
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 19 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

19 years or older
must give written consent
be in good general health
be available for required follow-up visits
have at least 28 teeth

Who cannot join

has rampant, uncontrolled caries
has advanced, untreated periodontal disease
heavy use of smoking tobacco (2 packs or equivalent a day)or chewing tobacco
has systemic or local disorders that contra-indicate the dental procedures needed in this study
has evidence of xerostomia
has evidence of severe bruxing or clenching, or in need of Temporomandibular Joint (TMJ) related therapy
is pregnant at time of screening or tooth restoration
has known sensitivity to acrylates or related materials

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Alabama at Birmingham School of Dentistry, 605 School of Dentistry Building, 1919 7th Avenue South
Birmingham, Alabama, 35233-2005

Other trials in United States

About this study

Official title: Clinical Evaluation of a Low Shrinkage Flowable Resin Composite in Adult 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.

Read the detailed description

The study will evaluate clinical performance of a low shrink flowable composite filling material and compare it with a conventional, highly filled composite. The study materials will be used to restore small cavities in molar and premolar teeth in adult patients.

Conditions: Dental Caries
Being tested: Flowable composite, Conventional composite restorative
Keywords: small Class I, molar and premolar, low stress flowable composite, adult, Restoration, small caries lesions
Medical subject headings: Dental Caries, Bicuspid Aortic Valve Disease

What participants receive

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

Flowable compositeDevice
Also called Filtek Supreme Ultra Flowable Restorative 3M ESPE)
Restoration of small Class V and I cavities in molar and premolar teeth
Conventional composite restorativeDevice
Restoration of small Class V and I cavities in molar and premolar teeth

Study groups in NCT01369108
Study group	Role	What they receive
Flowable composite	Experimental	Flowable composite Receives: Device: Flowable composite
Conventional composite	Active comparator	Highly filled conventional composite restorative Receives: Device: Conventional composite restorative

What is being measured

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

Clinical Performance by Cvar & Ryge Scores
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 pulpal direction); Surface Integrity (A=smooth, B=slight rough, C=Pitted, D=fracture)'Secondary caries (A=none, D=present).
Measured: baseline, 6, 12 and 24 months
Clinical Performance by VAS (Pain Scale)
Sensitivity to cold was measured by applying a cotton pellet soaked with pulp vitality refrigerant spray (Endo Ice, Coltene/ Whaledent, Cuyahoga Falls, OH, USA) to the tooth for three seconds. Sensitivity to biting was measured by having the patient bite on a cotton roll for five seconds. After each test, the subject was asked to place an ''X'' on a 10-mm line labeled ''1'' on the left and ''10'' on the right. Patients were told that a ''10'' represents the worst pain they can imagine (ie, childbirth, major surgery, or kidney stone) and that ''1'' represents no sensation at all.
Measured: baseline, 6, 12 and 24 months

Timeline

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

Jan 2011Dec 2013

First posted8 Jun 2011 (estimated)
Study startJan 2011
Primary completionSep 2013
Study completionDec 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Dental CariesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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
Masking: Single blind
Who is masked: Participant
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01369108
Sponsor's protocol ID: CR-10-013
Status last verified: Sep 2024
First submitted: 7 Jun 2011
Last updated: 2 Oct 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Lawson NC, Radhakrishnan R, Givan DA, Ramp LC, Burgess JO. Two-year Randomized, Controlled Clinical Trial of a Flowable and Conventional Composite in Class I Restorations. Oper Dent. 2015 Nov-Dec;40(6):594-602. doi: 10.2341/15-038-C. Epub 2015 Aug 3.
PubMed 26237643

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Evaluation of a Low Shrinkage Flowable Resin Composite in Adult Teeth
ClinicalTrials.gov ID: NCT01369108
Acronym / sponsor ID: CR-10-013
Conditions: Dental Caries
Keywords: small Class I, molar and premolar, low stress flowable composite, adult, Restoration, small caries lesions
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Solventum US LLCIndustry (pharma, biotech, devices)
Collaborators: 3M
Study start: Jan 2011
Primary completion: Sep 2013 (actual)
Study completion: Dec 2013 (actual)
First posted: 8 Jun 2011 (estimated)
Results: Posted 9 Nov 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Flowable composite	Experimental	Device: Flowable compositeFlowable composite
Conventional composite	Active comparator	Device: Conventional composite restorativeHighly filled conventional composite restorative

Who may qualify

Ages: 19 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

19 years or older
must give written consent
be in good general health
be available for required follow-up visits
have at least 28 teeth

Key exclusion criteria (8 listed)

has rampant, uncontrolled caries
has advanced, untreated periodontal disease
heavy use of smoking tobacco (2 packs or equivalent a day)or chewing tobacco
has systemic or local disorders that contra-indicate the dental procedures needed in this study
has evidence of xerostomia

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Flowable compositeAlso: Filtek Supreme Ultra Flowable Restorative 3M ESPE)Restoration of small Class V and I cavities in molar and premolar teeth	Device	Flowable composite
Conventional composite restorativeRestoration of small Class V and I cavities in molar and premolar teeth	Device	Conventional composite

Primary outcome

Clinical Performance by Cvar & Ryge Scores
Time frame: baseline, 6, 12 and 24 months
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 pulpal direction); Surface Integrity (A=smooth, B=slight rough, C=Pitted, D=fracture)'Secondary caries (A=none, D=present).
Clinical Performance by VAS (Pain Scale)
Time frame: baseline, 6, 12 and 24 months
Sensitivity to cold was measured by applying a cotton pellet soaked with pulp vitality refrigerant spray (Endo Ice, Coltene/ Whaledent, Cuyahoga Falls, OH, USA) to the tooth for three seconds. Sensitivity to biting was measured by having the patient bite on a cotton roll for five seconds. After each test, the subject was asked to place an ''X'' on a 10-mm line labeled ''1'' on the left and ''10'' on the right. Patients were told that a ''10'' represents the worst pain they can imagine (ie, childbirth, major surgery, or kidney stone) and that ''1'' represents no sensation at all.

Results and safety

Results posted to the registry on 9 Nov 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Participants	60	49

Primary outcome: Clinical Performance by Cvar & Ryge Scores

Time frame: baseline, 6, 12 and 24 months. Number. Unit: percent of teeth

Measure	Flowable Composite n = 49	Conventional Composite n = 49
Color match baseline	96.6	88.3
Anatomic baseline	100.0	100.0
Marginal adaptation baseline	96.6	98.3
Marginal discoloration Baseline	98.3	98.3
Surface Integrity Baseline	98.3	96.7
Secondar carries Baseline	100.	98.3
Anatomic form 6 Mo	100.	98.3
Color match form 6 Mo	96.6	91.7

Flowable Composite vs Conventional Composite: p = 0.8, ANOVA
Flowable Composite vs Conventional Composite: p = 0.89, ANOVA
Flowable Composite vs Conventional Composite: p = 0.79, ANOVA

Primary outcome: Clinical Performance by VAS (Pain Scale)

Time frame: baseline, 6, 12 and 24 months. Mean (Standard Deviation). Unit: units on a scale

Measure	Flowable Composite n = 49	Conventional Composite n = 49
sensitiity to cold baseline	1.6 (1.6)	1.6 (2.0)
sensitivity to biting baseline	0.5 (0.6)	0.7 (0.7)
sensitiity to cold 6 Mo	1.5 (1.4)	1.8 (1.7)
sensitiity to biting 6 Mo	0.6 (0.7)	0.8 (0.8)
sensitiity to cold 12 Mo	2.1 (2.2)	1.7 (1.7)
sensitiity to biting 12 Mo	0.3 (0.5)	0.3 (0.5)
sensitiity to cold 24 Mo	1.5 (1.9)	1.0 (1.3)
sensitiity to biting 24 Mo	0.2 (0.5)	0.1 (0.3)

Flowable Composite vs Conventional Composite: p = 0.522, ANOVA
Flowable Composite vs Conventional Composite: p = .449, Chi-squared

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All Participants	0 of 60 (0%)	0 of 60 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 26237643Lawson NC, Radhakrishnan R, Givan DA, Ramp LC, Burgess JO. Two-year Randomized, Controlled Clinical Trial of a Flowable and Conventional Composite in Class I Restorations. Oper Dent. 2015 Nov-Dec;40(6):594-602. doi: 10.2341/15-038-C. Epub 2015 Aug 3.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

John O Burgess, DDS, MS principal investigator

Unversity of Alabama at Birmingam Dental School

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Flowable composite and Conventional composite restorative in people with Dental Caries, run by Solventum US LLC at 1 site in United States.

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 5 inclusion and 8 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 2 Oct 2024. 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 United States. 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?

Yes. Results are posted in the registry (first posted 9 Nov 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Clinical Performance by Cvar & Ryge Scores (time frame: baseline, 6, 12 and 24 months). The study lists 2 primary outcomes in all. 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 NCT01369108, which also lists 1 linked publication.

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 2 Oct 2024.