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

NCT01369108 | Completed Results

• 1 other identifier: CR-10-013
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dental Caries

Keywords

small Class I; molar and premolar; low stress flowable composite; adult; Restoration; small caries lesions

Outcome Measures

Primary Outcomes (2)

• 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).

  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.

  baseline, 6, 12 and 24 months

Study Arms (2)

Flowable composite

EXPERIMENTAL

Flowable composite

Device: Flowable composite

Conventional composite

ACTIVE COMPARATOR

Highly filled conventional composite restorative

Device: Conventional composite restorative

Interventions

Flowable composite DEVICE

Restoration of small Class V and I cavities in molar and premolar teeth

Also known as: Filtek Supreme Ultra Flowable Restorative 3M ESPE)

Flowable composite

Conventional composite restorative DEVICE

Restoration of small Class V and I cavities in molar and premolar teeth

Conventional composite

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Solventum US LLC: lead
• 3M: collaborator

Study Sites (1)

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

Birmingham, Alabama, 35233-2005, United States

Location

Related Publications (1)

• 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.

  PMID: 26237643 RESULT

MeSH Terms

Conditions

Dental Caries; Bicuspid Aortic Valve Disease

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases; Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Aortic Valve Disease; Heart Valve Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Results Point of Contact

• Title: Rolf Halvorson
• Organization: 3M Oral Care Solutions Division

rhhalvorson@mmm.com

651-733-3384

Study Officials

• John O Burgess, DDS, MS

  Unversity of Alabama at Birmingam Dental School

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2011
• First Posted: June 8, 2011
• Study Start: January 1, 2011
• Primary Completion: September 1, 2013
• Study Completion: December 1, 2013
• Last Updated: October 2, 2024
• Results First Posted: November 9, 2017

Record last verified: 2024-09

Locations

US (1)