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

Dental Caries Clinical Trial

Official title:

Clinical Evaluation of a Low Shrinkage Flowable Resin Composite in Adult Teeth

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01369108
• Other study ID #: CR-10-013
• Status: Completed
• Phase: N/A
• First received: June 7, 2011
• Last updated: November 7, 2017
• Start date: January 2011
• Est. completion date: December 2013

Study information

• Verified date: November 2017
• Source: 3M
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Dental Caries

Intervention

Device:
• Flowable composite
Restoration of small Class V and I cavities in molar and premolar teeth
• Conventional composite restorative
Restoration of small Class V and I cavities in molar and premolar teeth

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham School of Dentistry, 605 School of Dentistry Building, 1919 7th Avenue South	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
3M

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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