Trial Outcomes & Findings for Clinical Study on a New Flowable Composite as a Restorative in Adult Teeth (NCT NCT01369108)

Last Updated: 2024-10-02

Results Overview

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).

Recruitment status

COMPLETED

Study phase

Target enrollment

60 participants

Primary outcome timeframe

baseline, 6, 12 and 24 months

Results posted on

2024-10-02

Participant Flow

Participant milestones

Participant milestones
Measure	All Participants Each enrolled patient possessed two teeth that met the inclusion criteria. Of these, 120 teeth, 60 were allocated to the comparator group (Filtek Supreme Ultra Universal restorative) and 60 were allocated to the experimental group (Filtek Supreme Ultra Flowable. 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
Overall Study STARTED	60
Overall Study COMPLETED	49
Overall Study NOT COMPLETED	11

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=60 Participants Each enrolled patient possessed two teeth that met the inclusion criteria. Of these, 120 teeth, 60 were allocated to the comparator group (Filtek Supreme Ultra Universal restorative) and 60 were allocated to the experimental group (Filtek Supreme Ultra Flowable. 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
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	60 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	52 years n=5 Participants
Sex: Female, Male Female	43 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants
Region of Enrollment United States	60 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline, 6, 12 and 24 months

Outcome measures

Outcome measures
Measure	Flowable Composite n=49 teeth Flowable composite Flowable composite: Restoration of small Class V and I cavities in molar and premolar teeth	Conventional Composite n=49 teeth Highly filled conventional composite restorative Conventional composite restorative: Restoration of small Class V and I cavities in molar and premolar teeth
Clinical Performance by Cvar & Ryge Scores Marginal discoloration 12 Mo	90.9 percent of teeth	90.1 percent of teeth
Clinical Performance by Cvar & Ryge Scores Surface Integrity 12 Mo	92.7 percent of teeth	78.6 percent of teeth
Clinical Performance by Cvar & Ryge Scores Secondary caries 12 Mo	94.5 percent of teeth	94.6 percent of teeth
Clinical Performance by Cvar & Ryge Scores Anatomic form 24 Mo	89.8 percent of teeth	86.0 percent of teeth
Clinical Performance by Cvar & Ryge Scores Color match 24 Mo	85.7 percent of teeth	78.0 percent of teeth
Clinical Performance by Cvar & Ryge Scores Marginal adaption 24 Mo	83.7 percent of teeth	80.0 percent of teeth
Clinical Performance by Cvar & Ryge Scores Marginal discoloraton 24 Mo	85.7 percent of teeth	80.0 percent of teeth
Clinical Performance by Cvar & Ryge Scores Surface integrity 24 Mo	79.6 percent of teeth	78.0 percent of teeth
Clinical Performance by Cvar & Ryge Scores Secondary caries 24 Mo	93.9 percent of teeth	94 percent of teeth
Clinical Performance by Cvar & Ryge Scores Marginal discoloration 6 Mo	96.6 percent of teeth	95.0 percent of teeth
Clinical Performance by Cvar & Ryge Scores Color match baseline	96.6 percent of teeth	88.3 percent of teeth
Clinical Performance by Cvar & Ryge Scores Anatomic baseline	100.0 percent of teeth	100.0 percent of teeth
Clinical Performance by Cvar & Ryge Scores Marginal adaptation baseline	96.6 percent of teeth	98.3 percent of teeth
Clinical Performance by Cvar & Ryge Scores Marginal discoloration Baseline	98.3 percent of teeth	98.3 percent of teeth
Clinical Performance by Cvar & Ryge Scores Surface Integrity Baseline	98.3 percent of teeth	96.7 percent of teeth
Clinical Performance by Cvar & Ryge Scores Secondar carries Baseline	100. percent of teeth	98.3 percent of teeth
Clinical Performance by Cvar & Ryge Scores Anatomic form 6 Mo	100. percent of teeth	98.3 percent of teeth
Clinical Performance by Cvar & Ryge Scores Color match form 6 Mo	96.6 percent of teeth	91.7 percent of teeth
Clinical Performance by Cvar & Ryge Scores Marginal adaptation 6 Mo	93.2 percent of teeth	88.3 percent of teeth
Clinical Performance by Cvar & Ryge Scores Surface integrity 6 Mo	96.6 percent of teeth	90.0 percent of teeth
Clinical Performance by Cvar & Ryge Scores Secondary caries 6 Mo	100. percent of teeth	96.7 percent of teeth
Clinical Performance by Cvar & Ryge Scores Anatomic form 12 Mo	96.4 percent of teeth	94.6 percent of teeth
Clinical Performance by Cvar & Ryge Scores Color match 12 Mo	92.7 percent of teeth	83.9 percent of teeth
Clinical Performance by Cvar & Ryge Scores Marginal adaption 12 Mo	81.8 percent of teeth	78.6 percent of teeth

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Flowable Composite n=49 teeth Flowable composite Flowable composite: Restoration of small Class V and I cavities in molar and premolar teeth	Conventional Composite n=49 teeth Highly filled conventional composite restorative Conventional composite restorative: Restoration of small Class V and I cavities in molar and premolar teeth
Clinical Performance by VAS (Pain Scale) sensitiity to cold baseline	1.6 units on a scale Standard Deviation 1.6	1.6 units on a scale Standard Deviation 2.0
Clinical Performance by VAS (Pain Scale) sensitivity to biting baseline	0.5 units on a scale Standard Deviation 0.6	0.7 units on a scale Standard Deviation 0.7
Clinical Performance by VAS (Pain Scale) sensitiity to cold 6 Mo	1.5 units on a scale Standard Deviation 1.4	1.8 units on a scale Standard Deviation 1.7
Clinical Performance by VAS (Pain Scale) sensitiity to biting 6 Mo	0.6 units on a scale Standard Deviation 0.7	0.8 units on a scale Standard Deviation 0.8
Clinical Performance by VAS (Pain Scale) sensitiity to cold 12 Mo	2.1 units on a scale Standard Deviation 2.2	1.7 units on a scale Standard Deviation 1.7
Clinical Performance by VAS (Pain Scale) sensitiity to biting 12 Mo	0.3 units on a scale Standard Deviation 0.5	0.3 units on a scale Standard Deviation 0.5
Clinical Performance by VAS (Pain Scale) sensitiity to cold 24 Mo	1.5 units on a scale Standard Deviation 1.9	1.0 units on a scale Standard Deviation 1.3
Clinical Performance by VAS (Pain Scale) sensitiity to biting 24 Mo	0.2 units on a scale Standard Deviation 0.5	0.1 units on a scale Standard Deviation 0.3

Adverse Events

All Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Rolf Halvorson

3M Oral Care Solutions Division

Phone: 651-733-3384

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place