Prospective, Split-mouth, Comparative Study to Compare Cl... | NCT04708223

NCT04708223

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Fast-curing composites	Experimental		Device: Direct restorative treatment with fast-curing composites (Tetric PowerFill/ Tetric PowerFlow)
Conventionally applied composites	Other		Device: Direct restorative treatment with conventionally applied composites (Tetric EvoCeram Bulk Fill/ Tetric EvoFlow Bulk Fill)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Direct restorative treatment with fast-curing composites (Tetric PowerFill/ Tetric PowerFlow)	Device	Tooth (teeth) affected by dental caries or with an existing defective filling will be restored. Adhese Universal in self-etch mode, was used to prepare the surfaces for the composite fillings. Tetric PowerFill/ Tetric PowerFlow (test group) was cured for 3 s.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Teeth Analyzed According to FDI 11 - Postoperative Hypersensitivity	assessed by tests with thermal stimuli and occlusal forces (during biting) determined by VAS (Visual Analog Scale, 0 "No pain at all" - 10 "The worst pain imaginable") following the Fédération dentaire internationale (FDI) criteria on a scale from 1 "very good" to 5 "unacceptable"	Baseline
Number of Teeth Analyzed According to FDI 11 - Postoperative Hypersensitivity	assessed by tests with thermal stimuli and occlusal forces (during biting) determined by VAS (Visual Analog Scale, 0 "No pain at all" - 10 "The worst pain imaginable") following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable"	6 Month
Number of Teeth Analyzed According to FDI 11 - Postoperative Hypersensitivity	assessed by tests with thermal stimuli and occlusal forces (during biting) determined by VAS (Visual Analog Scale, 0 "No pain at all" - 10 "The worst pain imaginable") following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable"	12 Month
Number of Teeth Analyzed According to FDI 11 - Postoperative Hypersensitivity	assessed by tests with thermal stimuli and occlusal forces (during biting) determined by VAS (Visual Analog Scale, 0 "No pain at all" - 10 "The worst pain imaginable") following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable"	24 Month
Number of Teeth Analyzed According to FDI 11 - Postoperative Hypersensitivity	assessed by tests with thermal stimuli and occlusal forces (during biting) determined by VAS (Visual Analog Scale, 0 "No pain at all" - 10 "The worst pain imaginable") following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable"

Secondary Outcomes

Measure	Description	Time Frame
Restoration Quality Evaluation	assessed following the FDI criteria (patient view, tooth vitality, surface luster, surface staining, colour match, material fracture, marginal adaption, occlusal wear and tooth integrity) on a scale from 1 "very good" to 5 "unacceptable"	Baseline
Restoration Quality Evaluation

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Each subject must need at least 2 restorations in a vital posterior tooth (in different quadrants)
Restorations may be indicated for caries removal and restoration, replacement of defec-tive restorations (i.e. fractured, stained, unaesthetic), or requested replacement of un-aesthetic restorations.
Must have given written consent to participate in the trial
Must be available for the required follow-up visits over 2 years
Restored teeth must have occlusal contact with opposing teeth or restored teeth
Restoration width should be equal to or greater than 1/3 the distance from buccal to lin-gual cusp tips
75% of the restorations Class II (minimum) and 25% Class I
One, two or three surfaces per restoration
Each Class II will have at least one proximal contact
75% in molars (minimum) and 25% in premolars
All restored teeth must have at least one occlusal contact in habitual closure
Must have 20 or more teeth with evidence of bilateral posterior tooth contacts
Teeth that require one or no cuspal build-ups
Vital tooth
Preoperative sensibility on the teeth to be treated at maximum 3 on visual analog scale (10 = maximum)
Patient wishes to be treated in this clinical trial after oral information by the operator and after signing the informed patient form

Exclusion Criteria:

Allergies to ingredients of the materials under investigation (monomers)
Do not meet all inclusion criteria above
Have medical complications (organ transplants, long term antibiotic or steroid treatment, cancer or are immunocompromised) or disabilities rendering them unable to tolerate the time required to complete the restorations or to provide adequate oral hygiene
Suffer from xerostomia either by taking medications known to produce xerostomia or those with radiation induced xerostomia or Sjogren's syndrome subjects
Have teeth with advanced or severe periodontitis, rampant caries or poor oral hygiene which may require extraction of the teeth to be restored
Present with any systemic or local disorders that contraindicate the dental procedures included in this study
Patients reporting having severe grinding/bruxing or clenching or in need of TMJ-related therapy
Have tooth with exposed pulp during preparation or caries removal or require indirect pulp capping
Inclusion of teeth that are non-vital or that exhibit signs of pulpal pathology (pulpitis)
If the working field cannot be maintained in a dry state for treatment

Name	Affiliation	Role
Lyndon F. Cooper, Dr.	University of Illinois College of Dentistry	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
University of Illinois College of Dentistry		Chicago	Illinois	60612	United States

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Fast-curing composites	Direct restorative treatment with fast-curing composites (Tetric PowerFill/ Tetric PowerFlow): Tooth (teeth) affected by dental caries or with an existing defective filling will be restored. Adhese Universal in self-etch mode, was used to prepare the surfaces for the composite fillings. Tetric PowerFill/ Tetric PowerFlow (test group) was cured for 3 s.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Oct 16, 2018

Arm/Group Information

ID	Title	Description
BG000	Fast-curing composites	Direct restorative treatment with fast-curing composites (Tetric PowerFill/ Tetric PowerFlow): Tooth (teeth) affected by dental caries or with an existing defective filling will be restored. Adhese Universal in self-etch mode, was used to prepare the surfaces for the composite fillings. Tetric PowerFill/ Tetric PowerFlow (test group) was cured for 3 s.
BG001	Conventionally applied composites	Direct restorative treatment with conventionally applied composites (Tetric EvoCeram Bulk Fill/ Tetric EvoFlow Bulk Fill): Tooth (teeth) affected by dental caries or with an existing defective filling will be restored. Adhese Universal in self-etch mode, was used to prepare the surfaces for the composite fillings. Tetric EvoCeram Bulk Fill/ Tetric EvoFlow Bulk Fill (control group) were conventionally cured for 10 s per increment.
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG00051 BG00151 BG002153
Teeth	BG00050 BG00150 BG002100

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Customized

Number

participants

Participants

Units	Counts
Participants	BG00051 BG00151 BG00251
Teeth	BG000

Title

Denominators

Categories

FDI 11 - Postoperative Hypersensitivity: FDI Score 1

Title	Measurements
	OG00047 OG00145

FDI 11 - Postoperative Hypersensitivity: FDI Score 2

Title	Measurements
	OG000

Secondary

Restoration Quality Evaluation

assessed following the FDI criteria (patient view, tooth vitality, surface luster, surface staining, colour match, material fracture, marginal adaption, occlusal wear and tooth integrity) on a scale from 1 "very good" to 5 "unacceptable"

Posted

Number

Teeth

Baseline

Teeth

ID	Title	Description
OG000	Fast-curing composites	Direct restorative treatment with fast-curing composites (Tetric PowerFill/ Tetric PowerFlow): Tooth (teeth) affected by dental caries or with an existing defective filling will be restored. Adhese Universal in self-etch mode, was used to prepare the surfaces for the composite fillings. Tetric PowerFill/ Tetric PowerFlow (test group) was cured for 3 s.
OG001	Conventionally applied composites	Direct restorative treatment with conventionally applied composites (Tetric EvoCeram Bulk Fill/ Tetric EvoFlow Bulk Fill): Tooth (teeth) affected by dental caries or with an existing defective filling will be restored. Adhese Universal in self-etch mode, was used to prepare the surfaces for the composite fillings. Tetric EvoCeram Bulk Fill/ Tetric EvoFlow Bulk Fill (control group) were conventionally cured for 10 s per increment.

Units	Counts

Primary

Number of Teeth Analyzed According to FDI 11 - Postoperative Hypersensitivity

assessed by tests with thermal stimuli and occlusal forces (during biting) determined by VAS (Visual Analog Scale, 0 "No pain at all" - 10 "The worst pain imaginable") following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable"

Posted

Number

Teeth

6 Month

Teeth

ID	Title	Description
OG000	Fast-curing composites	Direct restorative treatment with fast-curing composites (Tetric PowerFill/ Tetric PowerFlow): Tooth (teeth) affected by dental caries or with an existing defective filling will be restored. Adhese Universal in self-etch mode, was used to prepare the surfaces for the composite fillings. Tetric PowerFill/ Tetric PowerFlow (test group) was cured for 3 s.
OG001	Conventionally applied composites	Direct restorative treatment with conventionally applied composites (Tetric EvoCeram Bulk Fill/ Tetric EvoFlow Bulk Fill): Tooth (teeth) affected by dental caries or with an existing defective filling will be restored. Adhese Universal in self-etch mode, was used to prepare the surfaces for the composite fillings. Tetric EvoCeram Bulk Fill/ Tetric EvoFlow Bulk Fill (control group) were conventionally cured for 10 s per increment.

Units

Primary

Number of Teeth Analyzed According to FDI 11 - Postoperative Hypersensitivity

assessed by tests with thermal stimuli and occlusal forces (during biting) determined by VAS (Visual Analog Scale, 0 "No pain at all" - 10 "The worst pain imaginable") following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable"

Posted

Number

Teeth

12 Month

Teeth

ID	Title	Description
OG000	Fast-curing composites	Direct restorative treatment with fast-curing composites (Tetric PowerFill/ Tetric PowerFlow): Tooth (teeth) affected by dental caries or with an existing defective filling will be restored. Adhese Universal in self-etch mode, was used to prepare the surfaces for the composite fillings. Tetric PowerFill/ Tetric PowerFlow (test group) was cured for 3 s.
OG001	Conventionally applied composites	Direct restorative treatment with conventionally applied composites (Tetric EvoCeram Bulk Fill/ Tetric EvoFlow Bulk Fill): Tooth (teeth) affected by dental caries or with an existing defective filling will be restored. Adhese Universal in self-etch mode, was used to prepare the surfaces for the composite fillings. Tetric EvoCeram Bulk Fill/ Tetric EvoFlow Bulk Fill (control group) were conventionally cured for 10 s per increment.

Units

Primary

Number of Teeth Analyzed According to FDI 11 - Postoperative Hypersensitivity

assessed by tests with thermal stimuli and occlusal forces (during biting) determined by VAS (Visual Analog Scale, 0 "No pain at all" - 10 "The worst pain imaginable") following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable"

Posted

Number

Teeth

24 Month

Teeth

ID	Title	Description
OG000	Fast-curing composites	Direct restorative treatment with fast-curing composites (Tetric PowerFill/ Tetric PowerFlow): Tooth (teeth) affected by dental caries or with an existing defective filling will be restored. Adhese Universal in self-etch mode, was used to prepare the surfaces for the composite fillings. Tetric PowerFill/ Tetric PowerFlow (test group) was cured for 3 s.
OG001	Conventionally applied composites	Direct restorative treatment with conventionally applied composites (Tetric EvoCeram Bulk Fill/ Tetric EvoFlow Bulk Fill): Tooth (teeth) affected by dental caries or with an existing defective filling will be restored. Adhese Universal in self-etch mode, was used to prepare the surfaces for the composite fillings. Tetric EvoCeram Bulk Fill/ Tetric EvoFlow Bulk Fill (control group) were conventionally cured for 10 s per increment.

Units

Primary

Number of Teeth Analyzed According to FDI 11 - Postoperative Hypersensitivity

assessed by tests with thermal stimuli and occlusal forces (during biting) determined by VAS (Visual Analog Scale, 0 "No pain at all" - 10 "The worst pain imaginable") following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable"

Posted

Number

Teeth

36 Month

Teeth

ID	Title	Description
OG000	Fast-curing composites	Direct restorative treatment with fast-curing composites (Tetric PowerFill/ Tetric PowerFlow): Tooth (teeth) affected by dental caries or with an existing defective filling will be restored. Adhese Universal in self-etch mode, was used to prepare the surfaces for the composite fillings. Tetric PowerFill/ Tetric PowerFlow (test group) was cured for 3 s.
OG001	Conventionally applied composites	Direct restorative treatment with conventionally applied composites (Tetric EvoCeram Bulk Fill/ Tetric EvoFlow Bulk Fill): Tooth (teeth) affected by dental caries or with an existing defective filling will be restored. Adhese Universal in self-etch mode, was used to prepare the surfaces for the composite fillings. Tetric EvoCeram Bulk Fill/ Tetric EvoFlow Bulk Fill (control group) were conventionally cured for 10 s per increment.

Units

Secondary

Restoration Quality Evaluation

Posted

Number

Teeth

6 Month

Teeth

ID	Title	Description
OG000	Fast-curing composites	Direct restorative treatment with fast-curing composites (Tetric PowerFill/ Tetric PowerFlow): Tooth (teeth) affected by dental caries or with an existing defective filling will be restored. Adhese Universal in self-etch mode, was used to prepare the surfaces for the composite fillings. Tetric PowerFill/ Tetric PowerFlow (test group) was cured for 3 s.
OG001	Conventionally applied composites	Direct restorative treatment with conventionally applied composites (Tetric EvoCeram Bulk Fill/ Tetric EvoFlow Bulk Fill): Tooth (teeth) affected by dental caries or with an existing defective filling will be restored. Adhese Universal in self-etch mode, was used to prepare the surfaces for the composite fillings. Tetric EvoCeram Bulk Fill/ Tetric EvoFlow Bulk Fill (control group) were conventionally cured for 10 s per increment.

Units	Counts

Secondary

Restoration Quality Evaluation

Posted

Number

Teeth

12 Month

Teeth

ID	Title	Description
OG000	Fast-curing composites	Direct restorative treatment with fast-curing composites (Tetric PowerFill/ Tetric PowerFlow): Tooth (teeth) affected by dental caries or with an existing defective filling will be restored. Adhese Universal in self-etch mode, was used to prepare the surfaces for the composite fillings. Tetric PowerFill/ Tetric PowerFlow (test group) was cured for 3 s.
OG001	Conventionally applied composites	Direct restorative treatment with conventionally applied composites (Tetric EvoCeram Bulk Fill/ Tetric EvoFlow Bulk Fill): Tooth (teeth) affected by dental caries or with an existing defective filling will be restored. Adhese Universal in self-etch mode, was used to prepare the surfaces for the composite fillings. Tetric EvoCeram Bulk Fill/ Tetric EvoFlow Bulk Fill (control group) were conventionally cured for 10 s per increment.

Units	Counts

Secondary

Restoration Quality Evaluation

Posted

Number

Teeth

24 Month

Teeth

ID	Title	Description
OG000	Fast-curing composites	Direct restorative treatment with fast-curing composites (Tetric PowerFill/ Tetric PowerFlow): Tooth (teeth) affected by dental caries or with an existing defective filling will be restored. Adhese Universal in self-etch mode, was used to prepare the surfaces for the composite fillings. Tetric PowerFill/ Tetric PowerFlow (test group) was cured for 3 s.
OG001	Conventionally applied composites	Direct restorative treatment with conventionally applied composites (Tetric EvoCeram Bulk Fill/ Tetric EvoFlow Bulk Fill): Tooth (teeth) affected by dental caries or with an existing defective filling will be restored. Adhese Universal in self-etch mode, was used to prepare the surfaces for the composite fillings. Tetric EvoCeram Bulk Fill/ Tetric EvoFlow Bulk Fill (control group) were conventionally cured for 10 s per increment.

Units	Counts

Secondary

Restoration Quality Evaluation

Posted

Number

Teeth

36 Month

Teeth

ID	Title	Description
OG000	Fast-curing composites	Direct restorative treatment with fast-curing composites (Tetric PowerFill/ Tetric PowerFlow): Tooth (teeth) affected by dental caries or with an existing defective filling will be restored. Adhese Universal in self-etch mode, was used to prepare the surfaces for the composite fillings. Tetric PowerFill/ Tetric PowerFlow (test group) was cured for 3 s.
OG001	Conventionally applied composites	Direct restorative treatment with conventionally applied composites (Tetric EvoCeram Bulk Fill/ Tetric EvoFlow Bulk Fill): Tooth (teeth) affected by dental caries or with an existing defective filling will be restored. Adhese Universal in self-etch mode, was used to prepare the surfaces for the composite fillings. Tetric EvoCeram Bulk Fill/ Tetric EvoFlow Bulk Fill (control group) were conventionally cured for 10 s per increment.

Units	Counts

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Fast-curing composites	Direct restorative treatment with fast-curing composites (Tetric PowerFill/ Tetric PowerFlow): Tooth (teeth) affected by dental caries or with an existing defective filling will be restored. Adhese Universal in self-etch mode, was used to prepare the surfaces for the composite fillings. Tetric PowerFill/ Tetric PowerFlow (test group) was cured for 3 s.	0	51	0	51	5	51
EG001	Conventionally applied composites	Direct restorative treatment with conventionally applied composites (Tetric EvoCeram Bulk Fill/ Tetric EvoFlow Bulk Fill): Tooth (teeth) affected by dental caries or with an existing defective filling will be restored. Adhese Universal in self-etch mode, was used to prepare the surfaces for the composite fillings. Tetric EvoCeram Bulk Fill/ Tetric EvoFlow Bulk Fill (control group) were conventionally cured for 10 s per increment.	0	51	0	51	3	51

Other Adverse Events

Term	Organ System	Assessment Type	Notes	Statistical Information
Unrelated: Lesion next to study tooth	General disorders	Systematic Assessment	Patient showed sensitivity on study tooth due to a lesion on the tooth next to the study tooth	EG0001 affected51 at risk EG0010 affected51 at risk
Buccal side repair	General disorders	Systematic Assessment	Buccal side repair due to material fracture	EG0000 affected51 at risk EG0011 affected51 at risk
Unlikely related: Sensitivity near study tooth	General disorders	Systematic Assessment		EG0001 affected51 at risk EG0010 affected51 at risk
Sensitivity	General disorders	Systematic Assessment	It is generally related to this type of clinical procedure and might also be dependent on the applied light intensity, the used adhesive or the backstory of the tooth	EG0003 affected51 at risk EG0012 affected51 at risk