Clinical Evaluation of a Bulk Fill Resin Composite

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04686422

Enrollment

Registered

2020-12-28

Start date

2017-12-01

Completion date

2021-06-30

Last updated

2025-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Caries, Unsatisfactory or Defective Restoration of Tooth

Brief summary

The purpose of this clinical trial is to measure the clinical outcomes of Tetric PowerFill Class I and II restorations cured in 3 seconds with the Bluephase PowerCure curing unit.

Interventions

DEVICETetric PowerFill

Tooth (teeth) affected by dental caries or with an existing defective filling will be restored using the PowerCure system.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to 90 Years

Healthy volunteers

Inclusion criteria

* Each subject must need at least 1 restoration in a vital posterior tooth * Must have given written consent to participate in the trial * Replacement of defective restorations (i.e. fractured, stained, unaesthetic) with or with-out caries are acceptable * Must be available for the required follow-up visits over 3 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 * 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

Exclusion criteria

* If they have an allergy to ingredients of the materials under investigation (monomers) * Do not meet all inclusion criteria above * Have severe medical complications (organ transplants, long term antibiotic or steroid treatment, cancer or are immunocompromised) or disabilities meaning they may not be able to tolerate the time required to complete the restorations or to provide adequate oral hygiene * Have xerostomia either by taking medications known to produce xerostomia or those with radiation-induced xerostomia or Sjogren's syndrome - as dry mouth increases tooth and restoration wear as well as the development of caries. * 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 * Have unstable occlusion * Have severe grinding/bruxing or clenching or need TMJ-related therapy * Have tooth with exposed pulp during preparation or caries removal * Teeth that are non-vital or that exhibit signs of pulpal pathology for restoration * Teeth that require cuspal build-ups involving more than one cusp

Design outcomes

Primary

Measure	Time frame	Description
FDI 11 - Postoperative Hypersensitivity	Baseline	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
Pulp Integrity	Baseline	Restored teeth are assessed by a cold air stimuli test (air syringe) by VAS (Visual Analog Scale, 0 No pain at all - 10 The worst pain imaginable)
Overall Survival Rate	Baseline	Restorations were examined by a dentist

Secondary

Measure	Time frame	Description
FDI Criteria (Surface Lustre, Surface Staining, Colour Match, Material Fracture, Occlusal Wear, Tooth Integrity)	Baseline	assessed following the FDI criteria on a scale from 1 very good to 5 unacceptable

Countries

United States

Participant flow

Participants by arm

Arm	Count
Tetric PowerFill Class I and II restorations Tetric PowerFill: Tooth (teeth) affected by dental caries or with an existing defective filling will be restored using the PowerCure system.	39
Tetric PowerFill Class I and II restorations Tetric PowerFill: Tooth (teeth) affected by dental caries or with an existing defective filling will be restored using the PowerCure system.	68
Total	107

Baseline characteristics

Characteristic	Tetric PowerFill Class I and II restorations
Age, Customized <= 18 years	0 Participants
Age, Customized Between 18 and 90 years	39 Participants
Sex: Female, Male Female	29 Participants
Sex: Female, Male Male	10 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 39
other Total, other adverse events	2 / 39
serious Total, serious adverse events	0 / 39

Outcome results

Primary

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

Time frame: Baseline

Arm	Measure	Group	Value (NUMBER)
Tetric PowerFill Class I and II restorations	FDI 11 - Postoperative Hypersensitivity	FDI Score 1	55 Restorations
Tetric PowerFill Class I and II restorations	FDI 11 - Postoperative Hypersensitivity	FDI Score 2	10 Restorations
Tetric PowerFill Class I and II restorations	FDI 11 - Postoperative Hypersensitivity	FDI Score 3	3 Restorations
Tetric PowerFill Class I and II restorations	FDI 11 - Postoperative Hypersensitivity	FDI Score 4-5	0 Restorations

Primary

FDI 11 - Postoperative Hypersensitivity

Time frame: 36 Month

Arm	Measure	Group	Value (NUMBER)
Tetric PowerFill Class I and II restorations	FDI 11 - Postoperative Hypersensitivity	FDI Score 1	40 Restorations
Tetric PowerFill Class I and II restorations	FDI 11 - Postoperative Hypersensitivity	FDI Score 2	0 Restorations
Tetric PowerFill Class I and II restorations	FDI 11 - Postoperative Hypersensitivity	FDI Score 3	0 Restorations
Tetric PowerFill Class I and II restorations	FDI 11 - Postoperative Hypersensitivity	FDI Score 4-5	0 Restorations

Primary

FDI 11 - Postoperative Hypersensitivity

Time frame: 12 Month

Arm	Measure	Group	Value (NUMBER)
Tetric PowerFill Class I and II restorations	FDI 11 - Postoperative Hypersensitivity	FDI Score 1	59 Restorations
Tetric PowerFill Class I and II restorations	FDI 11 - Postoperative Hypersensitivity	FDI Score 2	2 Restorations
Tetric PowerFill Class I and II restorations	FDI 11 - Postoperative Hypersensitivity	FDI Score 3	1 Restorations
Tetric PowerFill Class I and II restorations	FDI 11 - Postoperative Hypersensitivity	FDI Score 4-5	0 Restorations

Primary

FDI 11 - Postoperative Hypersensitivity

Time frame: 6 Month

Arm	Measure	Group	Value (NUMBER)
Tetric PowerFill Class I and II restorations	FDI 11 - Postoperative Hypersensitivity	FDI Score 1	60 Restorations
Tetric PowerFill Class I and II restorations	FDI 11 - Postoperative Hypersensitivity	FDI Score 2	3 Restorations
Tetric PowerFill Class I and II restorations	FDI 11 - Postoperative Hypersensitivity	FDI Score 3	3 Restorations
Tetric PowerFill Class I and II restorations	FDI 11 - Postoperative Hypersensitivity	FDI Score 4-5	0 Restorations

Primary

FDI 11 - Postoperative Hypersensitivity

Time frame: 24 Month

Arm	Measure	Group	Value (NUMBER)
Tetric PowerFill Class I and II restorations	FDI 11 - Postoperative Hypersensitivity	FDI Score 1	50 Restorations
Tetric PowerFill Class I and II restorations	FDI 11 - Postoperative Hypersensitivity	FDI Score 2	2 Restorations
Tetric PowerFill Class I and II restorations	FDI 11 - Postoperative Hypersensitivity	FDI Score 3	0 Restorations
Tetric PowerFill Class I and II restorations	FDI 11 - Postoperative Hypersensitivity	FDI Score 4-5	0 Restorations

Primary

Overall Survival Rate

Restorations were examined by a dentist

Time frame: 6 Month

Arm	Measure	Value (NUMBER)
Tetric PowerFill Class I and II restorations	Overall Survival Rate	66 Restorations

Primary

Overall Survival Rate

Restorations were examined by a dentist

Time frame: 24 Month

Arm	Measure	Group	Value (NUMBER)
Tetric PowerFill Class I and II restorations	Overall Survival Rate	Survived	51 Restorations
Tetric PowerFill Class I and II restorations	Overall Survival Rate	Failed	1 Restorations

Primary

Overall Survival Rate

Restorations were examined by a dentist

Time frame: 12 Month

Arm	Measure	Value (NUMBER)
Tetric PowerFill Class I and II restorations	Overall Survival Rate	62 Restorations

Primary

Overall Survival Rate

Restorations were examined by a dentist

Time frame: Baseline

Arm	Measure	Value (NUMBER)
Tetric PowerFill Class I and II restorations	Overall Survival Rate	68 Restorations

Primary

Overall Survival Rate

Restorations were examined by a dentist

Time frame: 36 Month

Arm	Measure	Group	Value (NUMBER)
Tetric PowerFill Class I and II restorations	Overall Survival Rate	Survived	38 Restorations
Tetric PowerFill Class I and II restorations	Overall Survival Rate	Failed	2 Restorations

Primary