Clinical Investigation of a New Bulk Fill Composite Resin in the Restoration of Posterior Teeth
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| ClinicalTrials.gov Identifier: NCT02572570 |
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Recruitment Status :
Terminated
(Attrition rate complicated by COVID-19 led to termination.)
First Posted : October 9, 2015
Results First Posted : December 19, 2020
Last Update Posted : December 19, 2020
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Dental Restoration Failure of Marginal Integrity Dental Caries Unrepairable Overhanging of Dental Restorative Materials Poor Aesthetics of Existing Restoration Secondary Dental Caries Associated With Failed or Defective Dental Restorations Fractured Dental Restorative Materials Without Loss of Materials Fracture of Dental Restorative Materials With Loss of Material | Device: Filtek Bulk Fill Posterior Device: Filtek Supreme Ultra | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 27 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Clinical Investigation of a New Bulk Fill Composite Resin in the Restoration of Posterior Teeth |
| Study Start Date : | December 2015 |
| Actual Primary Completion Date : | December 5, 2019 |
| Actual Study Completion Date : | December 5, 2019 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Posterior Composite Resin Restoration
Participants will receive two commercially available tooth-colored restorative materials used for direct restoration as per manufacturer's instructions.
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Device: Filtek Bulk Fill Posterior
Tooth (teeth) affected by dental caries or with an existing defective filling restored using the materials listed (Filtek Bulk Fill Posterior). Procedures done using local anesthesia and following ordinary restorative techniques.
Other Name: Dental filling Device: Filtek Supreme Ultra Tooth (teeth) affected by dental caries or with an existing defective filling restored using the materials listed (Filtek Supreme Ultra). Procedures done using local anesthesia and following ordinary restorative techniques.
Other Name: Dental filling |
- Restoration Percent Success at Day 1 [ Time Frame: Assessed immediately post restoration placement completion ]
The World Dental Federation (FDI) rates 16 categories on a scale of 1 to 5 with 1 being "Clinically Excellent" and 5 being "Clinically Poor". Scores 1-3 were considered clinically acceptable while scores 4 and 5 were considered failures. Cases were considered successful if each of the 16 following FDI criteria presented an individual score of 3 or less:
A.Esthetic Properties Surface lustre [Item 1] Surface staining [Item 2] Color stability and translucency [Item 3] Anatomic form [Item 4] B.Functional Properties Fractures and retention [Item 5] Marginal adaptation [Item 6] Wear [Item 7] Contact point/food impact [Item 8] Radiographic examination [Item 9] Patient's view [Item 10] C.Biological Properties Postoperative (hyper)sensitivity and tooth vitality [Item 11] Recurrence of caries, erosion, abfraction [Item 12] Tooth integrity [Item 13] Periodontal response [Item 14] Adjacent mucosa [Item 15] Oral and general health [Item 16]
- Restoration Percent Success at Year 1 [ Time Frame: Year 1 ]
The World Dental Federation (FDI) rates 16 categories on a scale of 1 to 5 with 1 being "Clinically Excellent" and 5 being "Clinically Poor". Scores 1-3 were considered clinically acceptable while scores 4 and 5 were considered failures. Cases were considered successful if each of the 16 following FDI criteria presented an individual score of 3 or less:
A.Esthetic Properties
- Surface lustre [Item 1]
- Surface staining [Item 2]
- Color stability and translucency [Item 3]
- Anatomic form [Item 4]
B.Functional Properties
- Fractures and retention [Item 5]
- Marginal adaptation [Item 6]
- Wear [Item 7]
- Contact point/food impact [Item 8]
- Radiographic examination [Item 9]
- Patient's view [Item 10]
C.Biological Properties
- Postoperative (hyper)sensitivity and tooth vitality [Item 11]
- Recurrence of caries, erosion, abfraction [Item 12]
- Tooth integrity [Item 13]
- Periodontal response [Item 14]
- Adjacent mucosa [Item 15]
- Oral and general health [Item 16]
- Restoration Percent Success at Year 2 [ Time Frame: Year 2 ]
The FDI rates 16 categories on a scale of 1 to 5 with 1 being "Clinically Excellent" and 5 being "Clinically Poor". Scores 1-3 were considered clinically acceptable while scores 4 and 5 were considered failures. Cases were considered successful if each of the 16 following FDI criteria presented an individual score of 3 or less:
A.Esthetic Properties
- Surface lustre [Item 1]
- Surface staining [Item 2]
- Color stability and translucency [Item 3]
- Anatomic form [Item 4]
B.Functional Properties
- Fractures and retention [Item 5]
- Marginal adaptation [Item 6]
- Wear [Item 7]
- Contact point/food impact [Item 8]
- Radiographic examination [Item 9]
- Patient's view [Item 10]
C.Biological Properties
- Postoperative (hyper)sensitivity and tooth vitality [Item 11]
- Recurrence of caries, erosion, abfraction [Item 12]
- Tooth integrity [Item 13]
- Periodontal response [Item 14]
- Adjacent mucosa [Item 15]
- Oral and general health [Item 16]
- Restoration Percent Success at Year 3 [ Time Frame: Year 3 ]
The FDI rates 16 categories on a scale of 1 to 5 with 1 being "Clinically Excellent" and 5 being "Clinically Poor". Scores 1-3 were considered clinically acceptable while scores 4 and 5 were considered failures. Cases were considered successful if each of the 16 following FDI criteria presented an individual score of 3 or less:
A.Esthetic Properties
- Surface lustre [Item 1]
- Surface staining [Item 2]
- Color stability and translucency [Item 3]
- Anatomic form [Item 4]
B.Functional Properties
- Fractures and retention [Item 5]
- Marginal adaptation [Item 6]
- Wear [Item 7]
- Contact point/food impact [Item 8]
- Radiographic examination [Item 9]
- Patient's view [Item 10]
C.Biological Properties
- Postoperative (hyper)sensitivity and tooth vitality [Item 11]
- Recurrence of caries, erosion, abfraction [Item 12]
- Tooth integrity [Item 13]
- Periodontal response [Item 14]
- Adjacent mucosa [Item 15]
- Oral and general health [Item 16]
- Restoration Percent Success at Year 5 [ Time Frame: Year 5 ]
The FDI rates 16 categories on a scale of 1 to 5 with 1 being "Clinically Excellent" and 5 being "Clinically Poor". Scores 1-3 were considered clinically acceptable while scores 4 and 5 were considered failures. Cases were considered successful if each of the 16 following FDI criteria presented an individual score of 3 or less:
A.Esthetic Properties
- Surface lustre [Item 1]
- Surface staining [Item 2]
- Color stability and translucency [Item 3]
- Anatomic form [Item 4]
B.Functional Properties
- Fractures and retention [Item 5]
- Marginal adaptation [Item 6]
- Wear [Item 7]
- Contact point/food impact [Item 8]
- Radiographic examination [Item 9]
- Patient's view [Item 10]
C.Biological Properties
- Postoperative (hyper)sensitivity and tooth vitality [Item 11]
- Recurrence of caries, erosion, abfraction [Item 12]
- Tooth integrity [Item 13]
- Periodontal response [Item 14]
- Adjacent mucosa [Item 15]
- Oral and general health [Item 16]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 99 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Be 18 years of age and older
- Have a pair of similar cavities or failed dental fillings in vital permanent posterior teeth requiring treatment
- Be capable of giving written informed consent.
Exclusion Criteria:
- Have a self-reported history of any adverse reaction to materials of the types to be evaluated
- Have a medical or dental history that could possibly complicate the provision of the proposed treatment and/or influence the behavior and performance of the treatment in clinical service.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02572570
| United States, North Carolina | |
| University of North Carolina at Chapel Hill School of Dentistry | |
| Chapel Hill, North Carolina, United States, 27599 | |
| Principal Investigator: | Rick Walter, DDS | University of North Carolina, Chapel Hill |
Documents provided by University of North Carolina, Chapel Hill:
| Responsible Party: | University of North Carolina, Chapel Hill |
| ClinicalTrials.gov Identifier: | NCT02572570 |
| Other Study ID Numbers: |
14-3097 |
| First Posted: | October 9, 2015 Key Record Dates |
| Results First Posted: | December 19, 2020 |
| Last Update Posted: | December 19, 2020 |
| Last Verified: | October 2020 |
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Adult dental care |
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Dental Caries Tooth Demineralization Tooth Diseases Stomatognathic Diseases |