Clinical Investigation of a New Bulk Fill Composite Resin in the Restoration of Posterior Teeth

Study Overview
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Brief Summary
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Polymerization shrinkage remains one of the primary disadvantages of composite resin restorative materials (tooth-colored fillings). To minimize the effects of polymerization shrinkage in the restorative treatment, the 3M ESPE company has developed a composite resin called Filtek Bulk Fill Posterior Restorative. Its decreased polymerization shrinkage and properties allow the material to be inserted in one single increment, expediting treatment. This clinical trial is designed to evaluate the performance of the new bulk fill composite resin in Class II (two-surface posterior) fillings.

Official Title
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Clinical Investigation of a New Bulk Fill Composite Resin in the Restoration of Posterior Teeth

Conditions
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Secondary Dental Caries Associated With Failed or Defective Dental Restorations, Fracture of Dental Restorative Materials With Loss of Material, Dental Restoration Failure of Marginal Integrity, Dental Caries, Unrepairable Overhanging of Dental Restorative Materials, Poor Aesthetics of Existing Restoration, Fractured Dental Restorative Materials Without Loss of Materials

Intervention / Treatment
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* Device: Filtek Bulk Fill Posterior
* Device: Filtek Supreme Ultra


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Posterior Composite Resin Restoration<br>Participants will receive two commercially available tooth-colored restorative materials used for direct restoration as per manufacturer's instructions. | Device: Filtek Bulk Fill Posterior<br>* 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.<br>* Other names: Dental filling;Device: Filtek Supreme Ultra<br>* 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.<br>* Other names: Dental filling;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Restoration Percent Success at Day 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] | Assessed immediately post restoration placement completion | 
| Restoration Percent Success at 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] | Year 1 | 
| Restoration Percent Success at 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] | Year 2 | 
| Restoration Percent Success at 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] | Year 3 | 
| Restoration Percent Success at 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] | Year 5 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adult dental care