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

Dental Caries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02572570
• Other study ID #: 14-3097
• Status: Terminated
• Phase: N/A
• Start date: December 2015
• Est. completion date: December 5, 2019

Study information

• Verified date: October 2020
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 27
• Est. completion date: December 5, 2019
• Est. primary completion date: December 5, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of North Carolina at Chapel Hill School of Dentistry	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	3M ESPE

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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