Clinical Performance of Incremental and Bulk Fill Composites in Class II Restorations
Study Details
Study Description
Brief Summary
This study will examine the clinical performance of Class II restorations over a three year period with 3 composite resins - a conventional composite resin, a flowable composite resin and a bulk placed and cured composite resin.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Specific Aim: To place three commercially available resin composites in Class II cavity preparations of adult patients, evaluate the resin composite restorations at baseline, 6 months, 1 year, 2 and 3 years using specific criteria (direct and indirect).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Universal Composite Supreme Universal Restorative |
Device: Supreme Universal Restorative
|
| Experimental: Flowable Composite Supreme Flowable Restorative |
Device: Supreme Flowable Restorative
|
| Experimental: Bulk Fill Flowable Composite Bulk Fill Flowable Restorative |
Device: Bulk Fill Flowable Restorative
|
Outcome Measures
Primary Outcome Measures
- Percent Acceptable Restorations [3 years]
Secondary Outcome Measures
- Anatomic Form [6 Months]
A = The restoration is continuous with existing form. B = The restoration is discontinuous with existing anatomic form, but the existing material is not sufficient to expose dentine. C = Sufficient material lost to expose dentine or lining material.
- Anatomic Form [1 Year]
A = The restoration is continuous with existing form. B = The restoration is discontinuous with existing anatomic form, but the existing material is not sufficient to expose dentine. C = Sufficient material lost to expose dentine or lining material.
- Anatomic Form [2 Year]
A = The restoration is continuous with existing form. B = The restoration is discontinuous with existing anatomic form, but the existing material is not sufficient to expose dentine. C = Sufficient material lost to expose dentine or lining material.
- Anatomic Form [3 Year]
A = The restoration is continuous with existing form. B = The restoration is discontinuous with existing anatomic form, but the existing material is not sufficient to expose dentine. C = Sufficient material lost to expose dentine or lining material.
- Color Match [6 Month]
A = The restoration appears to match the shade and translucency of adjacent tooth structure. B = The restoration does not match the shade and translucency of adjacent tooth structure, but the mismatch is within the normal range of tooth shades and translucency. C = The restoration does not match the shade and translucency of the adjacent tooth structure, and the mismatch is outside the normal range of tooth shades and translucency.
- Color Match [1 Year]
A = The restoration appears to match the shade and translucency of adjacent tooth structure. B = The restoration does not match the shade and translucency of adjacent tooth structure, but the mismatch is within the normal range of tooth shades and translucency. C = The restoration does not match the shade and translucency of the adjacent tooth structure, and the mismatch is outside the normal range of tooth shades and translucency.
- Color Match [2 Year]
A = The restoration appears to match the shade and translucency of adjacent tooth structure. B = The restoration does not match the shade and translucency of adjacent tooth structure, but the mismatch is within the normal range of tooth shades and translucency. C = The restoration does not match the shade and translucency of the adjacent tooth structure, and the mismatch is outside the normal range of tooth shades and translucency.
- Color Match [3 Year]
A = The restoration appears to match the shade and translucency of adjacent tooth structure. B = The restoration does not match the shade and translucency of adjacent tooth structure, but the mismatch is within the normal range of tooth shades and translucency. C = The restoration does not match the shade and translucency of the adjacent tooth structure, and the mismatch is outside the normal range of tooth shades and translucency.
- Margin Adaptation [6 Month]
A = No visible evidence of a crevice along the margin into which the explorer will penetrate. B = Visible evidence of a crevice, and dentin or base is exposed. C = Explorer penetrates into crevice, and dentin or base is exposed. D = Restoration is mobile, fractured or missing.
- Margin Adaptation [1 Year]
A = No visible evidence of a crevice along the margin into which the explorer will penetrate. B = Visible evidence of a crevice, and dentin or base is exposed. C = Explorer penetrates into crevice, and dentin or base is exposed. D = Restoration is mobile, fractured or missing.
- Margin Adaptation [2 Year]
A = No visible evidence of a crevice along the margin into which the explorer will penetrate. B = Visible evidence of a crevice, and dentin or base is exposed. C = Explorer penetrates into crevice, and dentin or base is exposed. D = Restoration is mobile, fractured or missing.
- Margin Adaptation [3 Year]
A = No visible evidence of a crevice along the margin into which the explorer will penetrate. B = Visible evidence of a crevice, and dentin or base is exposed. C = Explorer penetrates into crevice, and dentin or base is exposed. D = Restoration is mobile, fractured or missing.
- Margin Discoloration [6 Month]
A = There is no visual evidence of marginal discoloration different from the color of the restorative material and from the color the adjacent tooth structure. B = There is visual evidence of marginal discoloration at the junction of the tooth structure and the restoration, but the discoloration has not penetrated along the restoration in a pulpal direction. C = There is visual evidence of marginal discoloration at the junction of the tooth structure and the restoration that has penetrated along the restoration in a pulpal direction.
- Margin Discoloration [1 Year]
A = There is no visual evidence of marginal discoloration different from the color of the restorative material and from the color the adjacent tooth structure. B = There is visual evidence of marginal discoloration at the junction of the tooth structure and the restoration, but the discoloration has not penetrated along the restoration in a pulpal direction. C = There is visual evidence of marginal discoloration at the junction of the tooth structure and the restoration that has penetrated along the restoration in a pulpal direction.
- Margin Discoloration [2 Year]
A = There is no visual evidence of marginal discoloration different from the color of the restorative material and from the color the adjacent tooth structure. B = There is visual evidence of marginal discoloration at the junction of the tooth structure and the restoration, but the discoloration has not penetrated along the restoration in a pulpal direction. C = There is visual evidence of marginal discoloration at the junction of the tooth structure and the restoration that has penetrated along the restoration in a pulpal direction.
- Margin Discoloration [3 Year]
A = There is no visual evidence of marginal discoloration different from the color of the restorative material and from the color the adjacent tooth structure. B = There is visual evidence of marginal discoloration at the junction of the tooth structure and the restoration, but the discoloration has not penetrated along the restoration in a pulpal direction. C = There is visual evidence of marginal discoloration at the junction of the tooth structure and the restoration that has penetrated along the restoration in a pulpal direction.
- Proximal Contacts [6 Months]
A = Tight proximal contacts evaluated with dental floss. B = Proximal contacts are weak but present. C = No proximal contacts but not visibly open. D = Visibly open contacts.
- Proximal Contacts [1 Year]
A = Tight proximal contacts evaluated with dental floss. B = Proximal contacts are weak but present. C = No proximal contacts but not visibly open. D = Visibly open contacts.
- Proximal Contacts [2 Year]
A = Tight proximal contacts evaluated with dental floss. B = Proximal contacts are weak but present. C = No proximal contacts but not visibly open. D = Visibly open contacts.
- Proximal Contacts [3 Year]
A = Tight proximal contacts evaluated with dental floss. B = Proximal contacts are weak but present. C = No proximal contacts but not visibly open. D = Visibly open contacts.
- Caries [6 Months]
A = Absent B = Present
- Caries [1 Year]
A = Absent B = Present
- Caries [2 Year]
A = Absent B = Present
- Caries [3 Year]
A = Absent B = Present
- Sensitivity [6 Months]
Visual to Analog scale; 0=no pain, 10=maximum pain
- Sensitivity [1 Year]
Visual to Analog scale; 0=no pain, 10=maximum pain
- Sensitivity [2 Year]
Visual to Analog scale; 0=no pain, 10=maximum pain
- Sensitivity [3 Year]
Visual to Analog scale; 0=no pain, 10=maximum pain
Eligibility Criteria
Criteria
Inclusion Criteria:
-
must have given written informed consent to participate in the trial
-
must need at least three posterior dental fillings
-
replacement restorations due to caries or an esthetic replacement with or without caries are acceptable.
-
must be available for the required post-operative follow-up visits
-
restorations must be in contact with opposing natural or crowned teeth with at least at least one occlusal contact in habitual closure
-
Class II restorations must have at least one proximal contact
-
restorations must have a buccal to lingual/palatal width no greater than 1/3 the distance from buccal to lingual/palatal cusp tips
-
all restorations must Class II with a proximal contact with a natural or artificial tooth
Exclusion Criteria:
-
have severe medical complications (organ transplants, long term antibiotic or steroid treatment, cancer or immunocompromised) and disabilities who 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 or Sjogren's syndrome patients
-
have chronic periodontitis, rampant caries or poor oral hygiene which may require extraction of the teeth to be restored
-
are unavailable for long term recall
-
cannot tolerate the rubber dam required for isolation of the tooth during preparation and restoration.
-
do not meet all inclusion criteria
-
present with any systemic or local disorders that contra-indicate the dental procedures included in this study
-
have an unstable occlusion
-
have severe bruxing or clenching or in need of TMJ related therapy
-
have teeth with periapical pathology or expected pulp exposures
-
have teeth that are non-vital or that exhibit signs of pulpal pathology
-
are pregnant.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Alabama at Birmingham Dental School | Birmingham | Alabama | United States | 35233-2005 |
Sponsors and Collaborators
- 3M
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CR16-005