Comparative Study of Experimental Dental Adhesive With and Without Phosphoric Acid Pretreatment

Study Overview
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Brief Summary
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The intent of this study is to evaluate the clinical performance of an experimental dental bonding agent for use with dental restorative composites with and without pretreatment of the tooth dentin and enamel using phosphoric acid etching.

Detailed Description
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The intent of this study is to evaluate the clinical performance of an experimental dental bonding agent (adhesive) for use with dental restorative composites with and without pretreatment of the tooth dentin and enamel using phosphoric acid etching.

Official Title
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Clinical Evaluation of an Experimental Universal Adhesive Used With and Without Phosphoric Acid Pretreatment in Posterior Composite Resin Restorations

Conditions
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Dental Caries

Intervention / Treatment
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* Device: Experimental adhesive w/out phosphoric acid in post. rest.
* Device: Experimental adhesive with phosphoric acid in post. rest.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients in need of Class I and Class II restorations in premolars and molars. Exclusion Criteria: Patients with fewer than 20 teeth Patients exhibiting poor oral hygiene or uncontrolled periodontal disease Pregnant women or lactating mothers Patients with known allergies to HEMA or resin-based materials Patients with medical conditions that would contraindicate dental treatment Patients with xerostomia
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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Adhesive without acid pretreatment<br>Experimental adhesive w/out phosphoric acid in post. rest. | Device: Experimental adhesive w/out phosphoric acid in post. rest.<br>* Experimental adhesive without phosphoric acid in posterior restorations<br>|
| Active Comparator: Adhesive with acid pretreatment<br>Experimental adhesive with phosphoric acid in post. rest. | Device: Experimental adhesive with phosphoric acid in post. rest.<br>* Experimental adhesive with phosphoric acid in posterior restorations<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Color Match | The color match will be assessed clinically according to Ryge (1973)* for matching with adjacent teeth and stability of color matching over time. Assessments will be done to the following criteria: Alpha= Restoration matches adjacent tooth structure in shade and/or translucency. Bravo= Mismatch in shade and/or translucency is within normal range of tooth shades. Charlie= Mismatch in shade and/or translucency is outside normal range of tooth shades. *As per the Investigation Protocol, United States Public Health Service (USPHS) direct evaluation procedures were conducted using modified methods reported by Ryge in 1973. As described by Ryge in 1973, the term clinical assessment means a visual examination by a dentist, using a mouth mirror, an explorer, and supplementary lighting as needed. | Baseline, 6 months, 18 months; Note: The 36 month evaluation was an option in the protocol at the time of investigation initiation. The study was concluded at 18 months. Thus 36 month data does not exist. | 
| Marginal Discoloration | Marginal discoloration will be assessed clinically according to Ryge (1973)* over time. Assessments will be done to the following criteria: Alpha= No visual evidence of marginal discoloration. Bravo= Marginal discoloration present but has not penetrated in a pulpal direction. Charlie= Marginal discoloration has penetrated in a pulpal direction. *As per the Investigation Protocol, United States Public Health Service (USPHS) direct evaluation procedures were conducted using modified methods reported by Ryge in 1973. As described by Ryge in 1973, the term clinical assessment means a visual examination by a dentist, using a mouth mirror, an explorer, and supplementary lighting as needed. | Baseline, 6 months, 18 months. Note: The 36 month evaluation was an option in the protocol at the time of investigation initiation. The study was concluded at 18 months. Thus 36 month data does not exist. | 
| Marginal Integrity | Change in marginal integrity will be assessed clinically according to Ryge (1973)* over time. Assessments will be done to the following criteria: A= Explorer does not catch or slight catch with no visible crevice. B= Explorer catches and crevice is visible but no exposure of dentin or base. C= Explorer penetrates crevice and defect extended to amelo-dentinal junction. D= Restoration is fractured, mobile, or missing in part or in toto. *As per the Investigation Protocol, United States Public Health Service (USPHS) direct evaluation procedures were conducted using modified methods reported by Ryge in 1973. As described by Ryge in 1973, the term clinical assessment means a visual examination by a dentist, using a mouth mirror, an explorer, and supplementary lighting as needed. | Baseline, 6 months, 18 months. Note: The 36 month evaluation was an option in the protocol at the time of investigation initiation. The study was concluded at 18 months. Thus 36 month data does not exist. | 
| Presence of Secondary Dental Caries (Cavities) | Change in presence of secondary dental caries will be assessed clinically according to Ryge (1973)* over time. Assessments will be done to the following criteria: A= No caries present. D= Caries present associated with the restoration. *As per the Investigation Protocol, United States Public Health Service (USPHS) direct evaluation procedures were conducted using modified methods reported by Ryge in 1973. As described by Ryge in 1973, the term clinical assessment means a visual examination by a dentist, using a mouth mirror, an explorer, and supplementary lighting as needed. Note: Secondary caries is a categorical, dichotomous variable, i.e. there is caries or not. This was assessed clinically and radiographically by a trained professional (dentist). | Baseline, 6 months, 18 months; Note: The 36 month evaluation was an option in the protocol at the time of investigation initiation. The study was concluded at 18 months. Thus 36 month data does not exist. | 
| Presence of Restoration Fractures (Localized or Bulk) | The restoration will be assessed clinically according to Ryge (1973)* for presence of fractures over time. Assessments will be done to the following criteria: A= Smooth restoration surface with no irregularities. B= Slightly rough or pitted restoration surface. Can be refinished. C= Deeply pitted or grooved (not related to anatomy) restoration finish. Can not be refinished. D= Restoration surface is fractured or flaking. *As per the Investigation Protocol, United States Public Health Service (USPHS) direct evaluation procedures were conducted using modified methods reported by Ryge in 1973. As described by Ryge in 1973, the term clinical assessment means a visual examination by a dentist, using a mouth mirror, an explorer, and supplementary lighting as needed. | Baseline, 6 months, 18 months; Note: The 36 month evaluation was an option in the protocol at the time of investigation initiation. The study was concluded at 18 months. Thus 36 month data does not exist. | 
| Post-operative Sensitivity | Patient will be interviewed to assess post-operative sensitivity according to the following criteria: A= No sensitivity. B= Mild sensitivity. C= Moderate sensitivity with no restoration replacement required. D= Sever sensitivity. Replacement of restoration is required. Tooth sensitivity will be assessed at baseline and each follow-up appointment using cold thermal test (Endo-Ice, Hygienic) and Electric Pulp Test (EPT) when indicated. | Baseline, 6 months, 18 months; Note: The 36 month evaluation was an option in the protocol at the time of investigation initiation. The study was concluded at 18 months. Thus 36 month data does not exist. | 
| Surface Condition of Restoration | The change in surface condition of restoration will be assessed clinically according to Ryge (1973)* over time. Assessments will be done to the following criteria: A= Restoration is continuous with existing anatomic form. B= Restoration is discontinuous with existing anatomic form but missing material is not sufficient to expose dentin or lining. C= Sufficient restorative material is lost to expose dentin. *As per the Investigation Protocol, United States Public Health Service (USPHS) direct evaluation procedures were conducted using modified methods reported by Ryge in 1973. As described by Ryge in 1973, the term clinical assessment means a visual examination by a dentist, using a mouth mirror, an explorer, and supplementary lighting as needed. | Baseline, 6 months, 18 months; Note: The 36 month evaluation was an option in the protocol at the time of investigation initiation. The study was concluded at 18 months. Thus 36 month data does not exist. | 
| Gingival Inflammation Index | Patient's gingiva will be assessed clinically according to Ryge (1973)* over time. Assessments will be done to the following criteria: 0 = Normal gingiva. = Mild inflammation, slight change in color, slight edema, no bleeding upon probing. = Moderate inflammation, redness; edema and glazing; bleeding upon palpation. = Severe inflammation, marked redness and edema, ulceration, tendency to spontaneous bleeding. As described by Ryge in 1973, the term clinical assessment means a visual examination by a dentist, using a mouth mirror, an explorer, and supplementary lighting as needed. Note: At 6 months data was not reported. At Baseline, all patients presented a score of 0. Any patient with a score greater than zero would have been excluded at baseline. Patients who received Class I restorations were not assessed as these restorations are limited to the chewing surface and not related to the health of gums. | 18 months; Note: The 36 month evaluation was an option in the protocol at the time of investigation initiation. The study was concluded at 18 months. Thus 36 month data does not exist. |