Trial With Two New Tooth-colored Restorative Materials in Class /II Cavities

Study Overview
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Brief Summary
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This is a randomized-controlled clinical trial to investigate the success rate of two new tooth-colored restorative materials in class I and II cavities over 5 years according to FDI criteria scores (1, 2 and 3).

Detailed Description
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The primary outcome of the study is the SUCCESS RATE of restorations placed with both filling materials in class I and II cavities after 5 years of clinical service. A failure which leads to repair or replacement of the restoration can have esthetic (marginal staining, loss of anatomical form), functional (i.e. fracture of restoration, loss of retention) or biological reasons (i.e. secondary caries). A restoration is defined as a failure (no success) as soon as at least one FDI criterion is scored as 4 or 5.

Official Title
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Randomized Controlled Clinical Trial (RCT) of the New Tooth-colored Restorative Material 'Cention Forte' (Ivoclar Vivadent) vs. 'Equia Forte HT' (GC) in Class-I/II Cavities

Conditions
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Caries, Defective Restorations

Intervention / Treatment
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* Device: Alcasite restorative material
* Device: Bulk fill glass hybrid restorative material


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject's age between 18 and 65 years old Class I and Class II (with a cavity margin 1-1.5 mm from the cusp tip) (caries treatment, removal of existing defective amalgam/composite restorations), on premolars/molars Vital teeth 2 restorations per patient: both cavities should have comparable size and dimensions Presence of neighbour tooth and antagonist (molars with no neighbour tooth at the distal side can also be included) Low to moderate caries rate/normal periodontal status with good home care Exclusion Criteria: Hospitalized and medically compromised patients (medical history may not compromise the outcome of the results) Pulp exposure or signs of pulpal infection No signs of pulpitis or hypersensitivity (Visual analog scale < 3 on biting and temperature sensitivity) History of allergy to glass ionomer, acrylate/methacrylate monomers Pregnancy Chronic disease with oral manifestations or primary oral pathology Bad oral hygiene High caries rate or periodontal problems Absence of antagonists Absence of adjacent teeth (except last molar in the row with no neighbour tooth at the distal side)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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
Interventional Model Description: Split-Mouth Design
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Alcasite restorative material<br> | Device: Alcasite restorative material<br>* Cavity preparation, pulp protection (if necessary), placing matrix/ interdental wedge (if necessary), conditioning with primer, mixing alcasite capsula, place restoration, polymerizing and finishing<br>|
| Active Comparator: Bulk fill glass hybrid restorative material<br> | Device: Bulk fill glass hybrid restorative material<br>* Cavity preparation, pulp protection (if necessary), placing matrix/ interdental wedge (if necessary), mixing bulk fill glass hybrid capsula, conditioning, place restoration, apply coating, polymerizing and finishing<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success Rate | assessed following FDI criteria on a scale from 1 very good to 5 unacceptable: e.g. post-operative hypersensitivity, surface lustre, staining, fracture of material, retention, occlusal contour and wear, and colour match of restorations (Success: Scores equal to/above 3) | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success Rate | assessed following FDI criteria on a scale from 1 very good to 5 unacceptable: e.g. post-operative hypersensitivity, surface lustre, staining, fracture of material, retention, occlusal contour and wear, and colour match of restorations (Success: Scores equal to/above 3) | 6 months to 3 years | 
| Survival Rate | assessed following FDI criteria on a scale from 1 very good to 5 unacceptable: e.g. post-operative hypersensitivity, surface lustre, staining, fracture of material, retention, occlusal contour and wear, and colour match of restorations (Survival: Score equal to/above 4) | 6 months to 5 years | 
| Quality criteria (Clinical performance) | assessed following FDI criteria on a scale from 1 very good to 5 unacceptable: e.g. post-operative hypersensitivity, surface lustre, staining, fracture of material, retention, occlusal contour and wear, and colour match of restorations | 6 months to 5 years |