Comparison of Two GIC's in the Restoration of Posterior Class II Lesions in the Primary Dentition

Study Overview
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Brief Summary
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This study will investigate the clinical performance of a novel restorative glass ionomer (DeltaFil, DMG) in comparison to an established restorative glass ionomer (Riva Self Cure HV, SDI) in the restoration of Class II cavities in primary molars.

Detailed Description
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Dental caries (tooth decay) remains one of the most prevalent diseases worldwide. It is a dynamic and continuous process that, if uncontrolled, eventually leads to cavitation and the need for restorative treatment to maintain the form and function of the tooth.Today there are many possibilities for direct restorations, e.g. resin composites, compomers, resin-modified glass ionomer cements (RMGICs) and glass ionomer cements (GICs), which all offer their own advantages and disadvantages. GIC are particularly suitable for treatments in young patients due to their high biocompatibility, fluoride release, less moisture and technique sensitivity as well as compatibility with Atraumatic restorative treatment (ART) treatment. However, these materials have lower mechanical properties compared to other restorative materials, which negatively affects the survival rate when placed in load bearing areas. Fracture, loss and wear being the most common causes for failure. This randomized, controlled non-inferiority trial aims to evaluate the performance of the new restorative glass ionomer DeltaFil, that offers an increased fracture toughness, in comparison to an established restorative glass-ionomer (Riva Self Cure HV).

Official Title
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Comparison of Two Conventional Glass Ionomer Cements in the Restoration of Posterior Class II Lesion in the Primary Dentition: a Randomized Controlled Non Inferiority Trial

Conditions
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Dental Caries

Intervention / Treatment
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* Device: DeltaFil
* Device: Riva Self Cure HV


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least 1 and up to 3 primary molars with either International Caries Detection and Assessment System (ICDAS) lesions stage 2-5 or preexisting restorations requiring placement/replacement of Class II restorations Defects limited to occlusal-proximal surface, with cavity sizes smaller than 3 mm mesio-distally and 3 mm in the occluso-cervical and bucco-lingual directions measured with a World Health Organization (WHO)-graded periodontal probe Teeth should have both adjoining and their antagonist teeth present. After restoration the restored tooth should enable appropriate proximal contacts on both mesial and distal surfaces after setting of the class II restoration and be in occlusion with the antagonist tooth Good access Good general health (ASA I, II) Good oral hygiene (OHI-S < 1.9) Guardians have given informed consent Child is cooperative and assented Exclusion Criteria: Known allergy/ sensitivity to GIC or other materials used in this study Space maintainers or orthodontic appliances Tooth has a caries lesion or restoration other than those included in the study Tooth has pathological mobility Tooth has preexisting developmental defects Tooth with pulp exposure or indication for endodontic treatment Pain, fistula or abscess related to the selected tooth Obvious signs of parafunctional habits (e.g. bruxism) Participation in another study Incapable to participate in the recall visits at the university hospital

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 8 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: Noninferiority trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DeltaFil<br>Class II restorations are placed in primary molars after conventional cavity preparation. | Device: DeltaFil<br>* Cavities are prepared using rotary instruments/diamond burs. Afterwards, the cavity is conditioned (using DeltaFil conditioner) and cleaned, with subsequent insertion of a conventional restorative glass-ionomer (DeltaFil). During the curing phase and after finishing Riva Coat will be applied to all restoration surfaces for moisture protection.<br>|
| Active Comparator: Riva Self Cure HV<br>Class II restorations are placed in primary molars after conventional cavity preparation. | Device: Riva Self Cure HV<br>* Cavities are prepared using rotary instruments/diamond burs. Afterwards, the cavity is conditioned (using Riva conditioner) and cleaned, with subsequent insertion of a conventional restorative glass-ionomer (Riva Self Cure HV). During the curing phase and after finishing Riva Coat will be applied to all restoration surfaces for moisture protection.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival rate of Class II restorations | Restorations are clinically assessed using the Fédération Dentaire Internationale (FDI) criteria. A surviving restoration is defined as a restoration that is still present at the time of evaluation and has no individual FDI criteria with a score of 5 (clinically poor). | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival rate of Class II restorations | Restorations are clinically assessed using the FDI criteria. A surviving restoration is defined as a restoration that is still present at the time of evaluation and has no individual FDI criteria with a score of 5 (clinically poor). | 6, 12, 36, 48 and 60 months | 
| Individual FDI parameter assessment | Restorations are clinically assessed using the FDI criteria. Specifically, the following criteria are assessed individually on a scale from 1 very good to 5 clinicially poor: Esthetic properties (Surface Luster; Surface Staining; Color Match; Anatomical Form); Functional properties (Fractures and Retention; Wear; Approximal Contact Point and Contour; Patient view); Biological properties (Postoperative Hypersensitivity & Tooth Vitality; Recurrence of Caries, Erosion, Abfraction; Periodontal Response; Tooth Integrity;Adjacent mucosa) | Baseline, 6, 12, 24, 36, 48 and 60 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Primary Dentition, Glass ionomer cements, Posterior Class II restorations, DeltaFil, Riva Self Cure HV