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

Primary Purpose

Dental Caries

Status
Not yet recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
DeltaFil
Riva Self Cure HV
Sponsored by
DMG Dental Material Gesellschaft mbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Caries focused on measuring Primary Dentition, Glass ionomer cements, Posterior Class II restorations, DeltaFil, Riva Self Cure HV

Eligibility Criteria

4 Years - 8 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Arthur Sá Earp Neto, Dental School - Pediatric Dentistry Clinic
  • University of Coimbra, Faculty of Medicine, Paediatric and Preventive Dentistry Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

DeltaFil

Riva Self Cure HV

Arm Description

Class II restorations are placed in primary molars after conventional cavity preparation.

Class II restorations are placed in primary molars after conventional cavity preparation.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).
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)

Full Information

First Posted
July 20, 2023
Last Updated
July 20, 2023
Sponsor
DMG Dental Material Gesellschaft mbH
Collaborators
University of Coimbra, University Arthur Sá Earp Neto
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1. Study Identification

Unique Protocol Identification Number
NCT05965297
Brief Title
Comparison of Two GIC's in the Restoration of Posterior Class II Lesions in the Primary Dentition
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 2023 (Anticipated)
Primary Completion Date
August 2027 (Anticipated)
Study Completion Date
August 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
DMG Dental Material Gesellschaft mbH
Collaborators
University of Coimbra, University Arthur Sá Earp Neto

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries
Keywords
Primary Dentition, Glass ionomer cements, Posterior Class II restorations, DeltaFil, Riva Self Cure HV

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Noninferiority trial
Masking
Participant
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
DeltaFil
Arm Type
Experimental
Arm Description
Class II restorations are placed in primary molars after conventional cavity preparation.
Arm Title
Riva Self Cure HV
Arm Type
Active Comparator
Arm Description
Class II restorations are placed in primary molars after conventional cavity preparation.
Intervention Type
Device
Intervention Name(s)
DeltaFil
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Riva Self Cure HV
Intervention Description
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.
Primary Outcome Measure Information:
Title
Survival rate of Class II restorations
Description
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).
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Survival rate of Class II restorations
Description
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).
Time Frame
6, 12, 36, 48 and 60 months
Title
Individual FDI parameter assessment
Description
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)
Time Frame
Baseline, 6, 12, 24, 36, 48 and 60 months
Other Pre-specified Outcome Measures:
Title
Caries Experience
Description
To assess caries experience the dmft score will be recorded. dmft refers to the number of primary teeth (t) with either decay (d), missing due to caries (m) or a filling (f).
Time Frame
Baseline, 6, 12, 24, 36, 48 and 60 months
Title
Oral Hygiene
Description
Oral hygiene will be assessed using the Oral Hygiene Index-Simplified (OHI-S).
Time Frame
Baseline, 6, 12, 24, 36, 48 and 60 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marcus Cebula, Dr.
Phone
+494084006
Ext
232
Email
mcebula@mtcompanies.com
First Name & Middle Initial & Last Name or Official Title & Degree
Susanne Effenberger, Dr.
Email
seffenberger@mtcompanies.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susanne Effenberger, Dr.
Organizational Affiliation
DMG Dental Material Gesellschaft mbH
Official's Role
Study Chair
Facility Information:
Facility Name
University Arthur Sá Earp Neto, Dental School - Pediatric Dentistry Clinic
City
Petrópolis
Country
Brazil
Facility Name
University of Coimbra, Faculty of Medicine, Paediatric and Preventive Dentistry Institute
City
Coimbra
Country
Portugal
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ana Luísa Costa, Prof.
Email
aluisacosta@sapo.pt
First Name & Middle Initial & Last Name & Degree
Maria Teresa Xavier, Prof.
Email
xavier.teresa@gmail.com
First Name & Middle Initial & Last Name & Degree
Ana Luísa Costa, Prof.
First Name & Middle Initial & Last Name & Degree
Maria Teresa Xavier, Prof.

12. IPD Sharing Statement

Citations:
PubMed Identifier
20628774
Citation
Hickel R, Peschke A, Tyas M, Mjor I, Bayne S, Peters M, Hiller KA, Randall R, Vanherle G, Heintze SD. FDI World Dental Federation: clinical criteria for the evaluation of direct and indirect restorations-update and clinical examples. Clin Oral Investig. 2010 Aug;14(4):349-66. doi: 10.1007/s00784-010-0432-8. Epub 2010 Jul 14.
Results Reference
background

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

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