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

July 20, 2023 updated by: DMG Dental Material Gesellschaft mbH

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Estimated)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Brazil
      • Petrópolis, Brazil
        • University Arthur Sá Earp Neto, Dental School - Pediatric Dentistry Clinic
  • Portugal
      • Coimbra, Portugal
        • University of Coimbra, Faculty of Medicine, Paediatric and Preventive Dentistry Institute
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ana Luísa Costa, Prof.
        • Principal Investigator:
          • Maria Teresa Xavier, Prof.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DeltaFil
Class II restorations are placed in primary molars after conventional cavity preparation.
Device: DeltaFil
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.
Active Comparator: Riva Self Cure HV
Class II restorations are placed in primary molars after conventional cavity preparation.
Device: Riva Self Cure HV
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival rate of Class II restorations
Time Frame: 24 months
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
Time Frame: 6, 12, 36, 48 and 60 months
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
Time Frame: Baseline, 6, 12, 24, 36, 48 and 60 months

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Caries Experience
Time Frame: Baseline, 6, 12, 24, 36, 48 and 60 months
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).
Baseline, 6, 12, 24, 36, 48 and 60 months
Oral Hygiene
Time Frame: Baseline, 6, 12, 24, 36, 48 and 60 months
Oral hygiene will be assessed using the Oral Hygiene Index-Simplified (OHI-S).
Baseline, 6, 12, 24, 36, 48 and 60 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

DMG Dental Material Gesellschaft mbH

Collaborators

University of Coimbra
University Arthur Sá Earp Neto

Investigators

  • Study Chair: Susanne Effenberger, Dr., DMG Dental Material Gesellschaft mbH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2023

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

August 1, 2030

Study Registration Dates

First Submitted

July 20, 2023

First Submitted That Met QC Criteria

July 20, 2023

First Posted (Actual)

July 28, 2023

Study Record Updates

Last Update Posted (Actual)

July 28, 2023

Last Update Submitted That Met QC Criteria

July 20, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DeltaFill

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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