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NCT Number: NCT05965297

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

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.

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Key information

Age range

4 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Arthur Sá Earp Neto, Dental School - Pediatric Dentistry Clinic, Petrópolis, Brazil

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DeltaFil

Device

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.

Riva Self Cure HV

Device

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 outcomes

  1. 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).

Secondary outcomes

  1. 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).

  2. 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)

Other outcomes

  1. 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).

  2. 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Marcus Cebula, Dr.

CONTACT

[email protected]

+494084006 ext. 232

Susanne Effenberger, Dr.

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

DMG Dental Material Gesellschaft mbH

Industry

Collaborators

  • University Arthur Sá Earp Neto
  • University of Coimbra

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2027
Study completion
2030
First posted
Jul 28, 2023
Registry last updated
Jul 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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