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

Официальное название

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

Обзор

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.

Подробное описание

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).

Вмешательства

• Устройство 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.
• Устройство 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.

Первичные конечные точки

• Survival rate of Class II restorations [Срок оценки: 24 months]

Вторичные конечные точки (2)

• Survival rate of Class II restorations [Срок оценки: 6, 12, 36, 48 and 60 months]
• Individual FDI parameter assessment [Срок оценки: Baseline, 6, 12, 24, 36, 48 and 60 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Бразилия · 1 центр

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

Португалия · 1 центр

• University of Coimbra, Faculty of Medicine, Paediatric and Preventive Dentistry Institute — Coimbra

Публикации

• 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. PMID 20628774

Идентификаторы

NCT: NCT05965297 · DeltaFill

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗