Clinical trial NCT06254053: Clinical and Radiographic Evaluation of Zirconomer Restorative
Official title: Clinical and Radiographic Evaluation of Zirconomer Restorative Material Versus a Glass Ionomer Cement in Restoration of Primary Molars A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Dental Caries in Children
Dental Materials
Keywords: GIc/Zirconomer
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-02-12
Enrollment: 24
Sex: ALL
Minimum age (years): 5
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: last decade has seen several innovative additions to enhance the properties of GIC whilst simplifying its usage. Unlike the early glass-ionomers, these newer systems are easy and more practical to use as a dental restorative and luting material for preschoolers, children and teenagers alike. These new varieties are composed of ceramic and zirconia reinforced glass ionomer cements were introduced to provide better drawbacks of amalgam as well as tooth-colored restorative materials exhibiting the strength of amalgam and at the same time maintain the fluoride releasing capacity of GIC providing better mechanical properties.
Primary purpose: TREATMENT

Brief summary: Is zirconomer restorative material more effective than a glass ionomer cement in restoration of primary molars

Detailed description: This trial seeks to evaluate the clinical and radiographic performance of two materials zirconomer restorative material and glass ionomer cement to achieve better treatment for primary molars.

Eligibility criteria: * Inclusion criteria:

  1. Children having carious primary molars(class1) without pulp exposure and normal radiograph.
  2. Children between age 5 and 7 years.
  3. Both male and female are included.
  4. Cooperative Children.

     Exclusion criteria:

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  1. Patients with systemic diseases.
  2. Parent refuse to participate.

Primary outcomes:
measure: Recurrent CariesColor match
timeFrame: 12 MONTHS
Secondary outcomes:
measure: Color match
timeFrame: 12 MONTHS
measure: Marginal Discoloration
timeFrame: 12 MONTHS
measure: Marginal Adaptation
timeFrame: 12 MONTHS
measure: -Anatomic Form
timeFrame: 12 MONTHS
Other outcomes:
Locations:
Study officials:
affiliation: Cairo University
name: sherien ez zaldein, professor
role: STUDY_DIRECTOR
References:
citation: Nanavati K, Katge F, Chimata VK, Pradhan D, Kamble A, Patil D. Comparative Evaluation of Shear Bond Strength of Bioactive Restorative Material, Zirconia Reinforced Glass Ionomer Cement and Conventional Glass Ionomer Cement to the Dentinal Surface of Primary Molars: an in vitro Study. J Dent (Shiraz). 2021 Dec;22(4):260-266. doi: 10.30476/DENTJODS.2021.87115.1230.
citation: Kukreja R, Singla S, Bhadoria N, Pawar P, Gupta K, Khandelwal D, Dewani N. An In Vitro Study to Compare the Release of Fluoride from Glass Ionomer Cement (Fuji IX) and Zirconomer. Int J Clin Pediatr Dent. 2022 Jan-Feb;15(1):35-37. doi: 10.5005/jp-journals-10005-2141.
citation: undefined
citation: Mushtaq U, Mushtaq F, Thakur D, Rathee K, Poonia N, Khullar S. Comparative Evaluation of Postoperative Sensitivity Following Restoration of Class I Lesions with Different Restorative Materials: An In Vivo Study. J Contemp Dent Pract. 2021 Jun 1;22(6):650-654.
citation: Arora D, Jain M, Suma Sogi HP, Shahi P, Gupta I, Sandhu M. In vivo evaluation of clinical performance of Cention N and glass ionomer cement in proximal restorations of primary molars. J Indian Soc Pedod Prev Dent. 2022 Jan-Mar;40(1):23-29. doi: 10.4103/jisppd.jisppd_108_21.
citation: Albeshti R, Shahid S. Evaluation of Microleakage in Zirconomer(R): A Zirconia Reinforced Glass Ionomer Cement. Acta Stomatol Croat. 2018 Jun;52(2):97-104. doi: 10.15644/asc52/2/2.