Clinical Assessment of Injectable Flowable Composite with Giomer Technology Vs High Viscosity Glass Ionomer Restorations in ART for Cancer Patients

NCT05465369 | Completed Phase 3

• 1 other identifier: OPR 14/8/2022
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 1

Brief Summary

Aim of the Study: This study will compare between injectable flowable composite (Beautifil flow plus x) and high viscosity glass ionomer (Equia Fil) by ART caries preventive protocol in high caries risk patients receiving chemotherapy and/or radiotherapy

Conditions

Secondary Caries; Fracture Tooth; Discoloration, Tooth

Keywords

Tooth Caries; Discoloration, Tooth

Outcome Measures

Primary Outcomes (1)

• recurrence of caries

  Modified USPHS criteria

  12 months

Secondary Outcomes (1)

• Restoration clinical performance

  12 months

Study Arms (2)

injectable flowable composite with giomer technology (beatifil flow plus x)

EXPERIMENTAL

Injectable flowable Giomer composites is a material used for direct filling techniques has been developed over the past years. It has the property of Giomer technology that able to release and recharge fluoride and other beneficial ions for the life of the restoration and induce remineralization of the underlying hard dental tissues . Injectable flowable Giomer composite (Beautifil flow plus x) has a long-term clinical performance like conventional composite., it also aids in decrease acid production and formation of antiacid resistant layer, help in reduction of tooth mineral solubility also it has high survival rate and wear resistance in high stress bearing areas in posterior teeth Beautifil Flow Plus X also helps to remineralise the tooth structure for sustainable caries prevention and easily polishes for long-lasting luster

Other: giomer

high viscosity glass ionomer (Equia Fil ) in ART

ACTIVE COMPARATOR

High viscous glass ionomer, the most suitable restorative material for ART procedure and can be used outside the dental clinic, which increases the opportunity for dental care , using a high-viscosity glass-ionomer as an ART sealant in both primary and permanent posterior teeth have a high caries preventive effect High viscosity glass ionomer (EQUIA Fil) has new technology involves ultrafine, and highly reactive glass diffused within the glass-ionomer fillers to increase and enhance matrix formation. This system allows ion availability and builds a stronger matrix structure with greater physical properties, wear resistance and fluoride release. Mechanical properties and fluoride release is the most important features to evaluate glass ionomer restorative material and it's proven that EQUIA Fil fulfilled all these requirement

Other: high viscosity glass ionomer

Interventions

giomer OTHER

injectable flowable Giomer composites is a material used for direct filling techniques has been developed over the past years. It has the property of Giomer technology that able to release and recharge fluoride and other beneficial ions for the life of the restoration and induce remineralization of the underlying hard dental tissues . Injectable flowable Giomer composite (Beautifil flow plus x) has a long-term clinical performance like conventional composite., it also aids in decrease acid production and formation of antiacid resistant layer, help in reduction of tooth mineral solubility also it has high survival rate and wear resistance in high stress bearing areas in posterior teeth Beautifil Flow Plus X also helps to remineralise the tooth structure for sustainable caries prevention and easily polishes for long-lasting luster

Also known as: Beautifil Flow Plus X

injectable flowable composite with giomer technology (beatifil flow plus x)

high viscosity glass ionomer OTHER

High viscous glass ionomer, the most suitable restorative material for ART procedure and can be used outside the dental clinic, which increases the opportunity for dental care , using a high-viscosity glass-ionomer as an ART sealant in both primary and permanent posterior teeth have a high caries preventive effect High viscosity glass ionomer (EQUIA Fil) has new technology involves ultrafine, and highly reactive glass diffused within the glass-ionomer fillers to increase and enhance matrix formation. This system allows ion availability and builds a stronger matrix structure with greater physical properties, wear resistance and fluoride release. Mechanical properties and fluoride release is the most important features to evaluate glass ionomer restorative material and it's proven that EQUIA Fil fulfilled all these requirement

Also known as: Equia fill

high viscosity glass ionomer (Equia Fil ) in ART

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• existing caries in permanent posterior teeth
• Permanent posterior teeth with active carious lesion class I and class II without any signs and symptoms of pulp disease.
• Teeth in normal occlusion
• Absence of any active periodontal disease.

You may not qualify if:

• Patients whose systemic involvement was too advanced to allow dental manipulation, such as those who were admitted to the intensive care unit
• Patients with parafunctional habits
• Presence of any sign or symptoms of irreversible Pulpitis or necrotic pulp
• Partially erupted teeth

Sponsors & Collaborators

• Cairo University: lead
• Children's Cancer Hospital Egypt 57357: collaborator

Study Sites (1)

Children's Cancer Hospital Egypt 57357

Cairo, El Sayeda Zeinab, 11617, Egypt

Location

MeSH Terms

Conditions

Tooth Fractures; Tooth Discoloration; Dental Caries

Condition Hierarchy (Ancestors)

Tooth Injuries; Tooth Diseases; Stomatognathic Diseases; Wounds and Injuries; Tooth Demineralization

Study Officials

• menna ahmed shawkey, masters

  Cairo University

  PRINCIPAL INVESTIGATOR

• Rawda Hisham abd elaziiz

  Cairo University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master's degree student ,faculty of dentistry

Study Record Dates

• First Submitted: July 15, 2022
• First Posted: July 19, 2022
• Study Start: February 7, 2023
• Primary Completion: May 15, 2024
• Study Completion: May 15, 2024
• Last Updated: September 25, 2024

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: the restoration will be evaluated at T0: Baseline T1: 6 months measurement. T2: 12 months measurement.
• Access Criteria: Young adult (12-18) years Patients who have existing caries in permanent posterior teeth Teeth inclusion criteria Permanent posterior teeth with active carious lesion class I and class II without any signs and symptoms of pulp disease. Teeth in normal occlusion Absence of any active periodontal disease.

Locations

EG (1)