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

Clinical Assessment Of Injectable Flowable Composite With Giomer Based Technology Versus High Viscosity Glass Ionomer Restorations in Atraumatic Restorative Treatment (ART) For Cancer Patients (One Year Randomized Clinical Trial)

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

Study Overview

• Status: Recruiting
• Conditions: Discoloration, Tooth; Secondary Caries; Fracture Tooth
• Intervention / Treatment: Other: giomer; Other: high viscosity glass ionomer

Detailed Description

Statement of the problem:

Chemotherapy and radiation therapy may cause changes in the lining of the mouth and the salivary glands. This can upset the healthy balance of bacteria. These changes may lead to mouth sores, infections, and tooth decay.

Rationale:

Patients under chemotherapy treatment and radiotherapy are systemically compromised and undergo hospital manipulations and residency, increasing their caries risk, fear, and anxiety. That's why they need specific caries preventive protocols designed for high-risk patients. Atraumatic restorative treatment (ART) is recommended for these patients to decrease pain and anxiety.

Atraumatic restorative treatment (ART) and interim therapeutic restoration (ITR) have had increased interest in the past few years. ART and ITR are comparative approaches and are performed utilizing the same material, but they contrast within the reason of their utilize. ART is very effective as a restorative technique since it is more conservative than conventional treatment. Also in this technique, we avoid using rotary equipment and dental anaesthesia, which increase anxiety during the dental procedure. ITR, on the other hand, is used as a temporary restoration that will be replaced with a more definitive one.

Injectable flowable Giomer composites are a material used for direct filling techniques has been developed over the past years. It has the property of Giomer technology that is 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 (Beautiful flow plus x) has a long-term clinical performance like conventional composite., it also aids in decreasing acid production and formation of an antiacid resistant layer, helps in the reduction of tooth mineral solubility also has a high survival rate and wear resistance in high stress-bearing areas in posterior teeth.

Beautiful Flow Plus X also helps to remineralise the tooth structure for sustainable caries prevention and easily polishes for long-lasting lustre

• Study Type: Interventional
• Enrollment (Anticipated): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • El Sayeda Zeinab
    • Cairo, El Sayeda Zeinab, Egypt, 11617
      • Recruiting
      • Children's Cancer Hospital Egypt 57357

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: injectable flowable composite with giomer technology (beatifil flow plus x); 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; 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 Names: Beautifil Flow Plus X
ACTIVE_COMPARATOR: high viscosity glass ionomer (Equia Fil ) in ART; 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; 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 Names: Equia fill

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
recurrence of caries	Modified USPHS criteria	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Restoration clinical performance	Color match Alfa: no change in color Bravo: change in color Marginal discoloration Alfa: no discoloration bravo: discoloration for less than one - half of the margins Charlie: discoloration for more than one -half of margin Relapse of caries Alfa: no caries present Charlie: caries present Anatomical shape Alfa: clinically ideal Bravo: clinically acceptable Charlie: clinically unacceptable Marginal integrity Alfa: Closely adapted, no visible crevice Bravo: Visible crevice, explorer will penetrate Surface texture Alfa: no defect Bravo: minimal defects Charlie: severe defects rest of modified usphs criteria	12 months

Collaborators and Investigators

• Sponsor: Cairo University
• Collaborators: Children's Cancer Hospital Egypt 57357

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 20, 2023
• Primary Completion (ANTICIPATED): January 5, 2024
• Study Completion (ANTICIPATED): January 16, 2024

Study Registration Dates

• First Submitted: July 15, 2022
• First Submitted That Met QC Criteria: July 15, 2022
• First Posted (ACTUAL): July 19, 2022

Study Record Updates

• Last Update Posted (ESTIMATE): February 9, 2023
• Last Update Submitted That Met QC Criteria: February 7, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Tooth Caries; Discoloration, Tooth
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Tooth Discoloration
• Other Study ID Numbers: OPR 14/8/2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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.

• IPD Sharing Time Frame: the restoration will be evaluated at T0: Baseline T1: 6 months measurement. T2: 12 months measurement.

IPD Sharing 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.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No