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

Primary Purpose

Secondary Caries, Fracture Tooth, Discoloration, Tooth

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
giomer
high viscosity glass ionomer
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Secondary Caries focused on measuring Tooth Caries, Discoloration, Tooth

Eligibility Criteria

12 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Children's Cancer Hospital Egypt 57357Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

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

high viscosity glass ionomer (Equia Fil ) in ART

Arm Description

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

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

Outcomes

Primary Outcome Measures

recurrence of caries
Modified USPHS criteria

Secondary Outcome Measures

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

Full Information

First Posted
July 15, 2022
Last Updated
February 7, 2023
Sponsor
Cairo University
Collaborators
Children's Cancer Hospital Egypt 57357
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1. Study Identification

Unique Protocol Identification Number
NCT05465369
Brief Title
Clinical Assessment of Injectable Flowable Composite With Giomer Technology vs High Viscosity Glass Ionomer Restorations in ART for Cancer Patients
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 20, 2023 (Actual)
Primary Completion Date
January 5, 2024 (Anticipated)
Study Completion Date
January 16, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
Collaborators
Children's Cancer Hospital Egypt 57357

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Secondary Caries, Fracture Tooth, Discoloration, Tooth
Keywords
Tooth Caries, Discoloration, Tooth

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
28 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
injectable flowable composite with giomer technology (beatifil flow plus x)
Arm Type
Experimental
Arm Description
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
Arm Title
high viscosity glass ionomer (Equia Fil ) in ART
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Other
Intervention Name(s)
giomer
Other Intervention Name(s)
Beautifil Flow Plus X
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
high viscosity glass ionomer
Other Intervention Name(s)
Equia fill
Intervention Description
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
Primary Outcome Measure Information:
Title
recurrence of caries
Description
Modified USPHS criteria
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Restoration clinical performance
Description
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
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Menna shawkey, master
Phone
01004465544
Email
mennatallah.shawkey@dentistry.cu.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Doaa albeltagi
Phone
01122553556
Email
doaa.albeltagi@57357.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
menna ahmed shawkey, masters
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rawda Hisham abd elaziiz
Organizational Affiliation
Cairo University
Official's Role
Study Chair
Facility Information:
Facility Name
Children's Cancer Hospital Egypt 57357
City
Cairo
State/Province
El Sayeda Zeinab
ZIP/Postal Code
11617
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Doaa Mohamed Albeltagi, Bsph
Phone
0225351500
Ext
7209
Email
doaa.albeltagi@57357.org

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

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

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