Ignite Creation Date:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2026-01-01 @ 2:36 PM
Study NCT ID:
NCT05465369
Status:
COMPLETED
Last Update Posted:
2024-09-25
First Post:
2022-07-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Assessment of Injectable Flowable Composite with Giomer Technology Vs High Viscosity Glass Ionomer Restorations in ART for Cancer Patients
Sponsor:
Cairo University
Organization:
Study Overview
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)
Status:
COMPLETED
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: