Clinical trial NCT05465369: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Secondary Caries
Fracture Tooth
Discoloration, Tooth
Keywords: Tooth Caries
Discoloration, Tooth
Lead sponsor: Cairo University
Sponsor class: OTHER
Collaborators: name: Children's Cancer Hospital Egypt 57357
First posted: 2022-07-19
Enrollment: 190
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

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

Primary outcomes:
measure: recurrence of caries
timeFrame: 12 months
Secondary outcomes:
measure: Restoration clinical performance
timeFrame: 12 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Children's Cancer Hospital Egypt 57357
state: El Sayeda Zeinab
Study officials:
affiliation: Cairo University
name: menna ahmed shawkey, masters
role: PRINCIPAL_INVESTIGATOR
affiliation: Cairo University
name: Rawda Hisham abd elaziiz
role: STUDY_CHAIR
References: