Discoloration, Tooth Clinical Trial
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)
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
Status | Recruiting |
Enrollment | 28 |
Est. completion date | January 16, 2024 |
Est. primary completion date | January 5, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 12 Years to 18 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Egypt | Children's Cancer Hospital Egypt 57357 | Cairo | El Sayeda Zeinab |
Lead Sponsor | Collaborator |
---|---|
Cairo University | Children's Cancer Hospital Egypt 57357 |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | recurrence of caries | Modified USPHS criteria | 12 months | |
Secondary | 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 |
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