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evaluate clinically and radiographically regenerative potential of sodium hexametaphosphate (SHMP) on stem cells from the apical papilla for 18-month randomized controlled trial
7 to 11 years old will be selected with no sex predilection for the study from out patients of Pediatric and Community Dentistry Department, Minia University, according to the following eligibility criteria and evaluate clinically and radiographically regenerative potential of sodium hexametaphosphate (SHMP) on stem cells from the apical papilla for 18-month randomized controlled trial
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sodium Hexametaphosphate | Active Comparator | dental material |
|
| Mineral Trio oxide Aggregate | No Intervention | dental biological and compatible material |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sodium Hexametaphosphate (SHMP) Inorganic polyphosphates (poly[P]) are linear polymers of orthophosphate (Pi) residues linked by energy-rich phosphoranhydride bonds, Ithas multiple physiological funct | Biological | The study will be with two parallel arms (1:1 allocation ratio). The sample size per group will be calculated according to the following equation for binary outcomes; N = (Zα/2 + Zβ) 2 ×p1(1 - p1) + p2(1 - p2)/δ 2 so the minimal sample size for an equal size clinical trial is 27teeth in each group. We will recruit 30 teeth in each group for possible attrition |
| Measure | Description | Time Frame |
|---|---|---|
| Normal responses to percussion, palpation, and normal pocket probing depths, and a positive response to pulp test | pulp sensibility test | one year |
| Absence of signs and symptoms of pain, absence of mobility or periapical lesion | PALS scale | one year |
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Inclusion Criteria:
Presence of necrotic anterior immature teeth. Parents accepting the treatment modality.History, clinical and radiographic examination reveals absence of pulp vitality Patient abruptly health
Exclusion Criteria:
Tooth mobility. Children who will not comply to recall program. Teeth with history of recurrent periapical pathosis. Hypersensitivity to any material used.
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| Name | Affiliation | Role |
|---|---|---|
| minia university | minia university faculty of dentistry | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dentistry | Minya | Egypt |
All patients and their caregivers will be informed in an easy detailed manner about the treatment procedures, expected outcome of the current treatment, possibility of any complications and assuring them to presence of plan B in case of any complication. Verbal assent will be obtained from all children who will accept participation in the study, Parents will sign an informed consent laid down by ethical committee of Faculty of Dentistry / Minia University
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Included patients will be randomized into one of the study groups. Randomization will be performed using a computer-generated block randomization system (Microsoft office excel, 2007).
Concealment, A plan of management will be sealed in closed envelops, numbered according to the randomization tables.
Packing, sealing and numbering will all be performed by a neutral health care provider other than the investigator
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-Included patients will be randomized into one of the study groups. Randomization will be performed using a computer-generated block randomization system (Microsoft office excel, 2007).
Concealment, A plan of management will be sealed in closed envelops, numbered according to the randomization tables.
Packing, sealing and numbering will all be performed by a neutral health care provider other than the investigator.
|
| ID | Term |
|---|---|
| C009285 | sodium polymetaphosphate |
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