Regenerative Inflammation
Conditions
Keywords
regeneration ,immature teeth ,sodiumhexametaphosphate ,MTA
Brief summary
evaluate clinically and radiographically regenerative potential of sodium hexametaphosphate (SHMP) on stem cells from the apical papilla for 18-month randomized controlled trial
Detailed description
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
Interventions
BIOLOGICALSodium Hexametaphosphate (SHMP) Inorganic polyphosphates (poly[P]) are linear polymers of orthophosphate (Pi) residues linked by energy-rich phosphoranhydride bonds, Ithas multiple physiological funct
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
Sponsors
Ahmad Elheeny
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Masking description
-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.
Intervention model description
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
Eligibility
Sex/Gender
ALL
Age
7 Years to 11 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Normal responses to percussion, palpation, and normal pocket probing depths, and a positive response to pulp test | one year | pulp sensibility test |
| Absence of signs and symptoms of pain, absence of mobility or periapical lesion | one year | PALS scale |
Countries
Egypt
Outcome results
None listed