NCT07097688

Regenerative Endodontic Treatment Using Sodium Hexametaphosphate (SHMP) For Necrotic Immature Permanent Anterior Teeth

Regenerative Endodontic Treatment Using Sodium Hexametaphosphate (SHMP) For Necrotic Immature Permanent Anterior Teeth: In Vivo And In Vitro Study

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Ahmad Elheeny · Academic / Other
• Sex: All
• Age: 7 Years – 11 Years
• Healthy volunteers: Not accepted

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

Conditions

• Regenerative Inflammation

Interventions

Type	Name	Description
BIOLOGICAL	Sodium 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

Timeline

• Start date: 2025-06-29
• Primary completion: 2025-12-01
• Completion: 2026-04-01
• First posted: 2025-07-31
• Last updated: 2025-07-31

Locations

1 site across 1 country: Egypt