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ACTIVE NOT RECRUITING
NCT07097688
PHASE1/PHASE2

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

Sponsor: Ahmad Elheeny

View on ClinicalTrials.gov

Summary

evaluate clinically and radiographically regenerative potential of sodium hexametaphosphate (SHMP) on stem cells from the apical papilla for 18-month randomized controlled trial

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

Key Details

Gender

All

Age Range

7 Years - 11 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2025-06-29

Completion Date

2026-04-01

Last Updated

2025-07-31

Healthy Volunteers

No

Interventions

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

Locations (1)

Faculty of Dentistry

Minya, Egypt