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

NCT07097688 | Active Not Recruiting Phase 1 DMC

• 1 other identifier: Regenerative Endodontic Treatm
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Regenerative Inflammation

Keywords

regeneration ,immature teeth ,sodiumhexametaphosphate ,MTA

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Sodium Hexametaphosphate

ACTIVE COMPARATOR

dental material

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

Mineral Trio oxide Aggregate

NO INTERVENTION

dental biological and compatible material

Interventions

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

Sodium Hexametaphosphate

Eligibility Criteria

• Age: 7 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Presence of necrotic anterior immature teeth. Parents accepting the treatment modality.History, clinical and radiographic examination reveals absence of pulp vitality Patient abruptly health

You may not qualify if:

• Tooth mobility. Children who will not comply to recall program. Teeth with history of recurrent periapical pathosis. Hypersensitivity to any material used.

Sponsors & Collaborators

• Ahmad Elheeny: lead

Study Sites (1)

Faculty of Dentistry

Minya, Egypt

Location

MeSH Terms

Interventions

sodium polymetaphosphate

Study Officials

• minia university

  minia university faculty of dentistry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: -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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant professor of Pediatric and Community Dentistry, Faculty of Dentistry, Minia University

Model Details: 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

Study Record Dates

• First Submitted: July 1, 2025
• First Posted: July 31, 2025
• Study Start: June 29, 2025
• Primary Completion: December 1, 2025
• Study Completion: April 1, 2026
• Last Updated: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)