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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-29

Study Completion Date

2026-04-01

Brief Summary

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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

Detailed Description

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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

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Regenerative Inflammation

Keywords

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regeneration ,immature teeth ,sodiumhexametaphosphate ,MTA

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

-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 Groups

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Sodium Hexametaphosphate

dental material

Group Type ACTIVE_COMPARATOR

Sodium Hexametaphosphate (SHMP) Inorganic polyphosphates (poly[P]) are linear polymers of orthophosphate (Pi) residues linked by energy-rich phosphoranhydride bonds, Ithas multiple physiological funct

Intervention Type 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

Mineral Trio oxide Aggregate

dental biological and compatible material

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

Minimum Eligible Age

7 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Ahmad Elheeny

Assistant professor of Pediatric and Community Dentistry, Faculty of Dentistry, Minia University

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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minia university

Role: PRINCIPAL_INVESTIGATOR

minia university faculty of dentistry

Locations

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Faculty of Dentistry

Minya, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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