Regenerative InflammationPhase 1/2RegenerationNCT07097688
Regenerative Endodontic Treatment Using Sodium Hexametaphosphate (SHMP) For Necrotic Immature Permanent Anterior Teeth
A Phase 1/2 study testing Sodium Hexametaphosphate (SHMP) Inorganic polyphosphates (poly[P]) are linear polymers of orthophosphate (Pi) residues linked by energy-rich phosphoranhydride bonds, Ithas multiple physiological funct in people with Regenerative Inflammation, run by Ahmad Elheeny at 1 site in Egypt.
Trial summary
evaluate clinically and radiographically regenerative potential of sodium hexametaphosphate (SHMP) on stem cells from the apical papilla for 18-month randomized controlled trial Read more about this study
- Who is it for?
- Ages 7 to 11 years
- Conditions the study is for
- Regenerative Inflammation
- What is being tested?
- Sodium Hexametaphosphate (SHMP) Inorganic polyphosphates (poly[P]) are linear polymers of orthophosphate (Pi) residues linked by energy-rich phosphoranhydride bonds, Ithas multiple physiological funct
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 29 Jun 2025to 1 Apr 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Presence of necrotic anterior immature teeth. Parents accepting the treatment modality.History, clinical and radiographic examination reveals absence of pulp vitality Patient abruptly health
Who cannot join
- Tooth mobility. Children who will not comply to recall program. Teeth with history of recurrent periapical pathosis. Hypersensitivity to any material used.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Regenerative Endodontic Treatment Using Sodium Hexametaphosphate (SHMP) For Necrotic Immature Permanent Anterior Teeth: In Vivo And In Vitro Study
evaluate clinically and radiographically regenerative potential of sodium hexametaphosphate (SHMP) on stem cells from the apical papilla for 18-month randomized controlled trial
Read the 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
- Being tested
- Sodium Hexametaphosphate (SHMP) Inorganic polyphosphates (poly[P]) are linear polymers of orthophosphate (Pi) residues linked by energy-rich phosphoranhydride bonds, Ithas multiple physiological funct
- Keywords
- regeneration ,immature teeth ,sodiumhexametaphosphate ,MTA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium Hexametaphosphate (SHMP) Inorganic polyphosphates (poly[P]) are linear polymers of orthophosphate (Pi) residues linked by energy-rich phosphoranhydride bonds, Ithas multiple physiological functBiological
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
| Study group | Role | What they receive |
|---|---|---|
| Sodium Hexametaphosphate | Active comparator | dental material Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Normal responses to percussion, palpation, and normal pocket probing depths, and a positive response to pulp test
pulp sensibility test
Measured: one year
Absence of signs and symptoms of pain, absence of mobility or periapical lesion
PALS scale
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2025
- Study start29 Jun 2025
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Regenerative InflammationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ahmad Elheeny
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ahmad Elheeny, Minia University
- Investigators
- minia university, Principal investigator, minia university faculty of dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07097688
- Sponsor's protocol ID
- Regenerative Endodontic Treatm
- Acronym
- Regeneration
- Status last verified
- Jul 2025
- First submitted
- 1 Jul 2025
- Last updated
- 31 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All patients and their caregivers will be informed in an easy detailed manner about the treatment procedures, expected outcome of the current treatment, possibility of any complications and assuring them to presence of plan B in case of any complication. Verbal assent will be obtained from all children who will accept participation in the study, Parents will sign an informed consent laid down by ethical committee of Faculty of Dentistry / Minia University
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regenerative Endodontic Treatment Using Sodium Hexametaphosphate (SHMP) For Necrotic Immature Permanent Anterior Teeth: In Vivo And In Vitro Study
- ClinicalTrials.gov ID
- NCT07097688
- Acronym / sponsor ID
- Regeneration / Regenerative Endodontic Treatm
- Conditions
- Regenerative Inflammation
- Keywords
- regeneration ,immature teeth ,sodiumhexametaphosphate ,MTA
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ahmad ElheenyUniversity, hospital or other
- Study start
- 29 Jun 2025 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 31 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Sodium Hexametaphosphate | Active comparator | Biological: Sodium Hexametaphosphate (SHMP) Inorganic polyphosphates (poly[P]) are linear polymers of orthophosphate (Pi) residues linked by energy-rich phosphoranhydride bonds, Ithas multiple physiological functdental material |
| Mineral Trio oxide Aggregate | No intervention | –dental biological and compatible material |
Who may qualify
- Ages
- 7 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Presence of necrotic anterior immature teeth. Parents accepting the treatment modality.History, clinical and radiographic examination reveals absence of pulp vitality Patient abruptly health
Key exclusion criteria (1 listed)
- Tooth mobility. Children who will not comply to recall program. Teeth with history of recurrent periapical pathosis. Hypersensitivity to any material used.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sodium Hexametaphosphate (SHMP) Inorganic polyphosphates (poly[P]) are linear polymers of orthophosphate (Pi) residues linked by energy-rich phosphoranhydride bonds, Ithas multiple physiological functThe 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 | Biological | Sodium Hexametaphosphate |
Primary outcome
Normal responses to percussion, palpation, and normal pocket probing depths, and a positive response to pulp test
Time frame: one year
pulp sensibility test
Absence of signs and symptoms of pain, absence of mobility or periapical lesion
Time frame: one year
PALS scale
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2025.
- Individual participant dataSharing planned: No. All patients and their caregivers will be informed in an easy detailed manner about the treatment procedures, expected outcome of the current treatment, possibility of any complications and assuring them to presence of plan B in case of any complication. Verbal assent will be obtained from all children who will accept participation in the study, Parents will sign an informed consent laid down by ethical committee of Faculty of Dentistry / Minia University
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
minia university principal investigator
minia university faculty of dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Sodium Hexametaphosphate (SHMP) Inorganic polyphosphates (poly[P]) are linear polymers of orthophosphate (Pi) residues linked by energy-rich phosphoranhydride bonds, Ithas multiple physiological funct in people with Regenerative Inflammation, run by Ahmad Elheeny at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 31 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Normal responses to percussion, palpation, and normal pocket probing depths, and a positive response to pulp test (time frame: one year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2025.