Necrotic PulpNCT05522270
Concentrated Growth Factor Versus Platelet Rich Fibrin in Revitalization of Necrotic Young Permanent Incisors
A study testing revitalization by concentrated growth factor in people with Necrotic Pulp, run by Ahmad Elheeny.
Trial summary
Regenerative endodontic procedures (REPs) are the most recent proposal to manage immature permanent teeth with necrotic pulps. So in this study, the investigator will evaluate the clinical and radiographical revitalization success in necrotic young permanent anterior teeth of participants by using Concentrated Growth… Read more about this study
- Who is it for?
- Ages 6 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Necrotic Pulp
- What is being tested?
- revitalization by concentrated growth factor
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2022to 1 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 6 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy patients with immature permanent incisors
- Presence of clinical signs and symptoms of necrosis or chronic apical periodontitis. The chronic apical periodontitis signs and symptoms include little discomfort with intermittent episodes of pus discharge through the sinus tract.
Who cannot join
- 1. Abnormal tooth mobility.
- Positive history of allergic reaction, systemic diseases, severe emotional or behavioral problems.
- Unrestorable teeth
- Abnormal tooth mobility
- Children with systemic, severe behavioral, or emotional problems
Trial locations and contacts
No sites are listed yet.
About this study
Regenerative endodontic procedures (REPs) are the most recent proposal to manage immature permanent teeth with necrotic pulps. So in this study, the investigator will evaluate the clinical and radiographical revitalization success in necrotic young permanent anterior teeth of participants by using Concentrated Growth Factor versus Platelet-Rich Fibrin
Read the detailed description
has been entered
- Conditions
- Necrotic Pulp
- Being tested
- revitalization by concentrated growth factor
- Medical subject headings
- Dental Pulp Necrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
revitalization by concentrated growth factorProcedure or surgery
Also called revitalization by platelet rich fibrin
modified platelet concentrate
| Study group | Role | What they receive |
|---|---|---|
| revitalization by concentrated growth factor | Experimental | modified platelet concentrate Receives: Procedure: revitalization by concentrated growth factor |
| revitalization by platelet rich fibrin | Active comparator | platelet concentrate Receives: Procedure: revitalization by concentrated growth factor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical success rate
Regaining tooth vitality with electric pulp testing Clinical examination includes pain absence, normal tooth mobility, and no sensitivity to percussion
Measured: one year
Radiographic success using Periapical index (PAI)
Criteria of PAI scores:
score "1" normal periapical structure score "2" small changes in bone structures score "3" changes in bone structure with some mineral loss score "4" periodontitis with well-defined radiolucent area score "5" severe periodontitis with exacerbating features
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 Aug 2022
- Study start1 Sep 2022 (estimated)
- Primary completion1 May 2023 (estimated)
- Study completion1 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Necrotic PulpStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- parallel assignment
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05522270
- Sponsor's protocol ID
- 320
- Status last verified
- Aug 2022
- First submitted
- 22 Aug 2022
- Last updated
- 31 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Concentrated Growth Factor Versus Platelet Rich Fibrin in Revitalization of Necrotic Young Permanent Incisors
- ClinicalTrials.gov ID
- NCT05522270
- Acronym / sponsor ID
- 320
- Conditions
- Necrotic Pulp
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ahmad ElheenyUniversity, hospital or other
- Study start
- 1 Sep 2022 (estimated)
- Primary completion
- 1 May 2023 (estimated)
- Study completion
- 1 Jul 2023 (estimated)
- First posted
- 31 Aug 2022 (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.
Regenerative endodontic procedures (REPs) are the most recent proposal to manage immature permanent teeth with necrotic pulps. So in this study, the investigator will evaluate the clinical and radiographical revitalization success in necrotic young permanent anterior teeth of participants by using Concentrated Growth Factor versus Platelet-Rich Fibrin
Detailed description
has been entered
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- parallel assignment
| Arm | Type | Receives |
|---|---|---|
| revitalization by concentrated growth factor | Experimental | Procedure: revitalization by concentrated growth factormodified platelet concentrate |
| revitalization by platelet rich fibrin | Active comparator | Procedure: revitalization by concentrated growth factorplatelet concentrate |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Healthy patients with immature permanent incisors
- Presence of clinical signs and symptoms of necrosis or chronic apical periodontitis. The chronic apical periodontitis signs and symptoms include little discomfort with intermittent episodes of pus discharge through the sinus tract.
Key exclusion criteria (5 listed)
- 1. Abnormal tooth mobility.
- Positive history of allergic reaction, systemic diseases, severe emotional or behavioral problems.
- Unrestorable teeth
- Abnormal tooth mobility
- Children with systemic, severe behavioral, or emotional problems
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 |
|---|---|---|
| revitalization by concentrated growth factorAlso: revitalization by platelet rich fibrinmodified platelet concentrate | Procedure or surgery | revitalization by concentrated growth factor, revitalization by platelet rich fibrin |
Primary outcome
Clinical success rate
Time frame: one year
Regaining tooth vitality with electric pulp testing Clinical examination includes pain absence, normal tooth mobility, and no sensitivity to percussion
Radiographic success using Periapical index (PAI)
Time frame: one year
Criteria of PAI scores: score "1" normal periapical structure score "2" small changes in bone structures score "3" changes in bone structure with some mineral loss score "4" periodontitis with well-defined radiolucent area score "5" severe periodontitis with exacerbating features
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2022.
- Individual participant dataSharing planned: Yes
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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.
Questions about this trial
What is this clinical trial studying?
A study testing revitalization by concentrated growth factor in people with Necrotic Pulp, run by Ahmad Elheeny.
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 2 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 31 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ghada tony, doctora (01117902713, ghadatony2003@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical success rate (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 Aug 2022.