RevascularizationNCT05147025
Evaluation of Retreatment of Failed Revasculatized Teeth by Revascularization
A study testing Revascularization in people with Revascularization, run by Minia University.
Trial summary
Study will include 30 participants with failed revascularized young permenant teeth that will be retreated by revascularization and evaluated for success through 2 years Read more about this study
- Who is it for?
- Ages 8 to 10 years
- Conditions the study is for
- Revascularization
- What is being tested?
- Revascularization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2021to 1 Jan 2024
- 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 8 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- central and lateral immature incisors
- child from 8- 10 years old
- healthy chidren
- failed revascularization
Who cannot join
- medically compromised children
- mentally compromised children
About this study
Official title: Evaluation of Retreatment of Failed Revasculatized Teeth by Revascularization. Randomized Clinical Trial
Study will include 30 participants with failed revascularized young permenant teeth that will be retreated by revascularization and evaluated for success through 2 years
- Conditions
- Revascularization
- Being tested
- Revascularization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RevascularizationOther
Regain pulp vascularity for young permenant teeth
| Study group | Role | What they receive |
|---|---|---|
| Revasularization | Experimental | Revascularization of failed previously revascularized younge permenant inciors Receives: Other: Revascularization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Root completion
Continue root maturation by radiographic assessment according to cvek classification ( increase root length)
Measured: 2 years
Increase dentine thickness
Increase dentine thickness as response to new formed pulp like tissues
Measured: 2 years
Lesion healing
Resolvation of periapical lesion through new bone formation, intact lamina dura, abscence of periapical radiolucency
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2021
- Study start1 Dec 2021 (estimated)
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RevascularizationStudies of the same condition, open and under way.
- More trials run by Minia UniversityThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Ahmed Mahmoud, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05147025
- Sponsor's protocol ID
- 801
- Status last verified
- Dec 2021
- First submitted
- 28 Oct 2021
- Last updated
- 7 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Retreatment of Failed Revasculatized Teeth by Revascularization. Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05147025
- Acronym / sponsor ID
- 801
- Conditions
- Revascularization
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 1 Dec 2021 (estimated)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Jan 2024 (estimated)
- First posted
- 7 Dec 2021 (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.
Study will include 30 participants with failed revascularized young permenant teeth that will be retreated by revascularization and evaluated for success through 2 years
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Revasularization | Experimental | Other: RevascularizationRevascularization of failed previously revascularized younge permenant inciors |
Who may qualify
- Ages
- 8 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- central and lateral immature incisors
- child from 8- 10 years old
- healthy chidren
- failed revascularization
Key exclusion criteria (2 listed)
- medically compromised children
- mentally compromised children
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 |
|---|---|---|
| RevascularizationRegain pulp vascularity for young permenant teeth | Other | Revasularization |
Primary outcome
Root completion
Time frame: 2 years
Continue root maturation by radiographic assessment according to cvek classification ( increase root length)
Increase dentine thickness
Time frame: 2 years
Increase dentine thickness as response to new formed pulp like tissues
Lesion healing
Time frame: 2 years
Resolvation of periapical lesion through new bone formation, intact lamina dura, abscence of periapical radiolucency
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Revascularization in people with Revascularization, run by Minia University.
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 4 inclusion and 2 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 7 Dec 2021. 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?
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?
Root completion (time frame: 2 years). The study lists 3 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 7 Dec 2021.