Necrotic Immature Permanent IncisorsNCT06762821
A 24-month Outcomes of Single- Vs Multiple-visit Revascularization
A study testing Single-visit revascularization and Multiple-visit revascularization in people with Necrotic Immature Permanent Incisors, run by Minia University at 1 site in Egypt.
Trial summary
The current randomized clinical trial will be conducted to evaluate the 24-month clinical and radiographic outcomes after revascularization of asymptomatic necrotic immature permanent maxillary incisors using single- or multiple-visit protocol. Read more about this study
- Who is it for?
- Ages 7 to 13 years
- Conditions the study is for
- Necrotic Immature Permanent Incisors
- What is being tested?
- Single-visit revascularization and Multiple-visit revascularization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteEgypt
- Study dates
- 21 Dec 2024to Mar 2027
- Phase
- Interventional
- 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 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Compliant healthy patients who had at least one immature maxillary permanent incisor requiring nonsurgical root canal treatment.
- Patients presenting with a diagnosis of pulp necrosis with chronic apical periodontitis confirmed by history, clinical, radiographic and operative examination.
- Patient without previous endodontic treatment in affected tooth.
Who cannot join
- Patients with systemic conditions (medical, developmental or behavioral) that make routine dental treatment difficult.
- Patients taking medications that can interfere with healing or hemostasis.
- Patients with allergy to local anesthetics
- Children who will not comply to recall program.
- Teeth with extensive loss of coronal tissue that require restoration with a post
- Teeth with internal or external root resorption
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Minia University Dental Hospita
Minya
Faculty of Dentistry, Minia University, 0020159939498
About this study
Official title: Clinical and Radiographic Outcomes of Single- Versus Multiple-visit Revascularization of Asymptomatic Necrotic Immature Maxillary Permanent Incisors: a 24-month Randomized Clinical Trial
The current randomized clinical trial will be conducted to evaluate the 24-month clinical and radiographic outcomes after revascularization of asymptomatic necrotic immature permanent maxillary incisors using single- or multiple-visit protocol.
- Conditions
- Necrotic Immature Permanent Incisors
- Being tested
- Single-visit revascularization, Multiple-visit revascularization
- Keywords
- single-visit
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single-visit revascularizationProcedure or surgery
Revascularization protocol will be performed in single visit
Multiple-visit revascularizationProcedure or surgery
Revascularization protocol will be performed in multiple visit
| Study group | Role | What they receive |
|---|---|---|
| Single-visit revascularization | Experimental | Revascularization protocol will be performed in single visit Receives: Procedure: Single-visit revascularization |
| multiple-visit revascularization | Active comparator | Revascularization protocol will be performed in multiple visits Receives: Procedure: Multiple-visit revascularization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants experiencing Pain after treatment
Zero is equivalent to no pain and 1 indicates presence of pain that necessitate taking pain killer
Measured: From enrollment to the end of treatment at 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2025
- Study start21 Dec 2024
- Primary completionMar 2025 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Necrotic Immature Permanent IncisorsStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Osama Seif El-Nasr Hussein Gad El-Hak, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06762821
- Sponsor's protocol ID
- 20241220284
- Status last verified
- Dec 2024
- First submitted
- 23 Dec 2024
- Last updated
- 8 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Ethical Considerations
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Outcomes of Single- Versus Multiple-visit Revascularization of Asymptomatic Necrotic Immature Maxillary Permanent Incisors: a 24-month Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06762821
- Acronym / sponsor ID
- 20241220284
- Conditions
- Necrotic Immature Permanent Incisors
- Keywords
- single-visit
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 21 Dec 2024 (actual)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 8 Jan 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.
The current randomized clinical trial will be conducted to evaluate the 24-month clinical and radiographic outcomes after revascularization of asymptomatic necrotic immature permanent maxillary incisors using single- or multiple-visit protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single-visit revascularization | Experimental | Procedure: Single-visit revascularizationRevascularization protocol will be performed in single visit |
| multiple-visit revascularization | Active comparator | Procedure: Multiple-visit revascularizationRevascularization protocol will be performed in multiple visits |
Who may qualify
- Ages
- 7 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Compliant healthy patients who had at least one immature maxillary permanent incisor requiring nonsurgical root canal treatment.
- Patients presenting with a diagnosis of pulp necrosis with chronic apical periodontitis confirmed by history, clinical, radiographic and operative examination.
- Patient without previous endodontic treatment in affected tooth.
Key exclusion criteria (6 listed)
- Patients with systemic conditions (medical, developmental or behavioral) that make routine dental treatment difficult.
- Patients taking medications that can interfere with healing or hemostasis.
- Patients with allergy to local anesthetics
- Children who will not comply to recall program.
- Teeth with extensive loss of coronal tissue that require restoration with a post
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 |
|---|---|---|
| Single-visit revascularizationRevascularization protocol will be performed in single visit | Procedure or surgery | Single-visit revascularization |
| Multiple-visit revascularizationRevascularization protocol will be performed in multiple visit | Procedure or surgery | multiple-visit revascularization |
Primary outcome
Number of Participants experiencing Pain after treatment
Time frame: From enrollment to the end of treatment at 24 months
Zero is equivalent to no pain and 1 indicates presence of pain that necessitate taking pain killer
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 8 Jan 2025.
- Individual participant dataSharing planned: No. Ethical Considerations
Related trials for Necrotic Immature Permanent Incisors
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Necrotic Immature Permanent Incisors
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single-visit revascularization and Multiple-visit revascularization in people with Necrotic Immature Permanent Incisors, run by Minia University 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 3 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 8 Jan 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.
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?
Contact Gad El-Hak, Lecturer (00201023449797, osama.seif@mu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants experiencing Pain after treatment (time frame: From enrollment to the end of treatment at 24 months). 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 8 Jan 2025.