AvulsionPhase 1(EIRR)NCT06785961
Healing Assessment of External Inflammatory Root Resorption After Revascularization Technique of Avulsed Permanent Central Incisor (Case Study)
A Phase 1 study testing Regeneration of traumatic tooth in people with Avulsion, run by Badr University at 1 site in Egypt.
Trial summary
Evaluate the healing of external root resorption of replanted avulsed permanent maxillary central incisor after revascularization. Read more about this study
- Who is it for?
- Ages 11 months and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Avulsion
- What is being tested?
- Regeneration of traumatic tooth
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteEgypt
- Study dates
- 27 Nov 2024to 31 Aug 2025
- Phase
- Phase 1
- 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 11 months and older
- Men only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- traumatic teeth
- external inflammatory root resorption
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Evaluate the healing of external root resorption of replanted avulsed permanent maxillary central incisor after revascularization.
Read the detailed description
Healing assessment of external inflammatory Root Resorption after Revascularization Technique of Avulsed permanent Central Incisor (Case study)
- Conditions
- Avulsion
- Being tested
- Regeneration of traumatic tooth
- Medical subject headings
- Fractures, Avulsion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regeneration of traumatic toothProcedure or surgery
Revascularization is a new treatment method for immature necrotic , pulp revascularization allows also the stimulation of the apical development and the root maturation of immature teeth ( growth and thickening of dentinal walls ).
| Study group | Role | What they receive |
|---|---|---|
| Single- arm | Experimental | Case study Receives: Procedure: Regeneration of traumatic tooth |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure amount of bone healing and root formation by using cone beam computed tomography (CBCT)
Measure amount of bone healing and root formation by using measuring tool cone beam computed tomography (CBCT) By using measuring unit hounsfield unit (HU)
Measured: 18 months
Secondary outcomes (2)
Measuring pain by using the numeric pain rating scale
Measuring pain by using the numeric pain rating scale, through patient is asked to make three pain rating, the average of three ratings was used to represent the patient's level of pain (0 none) (1-3 mild) (4-6 moderate) (7-10 severe)
Measured: 18 months
Pulp test to assess the vitality or health of the dental pulp
Pulp test to assess the vitality or health of the dental pulp through measuring tool thermal pulp test :applied to the tooth to assess the response. The unit of measurement here is typically °C (degrees Celsius) .
Measured: Every 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2025
- Study start27 Nov 2024
- Primary completion31 Aug 2025 (estimated)
- Study completion31 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AvulsionStudies 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Badr University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelrhaman Reda Elshair, Badr University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06785961
- Sponsor's protocol ID
- BUC-IACUC-241020-113
- Acronym
- (EIRR)
- Status last verified
- Jan 2025
- First submitted
- 8 Dec 2024
- Last updated
- 21 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healing Assessment of External Inflammatory Root Resorption After Revascularization Technique of Avulsed Permanent Central Incisor (Case Study)
- ClinicalTrials.gov ID
- NCT06785961
- Acronym / sponsor ID
- (EIRR) / BUC-IACUC-241020-113
- Conditions
- Avulsion
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Badr UniversityUniversity, hospital or other
- Study start
- 27 Nov 2024 (actual)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 21 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.
Evaluate the healing of external root resorption of replanted avulsed permanent maxillary central incisor after revascularization.
Detailed description
Healing assessment of external inflammatory Root Resorption after Revascularization Technique of Avulsed permanent Central Incisor (Case study)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single- arm | Experimental | Procedure: Regeneration of traumatic toothCase study |
Who may qualify
- Ages
- 11 months and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- traumatic teeth
- external inflammatory root resorption
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Regeneration of traumatic toothRevascularization is a new treatment method for immature necrotic , pulp revascularization allows also the stimulation of the apical development and the root maturation of immature teeth ( growth and thickening of dentinal walls ). | Procedure or surgery | Single- arm |
Primary outcome
Measure amount of bone healing and root formation by using cone beam computed tomography (CBCT)
Time frame: 18 months
Measure amount of bone healing and root formation by using measuring tool cone beam computed tomography (CBCT) By using measuring unit hounsfield unit (HU)
2 secondary outcomes
Measuring pain by using the numeric pain rating scale
Time frame: 18 months
Pulp test to assess the vitality or health of the dental pulp
Time frame: Every 6 months
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 21 Jan 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Regeneration of traumatic tooth in people with Avulsion, run by Badr 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 2 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 21 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.
What does this 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.
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?
Measure amount of bone healing and root formation by using cone beam computed tomography (CBCT) (time frame: 18 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 21 Jan 2025.