Randomized Clinical TrialPhase 1NCT06812351
Clinical and Radiographic Outcome of Regeneration in Immature Permanent Human Teeth Using a New Scaffold
A Phase 1 study testing Osteon III collagen and Blood clot in people with Randomized Clinical Trial, run by Ain Shams University at 1 site in Egypt.
Trial summary
This study aimed to evaluate clinical and radiographic outcome of regeneration in immature permanent human teeth using two different types of scaffolds: 1. Collagen-hydroxyapatite scaffold (Osteon III collagen) after blood clot. 2. Conventional blood clot scaffold. Read more about this study
- Who is it for?
- Ages 6 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Randomized Clinical Trial
- What is being tested?
- Osteon III collagen and Blood clot
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteEgypt
- Study dates
- 22 Mar 2020to 22 Mar 2022
- Phase
- Phase 1
- 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 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Single rooted immature permanent teeth.
- Symptoms:
- Pulp necrosis either due to infection or trauma.
- Periapical condition; tooth should have periapical radiolucency.
- Tooth should be restorable without the need for further post placement.
- Age: from 6-15 years.
- Sex: males or females.
- Preoperative Cone beam Computed tomography is a must.
Who cannot join
- Teeth with complete root formation. 2. Teeth that are badly broken down with difficult isolation. 3. Medically compromised patients. 4. Periodontally affected teeth.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical and Radiographic Outcome of Regenerative Endodontic Treatment in Immature Permanent Human Teeth Using a Collagen Hydroxyapatite Scaffold
This study aimed to evaluate clinical and radiographic outcome of regeneration in immature permanent human teeth using two different types of scaffolds:
- Collagen-hydroxyapatite scaffold (Osteon III collagen) after blood clot.
- Conventional blood clot scaffold.
- Conditions
- Randomized Clinical Trial
- Being tested
- Osteon III collagen, Blood clot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osteon III collagenDrug
Also called Double antibiotic liquid
Hydroxyapatite and tricalcium phosphate particles embeded in bovine collagen
Blood clotBiological
Induction of bleeding from apical papilla
| Study group | Role | What they receive |
|---|---|---|
| Scaffold with blood clot group | Experimental | root canals were filled with Osteon III Collagen scaffold after blood clot induction during revascularization. Receives: Drug: Osteon III collagen |
| blood clot group | Placebo comparator | root canals were filled with blood clot only after conventional revascularization procedure. Receives: Biological: Blood clot |
What is being measured
The primary outcome is the main question the study is designed to answer.
Root completion of immature teeth
Root completion of immature teeth will be measured in terms of increase in root length, dentin thickness and apical foramen closure
Measured: 1 year follow up
Secondary outcomes (1)
positive sensibility test
Measured: 1 year follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2025
- Study start22 Mar 2020
- Primary completion22 Mar 2021
- Study completion22 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Randomized Clinical TrialStudies of the same condition, open and under way.
- More trials run by Ain Shams 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Menna Ali, Ain Shams University
- Investigators
- Abeer Abdelhakim El gendy, PhD, Study director, AinShams UniversityMaram Farouk Obeid, PhD, Study director, AinShams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06812351
- Sponsor's protocol ID
- RCT1
- Status last verified
- Feb 2025
- First submitted
- 1 Dec 2024
- Last updated
- 6 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Outcome of Regenerative Endodontic Treatment in Immature Permanent Human Teeth Using a Collagen Hydroxyapatite Scaffold
- ClinicalTrials.gov ID
- NCT06812351
- Acronym / sponsor ID
- RCT1
- Conditions
- Randomized Clinical Trial
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 22 Mar 2020 (actual)
- Primary completion
- 22 Mar 2021 (actual)
- Study completion
- 22 Mar 2022 (actual)
- First posted
- 6 Feb 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.
This study aimed to evaluate clinical and radiographic outcome of regeneration in immature permanent human teeth using two different types of scaffolds:
- Collagen-hydroxyapatite scaffold (Osteon III collagen) after blood clot.
- Conventional blood clot scaffold.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Scaffold with blood clot group | Experimental | Drug: Osteon III collagenroot canals were filled with Osteon III Collagen scaffold after blood clot induction during revascularization. |
| blood clot group | Placebo comparator | Biological: Blood clotroot canals were filled with blood clot only after conventional revascularization procedure. |
Who may qualify
- Ages
- 6 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Single rooted immature permanent teeth.
- Symptoms:
- Tooth should be restorable without the need for further post placement.
- Age: from 6-15 years.
- Sex: males or females.
Key exclusion criteria (1 listed)
- Teeth with complete root formation. 2. Teeth that are badly broken down with difficult isolation. 3. Medically compromised patients. 4. Periodontally affected teeth.
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 |
|---|---|---|
| Osteon III collagenAlso: Double antibiotic liquidHydroxyapatite and tricalcium phosphate particles embeded in bovine collagen | Drug | Scaffold with blood clot group |
| Blood clotInduction of bleeding from apical papilla | Biological | blood clot group |
Primary outcome
Root completion of immature teeth
Time frame: 1 year follow up
Root completion of immature teeth will be measured in terms of increase in root length, dentin thickness and apical foramen closure
1 secondary outcome
positive sensibility test
Time frame: 1 year follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2025.
- Individual participant dataSharing planned: No
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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.
Abeer Abdelhakim El gendy, PhD study director
AinShams University
Maram Farouk Obeid, PhD study director
AinShams University
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 Osteon III collagen and Blood clot in people with Randomized Clinical Trial, run by Ain Shams 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 8 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: finished, as of the sponsor's last update on 6 Feb 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 of immature teeth (time frame: 1 year follow up). 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 6 Feb 2025.