Immature Permanent Teeth With Open ApexNCT07802340
Efficiency of Asiaticoside as Intracanal Medication in Revascularization Process
A study testing Intracanal medication in people with Immature Permanent Teeth With Open Apex and Pulp Necrosis, run by Mansoura University at 1 site in Egypt.
Trial summary
This study assess the ability of Asiaticoside based Intracanal medication compared to the commonly used Intracanal medicament ( calcium hydroxide Ca(OH) 2) on the outcome of the revascularization process in immature permanent teeth with pulp necrosis Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Immature Permanent Teeth With Open Apex, Pulp Necrosis
- What is being tested?
- Intracanal medication
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2026to Feb 2028
- 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 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Both gender
- patients having permanent anterior teeth with necrotic pulp and immature apex
- Good general health
- pulp space not needed for post and core
Who cannot join
- Radiographic identification of root fracture or abnormality
- Uncooperative patients
- Root resorption (internal or external)
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
Mansoura University
Al Mansurah
Maha Baher Hassan, 01007987417, Mahabaher23@gmail.com
About this study
Official title: Efficiency of Asiaticoside as Intracanal Medication in Revascularization Process : Randomized Clinical Trial
This study assess the ability of Asiaticoside based Intracanal medication compared to the commonly used Intracanal medicament ( calcium hydroxide Ca(OH) 2) on the outcome of the revascularization process in immature permanent teeth with pulp necrosis
- Being tested
- Intracanal medication
- 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.
Intracanal medicationProcedure or surgery
Intracanal Medication for 3 weeks in Revascularization Process
| Study group | Role | What they receive |
|---|---|---|
| Asiaticoside | Experimental | Not described Receives: Procedure: Intracanal medication |
| Calcium hydroxide | Experimental | Not described Receives: Procedure: Intracanal medication |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase In Root Length
Radiographic increase in root length ( Millimeters(mm))
Measured: 12 monthsl
Increase In Dentinal Wall Thickness
Radiographic increase in dentinal wall thickness measured using digital image analysis (Millimeters(mm))
Measured: 12 months
Periapical Bone Formation
Radiographic evidence of periapical bone formation
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immature Permanent Teeth With Open ApexStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07802340
- Sponsor's protocol ID
- A01010024RC
- Status last verified
- Dec 2025
- First submitted
- 31 Aug 2026
- Last updated
- 23 Sep 2026
- 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 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficiency of Asiaticoside as Intracanal Medication in Revascularization Process : Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07802340
- Acronym / sponsor ID
- A01010024RC
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 3 Sep 2026 (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 assess the ability of Asiaticoside based Intracanal medication compared to the commonly used Intracanal medicament ( calcium hydroxide Ca(OH) 2) on the outcome of the revascularization process in immature permanent teeth with pulp necrosis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Asiaticoside | Experimental | Procedure: Intracanal medication |
| Calcium hydroxide | Experimental | Procedure: Intracanal medication |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Both gender
- patients having permanent anterior teeth with necrotic pulp and immature apex
- Good general health
- pulp space not needed for post and core
Key exclusion criteria (3 listed)
- Radiographic identification of root fracture or abnormality
- Uncooperative patients
- Root resorption (internal or external)
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 |
|---|---|---|
| Intracanal medicationIntracanal Medication for 3 weeks in Revascularization Process | Procedure or surgery | Asiaticoside, Calcium hydroxide |
Primary outcome
Increase In Root Length
Time frame: 12 monthsl
Radiographic increase in root length ( Millimeters(mm))
Increase In Dentinal Wall Thickness
Time frame: 12 months
Radiographic increase in dentinal wall thickness measured using digital image analysis (Millimeters(mm))
Periapical Bone Formation
Time frame: 12 months
Radiographic evidence of periapical bone formation
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 23 Sep 2026.
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Regenerative Root Canal Treatment of Immature Teeth Using Omega-3 Fatty Acids
Immature Permanent Teeth With Open Apex, Pulp Necrosis
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 Intracanal medication in people with Immature Permanent Teeth With Open Apex and Pulp Necrosis, run by Mansoura 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 4 inclusion and 3 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 23 Sep 2026. 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 Maha Baher Hassan (01007987417, Mahabaher23@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Increase In Root Length (time frame: 12 monthsl). 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 23 Sep 2026.