Non-vital Immature Anterior TeethNCT07252167
Comparison Between Emdogain and Amniotic Membrane as a Scaffold in Endodontic Regeneration of Immature Anterior Teeth
A study testing Regenerative endodontic treatment with conventional blood clot technique., regenerative endodontic treatment with emdogain. and regenerative endodontic treatment with amniotic membrane in people with Non-vital Immature Anterior Teeth, run by Al-Azhar University at 1 site in Egypt.
Trial summary
To evaluate the clinical outcomes and cone-beam computed tomography findings of enamel matrix derivative and amniotic membrane in regenerative endodontic treatment of non-vital immature permanent anterior teeth Read more about this study
- Who is it for?
- Ages 7 to 12 years
- Conditions the study is for
- Non-vital Immature Anterior Teeth
- What is being tested?
- Regenerative endodontic treatment with conventional blood clot technique., regenerative endodontic treatment with emdogain. and regenerative endodontic treatment with amniotic membrane
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2025to 1 Apr 2026
- 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 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- •Patients age ranges between 7 and 12 years at the time of enrolment including both genders. •Provision of informed consent by one parent or legal guardian. •At least one immature permanent anterior tooth diagnosed with pulp necrosis with or without periapical lesions. •Restorable teeth. •Compliant patient/parent. •Radiologic evidence of open apices (Teeth are considered immature when a minimum of 1 mm apical foramen width is evident)
Who cannot join
- •Teeth with root fractures or split roots. •Presence of root resorptions. •Presence of periodontal pockets. •Developmental anomalies. •Presence of periapical radiolucency of more than 10 mm. •Tooth with class III mobility.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparative Evaluation of Clinical Outcomes and Cone-Beam Computed Tomography Findings of Enamel Matrix Derivative and Amniotic Membrane in Regenerative Endodontic Treatment of Non Vital Immature Permanent Anterior Teeth: A Randomized Clinical Trial
To evaluate the clinical outcomes and cone-beam computed tomography findings of enamel matrix derivative and amniotic membrane in regenerative endodontic treatment of non-vital immature permanent anterior teeth
Read the detailed description
To evaluate the clinical outcomes and cone-beam computed tomography findings of enamel matrix derivative in comparison to amniotic membrane and MTA as a conventional group in regenerative endodontic treatment of non-vital immature permanent anterior teeth
- Conditions
- Non-vital Immature Anterior Teeth
- Being tested
- Regenerative endodontic treatment with conventional blood clot technique., regenerative endodontic treatment with emdogain., regenerative endodontic treatment with amniotic membrane
- Keywords
- Revascularization, endodontic regeneration, Immature
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regenerative endodontic treatment with conventional blood clot technique.Other
After local anesthesia, rubber dam isolation and access cavity preparation, pulp tissue extirpation/debridement, the root canal system is minimally instrumented. Copious irrigation is performed, gently with single-side vented needles. Canals are dried with paper points. Metapaste is injected as intracanal medication. At second session, check for absence of signs/symptoms. Copious gentle irrigation and drying of canals with paper points is done. Bleeding is created in root canal by over-instrumentation until bleeding is evident in the cervical portion of the canal. A lightly moistened sterile cotton pellet is placed into the canal, 3-4 mm apical to the CEJ, for 7-10 minutes to allow blood clot formation. Placement of MTA over the blood clot as a capping material. A 3-4 mm layer of glass ionomer is gently placed over the capping material. Followed by resin composite restoration.
regenerative endodontic treatment with emdogain.Other
- After local anesthesia, rubber dam isolation and access cavity preparation, pulp tissue extirpation/debridement, the root canal system is minimally instrumented. Copious irrigation is performed, gently with single-side vented needles. Canals are dried with paper points. Metapaste is injected as intracanal medication. At second session, check for absence of signs/symptoms. Copious gentle irrigation and drying of canals with paper points is done. Bleeding is created in root canal by over-instrumentation until bleeding is evident in the cervical portion of the canal. A lightly moistened sterile cotton pellet is placed into the canal, 3-4 mm apical to the CEJ, for 7-10 minutes to allow blood clot formation. Emdogain is injected inside the canal on the blood clot up to the CEJ to act as a matrix for the cells. Placement of MTA over the blood clot as a capping material. A 3-4 mm layer of glass ionomer is gently placed over the capping material. Followed by resin composite restoration.
regenerative endodontic treatment with amniotic membraneOther
- After local anesthesia, rubber dam isolation and access cavity preparation, pulp tissue extirpation/debridement, the root canal system is minimally instrumented. Copious irrigation is performed, gently with single-side vented needles. Canals are dried with paper points. Metapaste is injected as intracanal medication. At second session, check for absence of signs/symptoms. Copious gentle irrigation and drying of canals with paper points is done. Bleeding is created in root canal by over-instrumentation until bleeding is evident in the cervical portion of the canal. A lightly moistened sterile cotton pellet is placed into the canal, 3-4 mm apical to the CEJ, for 7-10 minutes to allow blood clot formation. Amniotic membrane will adapted inside the canal on the blood clot up to the CEJ. Placement of MTA over the blood clot as a capping material. A 3-4 mm layer of glass ionomer is gently placed over the capping material. Followed by resin composite restoration.
| Study group | Role | What they receive |
|---|---|---|
| Regenerative endodontic treatment using MTA | Experimental | Regenerative endodontic treatment with conventional blood clot technique. Receives: Other: Regenerative endodontic treatment with conventional blood clot technique. |
| Regenerative endodontic treatment using emdogain | Experimental | regenerative endodontic treatment with emdogain Receives: Other: regenerative endodontic treatment with emdogain. |
| Regenerative endodontic treatment using amniotic membrane | Other | regenerative endodontic treatment with amniotic membrane Receives: Other: regenerative endodontic treatment with amniotic membrane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic assessment of root length by CBCT
For all cases, CBCT was taken at a setting of 3-7 mA and 120 kVp and an exposure time of 9 s. Each scan was taken over 360º with a 0.3 mm voxel size. The root length was measured using the CBCT ruler to draw a line from the center point of the line connecting CEJ to the most apical point in the center of the root apex (proximally and facially). The percentage of increase in root length was calculated using this formula:
(12 months value - preoperative value )/Preoperative value X 100%
Measured: Baseline (immediately post-operative), an 12 months post-operative.
Radiographic assessment of diameter of apical foramen by CBCT
Diameter of the apical foramen was measured using the CBCT ruler at the most apical points buccolingually at the sagittal (proximal) view of CBCT. It was also measured at the most apical points mesiodistally at the coronal (facial) view of CBCT. The percentage reduction of the apical diameter was calculated using this formula:
( preoperative value - 12-month value ) /Preoperative value *100%
Measured: Baseline(immediately post-operative), and 12 months post-operative.
Radiographic assessment of root area by CBCT
Radiographic root area (RRA) was measured using a method described by Flake et al using the polygon selection tool of CBCT. Below a straight line marking the CEJ, the root area was outlined from the surrounding periodontal environment. Then, the pulp space area was measured by the same method using the polygon tool by tracing the reference points surrounding the pulp space. Finally, RRA was calculated by subtraction of the pulp space area from the outer root area. These measurements were made at proximal and facial views of CBCT . The percentage increase in RRA was calculated using this formula:
( 12-month value - preoperative value )/Preoperative value X 100 %
Measured: Baseline (immediately post-operative), and 12 months post-operative.
Radiographic assessment of size of periapical lesion by CBCT
Lesion size was measured by tracing the periphery of the lesion using the polygon tool of the CBCT from proximal and facial views of the CBCT. A closed polygon tool was used to delimit the border of the lesion to measure the area of the periapical lesion in (mm2).The percentage reduction of lesion size was calculated as follows:
( preoperative value - 12-month value ) /Preoperative value X 100 %
Measured: Baseline (Immediately post-operative), and 12 months post-operative.
Secondary outcomes (5)
Clinical assessment of presence/ absence of pain
Assessment of symptoms of patient whether there is a pain or not in each follow up period.
Measured: Baseline, 3 months, 6 months, and 12 months post operative.
Clinical assessment of presence/ absence of mobility of teeth
Assessment of teeth whether they exhibit mobility or not
Measured: Baseline, 3 months, 6 months, and 12 months post operative.
Clinical assessment of presence/ absence of associated sinus tract or swelling.
Assessment of teeth whether they exhibit associated sinus tract or swelling or not
Measured: Baseline, 3 months, 6 months, and 12 months post operative.
Clinical assessment of presence/ absence of tenderness to palpation of adjacent soft tissues.
Assessment of teeth whether they exhibit tenderness to palpation of adjacent soft tissues or not
Measured: Baseline, 3 months, 6 months, and 12 months post operative.
Clinical assessment of presence/ absence of tenderness to percussion
Assessment of teeth whether they exhibit tenderness to percussion
Measured: Baseline, 3 months, 6 months, and 12 months post operative.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2025
- Study start1 Mar 2025
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-vital Immature Anterior TeethStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abrar Hamed Habib Yousef, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07252167
- Sponsor's protocol ID
- Endodontic regeneration
- Status last verified
- Nov 2025
- First submitted
- 19 Nov 2025
- Last updated
- 26 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Evaluation of Clinical Outcomes and Cone-Beam Computed Tomography Findings of Enamel Matrix Derivative and Amniotic Membrane in Regenerative Endodontic Treatment of Non Vital Immature Permanent Anterior Teeth: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07252167
- Acronym / sponsor ID
- Endodontic regeneration
- Conditions
- Non-vital Immature Anterior Teeth
- Keywords
- Revascularization, endodontic regeneration, Immature
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 26 Nov 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.
To evaluate the clinical outcomes and cone-beam computed tomography findings of enamel matrix derivative and amniotic membrane in regenerative endodontic treatment of non-vital immature permanent anterior teeth
Detailed description
To evaluate the clinical outcomes and cone-beam computed tomography findings of enamel matrix derivative in comparison to amniotic membrane and MTA as a conventional group in regenerative endodontic treatment of non-vital immature permanent anterior teeth
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Regenerative endodontic treatment using MTA | Experimental | Other: Regenerative endodontic treatment with conventional blood clot technique.Regenerative endodontic treatment with conventional blood clot technique. |
| Regenerative endodontic treatment using emdogain | Experimental | Other: regenerative endodontic treatment with emdogain.regenerative endodontic treatment with emdogain |
| Regenerative endodontic treatment using amniotic membrane | Other | Other: regenerative endodontic treatment with amniotic membraneregenerative endodontic treatment with amniotic membrane |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- •Patients age ranges between 7 and 12 years at the time of enrolment including both genders. •Provision of informed consent by one parent or legal guardian. •At least one immature permanent anterior tooth diagnosed with pulp necrosis with or without periapical lesions. •Restorable teeth. •Compliant patient/parent. •Radiologic evidence of open apices (Teeth are considered immature when a minimum of 1 mm apical foramen width is evident)
Key exclusion criteria (1 listed)
- •Teeth with root fractures or split roots. •Presence of root resorptions. •Presence of periodontal pockets. •Developmental anomalies. •Presence of periapical radiolucency of more than 10 mm. •Tooth with class III mobility.
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 |
|---|---|---|
| Regenerative endodontic treatment with conventional blood clot technique.After local anesthesia, rubber dam isolation and access cavity preparation, pulp tissue extirpation/debridement, the root canal system is minimally instrumented. Copious irrigation is performed, gently with single-side vented needles. Canals are dried with paper points. Metapaste is injected as intracanal medication. At second session, check for absence of signs/symptoms. Copious gentle irrigation and drying of canals with paper points is done. Bleeding is created in root canal by over-instrumentation until bleeding is evident in the cervical portion of the canal. A lightly moistened sterile cotton pellet is placed into the canal, 3-4 mm apical to the CEJ, for 7-10 minutes to allow blood clot formation. Placement of MTA over the blood clot as a capping material. A 3-4 mm layer of glass ionomer is gently placed over the capping material. Followed by resin composite restoration. | Other | Regenerative endodontic treatment using MTA |
| regenerative endodontic treatment with emdogain.• After local anesthesia, rubber dam isolation and access cavity preparation, pulp tissue extirpation/debridement, the root canal system is minimally instrumented. Copious irrigation is performed, gently with single-side vented needles. Canals are dried with paper points. Metapaste is injected as intracanal medication. At second session, check for absence of signs/symptoms. Copious gentle irrigation and drying of canals with paper points is done. Bleeding is created in root canal by over-instrumentation until bleeding is evident in the cervical portion of the canal. A lightly moistened sterile cotton pellet is placed into the canal, 3-4 mm apical to the CEJ, for 7-10 minutes to allow blood clot formation. Emdogain is injected inside the canal on the blood clot up to the CEJ to act as a matrix for the cells. Placement of MTA over the blood clot as a capping material. A 3-4 mm layer of glass ionomer is gently placed over the capping material. Followed by resin composite restoration. | Other | Regenerative endodontic treatment using emdogain |
| regenerative endodontic treatment with amniotic membrane- After local anesthesia, rubber dam isolation and access cavity preparation, pulp tissue extirpation/debridement, the root canal system is minimally instrumented. Copious irrigation is performed, gently with single-side vented needles. Canals are dried with paper points. Metapaste is injected as intracanal medication. At second session, check for absence of signs/symptoms. Copious gentle irrigation and drying of canals with paper points is done. Bleeding is created in root canal by over-instrumentation until bleeding is evident in the cervical portion of the canal. A lightly moistened sterile cotton pellet is placed into the canal, 3-4 mm apical to the CEJ, for 7-10 minutes to allow blood clot formation. Amniotic membrane will adapted inside the canal on the blood clot up to the CEJ. Placement of MTA over the blood clot as a capping material. A 3-4 mm layer of glass ionomer is gently placed over the capping material. Followed by resin composite restoration. | Other | Regenerative endodontic treatment using amniotic membrane |
Primary outcome
Radiographic assessment of root length by CBCT
Time frame: Baseline (immediately post-operative), an 12 months post-operative.
For all cases, CBCT was taken at a setting of 3-7 mA and 120 kVp and an exposure time of 9 s. Each scan was taken over 360º with a 0.3 mm voxel size. The root length was measured using the CBCT ruler to draw a line from the center point of the line connecting CEJ to the most apical point in the center of the root apex (proximally and facially). The percentage of increase in root length was calculated using this formula: (12 months value - preoperative value )/Preoperative value X 100%
Radiographic assessment of diameter of apical foramen by CBCT
Time frame: Baseline(immediately post-operative), and 12 months post-operative.
Diameter of the apical foramen was measured using the CBCT ruler at the most apical points buccolingually at the sagittal (proximal) view of CBCT. It was also measured at the most apical points mesiodistally at the coronal (facial) view of CBCT. The percentage reduction of the apical diameter was calculated using this formula: ( preoperative value - 12-month value ) /Preoperative value *100%
Radiographic assessment of root area by CBCT
Time frame: Baseline (immediately post-operative), and 12 months post-operative.
Radiographic root area (RRA) was measured using a method described by Flake et al using the polygon selection tool of CBCT. Below a straight line marking the CEJ, the root area was outlined from the surrounding periodontal environment. Then, the pulp space area was measured by the same method using the polygon tool by tracing the reference points surrounding the pulp space. Finally, RRA was calculated by subtraction of the pulp space area from the outer root area. These measurements were made at proximal and facial views of CBCT . The percentage increase in RRA was calculated using this formula: ( 12-month value - preoperative value )/Preoperative value X 100 %
Radiographic assessment of size of periapical lesion by CBCT
Time frame: Baseline (Immediately post-operative), and 12 months post-operative.
Lesion size was measured by tracing the periphery of the lesion using the polygon tool of the CBCT from proximal and facial views of the CBCT. A closed polygon tool was used to delimit the border of the lesion to measure the area of the periapical lesion in (mm2).The percentage reduction of lesion size was calculated as follows: ( preoperative value - 12-month value ) /Preoperative value X 100 %
5 secondary outcomes
Clinical assessment of presence/ absence of pain
Time frame: Baseline, 3 months, 6 months, and 12 months post operative.
Clinical assessment of presence/ absence of mobility of teeth
Time frame: Baseline, 3 months, 6 months, and 12 months post operative.
Clinical assessment of presence/ absence of associated sinus tract or swelling.
Time frame: Baseline, 3 months, 6 months, and 12 months post operative.
Clinical assessment of presence/ absence of tenderness to palpation of adjacent soft tissues.
Time frame: Baseline, 3 months, 6 months, and 12 months post operative.
Clinical assessment of presence/ absence of tenderness to percussion
Time frame: Baseline, 3 months, 6 months, and 12 months post operative.
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 26 Nov 2025.
- Individual participant dataSharing planned: Yes
Related trials for Non-vital Immature Anterior Teeth
Not yet recruitingPhase 2
Clinical and Radio-graphic Evaluation of Non-staining Bio-active Bio-ceramic (Neo MTA 2) in Revascularization
Mineral Trioxide Aggregate
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 study testing Regenerative endodontic treatment with conventional blood clot technique., regenerative endodontic treatment with emdogain. and regenerative endodontic treatment with amniotic membrane in people with Non-vital Immature Anterior Teeth, run by Al-Azhar 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 1 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 26 Nov 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?
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?
Radiographic assessment of root length by CBCT (time frame: Baseline (immediately post-operative), an 12 months post-operative.). The study lists 4 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 26 Nov 2025.