Pulpal NecrosisNCT07210359
Evaluation of Regenerative Endodontic Treatment for Immature Teeth
A study testing human treated dentin matrix hydrogel, Theracal LC - Demineralized dentin matrix combination and Retro Mta in people with Pulpal Necrosis, run by Kafrelsheikh University at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to evaluate if regenerative endodontic treatment using two different forms of demineralized dentin matrix (DDM) can effectively treat immature permanent single-rooted teeth compared to treatment using RetroMTA in patients aged 9 to 15 years. Read more about this study
- Who is it for?
- Ages 9 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulpal Necrosis
- What is being tested?
- human treated dentin matrix hydrogel, Theracal LC - Demineralized dentin matrix combination and Retro Mta
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Sep 2025to Dec 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 9 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Systemically healthy patients (i.e., free of any systemic diseases).
- Patients presenting with immature permanent single-rooted teeth.
- Age: 9 -15 years.
- Teeth diagnosed as either vital (asymptomatic irreversible pulpitis or symptomatic irreversible pulpitis and the bleeding didn't stop after 5 minutes application of hemostatic agent) or non-vital pulp.
Who cannot join
- Patients who are allergic to any drugs used in this study or with systemic illness
- Teeth that are grossly decayed or fractured and require post and core as final restorations
- Presence of periodontal pockets greater than 4 mm.
- Radiographical evidence of apical foramen less than 1 mm.
- Presence of periapical radiolucency exceeding 10 mm.
- Presence of external or internal root resorption.
- Patients with a history of major surgeries like cardiac, kidney transplantation, haemodialysis.
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
KafrelsheikhU
Kafr ash Shaykh, Kafr Elsheikh, 33511
Dina Abdullah, 01226083903, dr.dinaabdullah954@gmail.com
Hisham Abada, 01003772427, hishamdentist@gmail.com
About this study
Official title: Evaluation of Regenerative Endodontic Treatment for Immature Teeth Using Two Different Forms of Demineralized Dentin Matrix and RetroMTA: Randomized Controlled Clinical Trial
The goal of this clinical trial is to evaluate if regenerative endodontic treatment using two different forms of demineralized dentin matrix (DDM) can effectively treat immature permanent single-rooted teeth compared to treatment using RetroMTA in patients aged 9 to 15 years. The main questions it aims to answer are:
Does the use of DDM improve clinical and radiographic outcomes such as root length, dentinal wall thickness, and apex closure?
Read more
Is DDM a viable bioactive alternative to RetroMTA as a coronal sealing material in regenerative endodontic procedures?
Researchers will compare three groups: one using RetroMTA, one using a DDM-TheraCal LC mixture, and one using TDM-Hydrogel, to see if these materials differ in their effects on regenerative outcomes.
Participants will:
Undergo two treatment visits including canal disinfection, induction of bleeding to form a blood clot scaffold,
Receive placement of one of the study materials over the blood clot as a coronal barrier,
Have clinical examinations and CBCT imaging at baseline and multiple follow-ups up to 12 months to assess treatment success through signs, symptoms, and radiographic changes.
Read the detailed description
The study was conducted as a split-mouth randomized clinical trial, approved by research ethics committee, Faculty of Dentistry, Kafrelsheikh University, and carried out at Endodontic Department, Faculty of Dentistry, Kafrelsheikh University. 36 patients of both sexes aged from 9 to 15 years old were selected with an immature teeth with teeth diagnosed as either vital (asymptomatic irreversible pulpitis or symptomatic irreversible pulpitis and the bleeding didn't stop after 5 minutes application of hemostatic agent) or non-vital pulp are indicated for regenerative endodontic procedure.
Patients will be divided randomly into three equal groups (n = 12):
Group 1(control group): Revascularization will be done using blood clot and RetroMTA as coronal barrier.
Group 2: Revascularization will be done using blood clot and DDM-TheraCal LC mixture paste as coronal barrier.
Group 3: Revascularization will be done using blood clot and TDM-Hydrogel as coronal barrier.
CBCT image will be obtained for baseline records before treatment and after placement of the final resin restoration, then the patients will be recalled after 3, 6, 9 and 12 months for evaluating any changes in dentin bridge formation, root length, root canal width, apex diameter and lesion size if present.
- Conditions
- Pulpal Necrosis
- Being tested
- human treated dentin matrix hydrogel, Theracal LC - Demineralized dentin matrix combination, Retro Mta
- 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.
human treated dentin matrix hydrogelProcedure or surgery
Also called demineralized dentin matrix
material used for regenerative dentistry
Theracal LC - Demineralized dentin matrix combinationProcedure or surgery
material used for regenerative dentistry
Retro MtaProcedure or surgery
material used for regenerative dentistry
| Study group | Role | What they receive |
|---|---|---|
| treated hyman dentin matrix hydrogel | Active comparator | material used for regenerative dentistry Receives: Procedure: Theracal LC - Demineralized dentin matrix combination; Procedure: Retro Mta |
| Theracal LC- Demineralized dentina matrix combination | Active comparator | material used for regenerative dentistry Receives: Procedure: human treated dentin matrix hydrogel; Procedure: Retro Mta |
| RetroMTA | Active comparator | material used for regenerative dentistry Receives: Procedure: human treated dentin matrix hydrogel; Procedure: Theracal LC - Demineralized dentin matrix combination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maturation of root
root length increase, root width increase, apical formane closes and dentinal bridge formation over regenerated pulp
Measured: year
Secondary outcomes (1)
resolve of apical lesion if present
if there is any apical lesion, it will resolve and new bone formation takes place.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2025
- Study start15 Sep 2025
- Primary completion20 Sep 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulpal NecrosisStudies of the same condition, open and under way.
- More trials run by Kafrelsheikh 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
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hisham Mahmoud Hamdy Abada, Kafrelsheikh University
- Investigators
- Hisham Abada, Doctors, Principal investigator, Academic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07210359
- Sponsor's protocol ID
- 663
- Status last verified
- Sep 2025
- First submitted
- 29 Sep 2025
- Last updated
- 7 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Regenerative Endodontic Treatment for Immature Teeth Using Two Different Forms of Demineralized Dentin Matrix and RetroMTA: Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07210359
- Acronym / sponsor ID
- 663
- Conditions
- Pulpal Necrosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 15 Sep 2025 (actual)
- Primary completion
- 20 Sep 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 7 Oct 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 goal of this clinical trial is to evaluate if regenerative endodontic treatment using two different forms of demineralized dentin matrix (DDM) can effectively treat immature permanent single-rooted teeth compared to treatment using RetroMTA in patients aged 9 to 15 years. The main questions it aims to answer are:
Does the use of DDM improve clinical and radiographic outcomes such as root length, dentinal wall thickness, and apex closure?
Is DDM a viable bioactive alternative to RetroMTA as a coronal sealing material in regenerative endodontic procedures?
Researchers will compare three groups: one using RetroMTA, one using a DDM-TheraCal LC mixture, and one using TDM-Hydrogel, to see if these materials differ in their effects on regenerative outcomes.
Participants will:
Undergo two treatment visits including canal disinfection, induction of bleeding to form a blood clot scaffold,
Receive placement of one of the study materials over the blood clot as a coronal barrier,
Have clinical examinations and CBCT imaging at baseline and multiple follow-ups up to 12 months to assess treatment success through signs, symptoms, and radiographic changes.
Detailed description
The study was conducted as a split-mouth randomized clinical trial, approved by research ethics committee, Faculty of Dentistry, Kafrelsheikh University, and carried out at Endodontic Department, Faculty of Dentistry, Kafrelsheikh University. 36 patients of both sexes aged from 9 to 15 years old were selected with an immature teeth with teeth diagnosed as either vital (asymptomatic irreversible pulpitis or symptomatic irreversible pulpitis and the bleeding didn't stop after 5 minutes application of hemostatic agent) or non-vital pulp are indicated for regenerative endodontic procedure.
Patients will be divided randomly into three equal groups (n = 12):
Group 1(control group): Revascularization will be done using blood clot and RetroMTA as coronal barrier.
Group 2: Revascularization will be done using blood clot and DDM-TheraCal LC mixture paste as coronal barrier.
Group 3: Revascularization will be done using blood clot and TDM-Hydrogel as coronal barrier.
CBCT image will be obtained for baseline records before treatment and after placement of the final resin restoration, then the patients will be recalled after 3, 6, 9 and 12 months for evaluating any changes in dentin bridge formation, root length, root canal width, apex diameter and lesion size if present.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| treated hyman dentin matrix hydrogel | Active comparator | Procedure: Theracal LC - Demineralized dentin matrix combination, Procedure: Retro Mtamaterial used for regenerative dentistry |
| Theracal LC- Demineralized dentina matrix combination | Active comparator | Procedure: human treated dentin matrix hydrogel, Procedure: Retro Mtamaterial used for regenerative dentistry |
| RetroMTA | Active comparator | Procedure: human treated dentin matrix hydrogel, Procedure: Theracal LC - Demineralized dentin matrix combinationmaterial used for regenerative dentistry |
Who may qualify
- Ages
- 9 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Systemically healthy patients (i.e., free of any systemic diseases).
- Patients presenting with immature permanent single-rooted teeth.
- Age: 9 -15 years.
- Teeth diagnosed as either vital (asymptomatic irreversible pulpitis or symptomatic irreversible pulpitis and the bleeding didn't stop after 5 minutes application of hemostatic agent) or non-vital pulp.
Key exclusion criteria (7 listed)
- Patients who are allergic to any drugs used in this study or with systemic illness
- Teeth that are grossly decayed or fractured and require post and core as final restorations
- Presence of periodontal pockets greater than 4 mm.
- Radiographical evidence of apical foramen less than 1 mm.
- Presence of periapical radiolucency exceeding 10 mm.
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 |
|---|---|---|
| human treated dentin matrix hydrogelAlso: demineralized dentin matrixmaterial used for regenerative dentistry | Procedure or surgery | RetroMTA, Theracal LC- Demineralized dentina matrix combination |
| Theracal LC - Demineralized dentin matrix combinationmaterial used for regenerative dentistry | Procedure or surgery | RetroMTA, treated hyman dentin matrix hydrogel |
| Retro Mtamaterial used for regenerative dentistry | Procedure or surgery | Theracal LC- Demineralized dentina matrix combination, treated hyman dentin matrix hydrogel |
Primary outcome
Maturation of root
Time frame: year
root length increase, root width increase, apical formane closes and dentinal bridge formation over regenerated pulp
1 secondary outcome
resolve of apical lesion if present
Time frame: 1 year
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 7 Oct 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Pulpal Necrosis
Not yet recruiting
Post-operative Pain and Clinical Outcome After Single-cone Obturation With a Calcium Silicate-based Versus Epoxy Resin Sealer
Post Operative Pain, Acute, Irreversible Pulpitis (Toothache)
Not yet recruiting
PRP-Assisted Regenerative Endodontics Versus Conventional Root Canal Treatment in Mature Necrotic Teeth
Pulp Necrosis, Apical Periodontitis
Not yet recruiting
Clinical and Inflammatory Outcomes of Regenerative Endodontic Treatment Using Injectable Platelet-Rich Fibrin in Mature Necrotic Teeth With Chronic Apical Periodontitis.
Chronic Apical Periodontitis, Pulp Necrosis
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Conventional and Nano-Metronidazole Irrigation With/Without Activation in Necrotic Teeth With Apical Periodontitis
Pulp Necrosis, Apical Periodontitis
Not yet recruiting
The Effect of Bitewing Radiography on Outcomes and Costs of Treating Caries in Permanent Teeth
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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.
Hisham Abada, Doctors principal investigator
Academic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing human treated dentin matrix hydrogel, Theracal LC - Demineralized dentin matrix combination and Retro Mta in people with Pulpal Necrosis, run by Kafrelsheikh 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 7 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 7 Oct 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 Dina Sarhan, Masters (01226083903, dr.dinaabdullah954@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maturation of root (time frame: year). 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 7 Oct 2025.