Dental TraumaNCT06006052
Regenerative Endodontic in Immature Permanent Teeth
A study testing regeneration technique in people with Dental Trauma, run by Ain Shams University at 1 site in Egypt.
Trial summary
Compare the clinical and radiographic outcomes of demineralized dentin matrix scaffold to blood clot scaffold in immature permanent incisors with non-vital pulps for one year (in vivo). Investigate the effect of demineralized dentin matrix (DDM) on dental pulp stem cells (DPSCs) (in vitro). Read more about this study
- Who is it for?
- Ages 7 to 13 years
- Conditions the study is for
- Dental Trauma
- What is being tested?
- regeneration technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2022to 1 Jul 2024
- Phase
- Interventional
- 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 7 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
None listed.
Who cannot join
- the patients will excluded if one of the following criteria is present in the patients
- Teeth with root fractures.
- Presence of internal or external root resorptions.
- Developmental anomalies of the root.
- Presence of periapical radiolucency more than 10 mm.
- Tooth with class III mobility.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ain shams university
Cairo, Alabbassia, 11566
marwa abozed, 00201142621411, marwaabozed@dent.asu.edu.eg
mariem wassel, 00201064871416, mariem.wassel@dent.asu.edu.eg
About this study
Official title: Evaluation of Demineralized Dentin Matrix as a Scaffold for Revascularization in Immature Permanent Incisors: A Randomized Controlled Trial and an In -Vitro Study
Compare the clinical and radiographic outcomes of demineralized dentin matrix scaffold to blood clot scaffold in immature permanent incisors with non-vital pulps for one year (in vivo).
Investigate the effect of demineralized dentin matrix (DDM) on dental pulp stem cells (DPSCs) (in vitro).
Read the detailed description
Necrosis of the immature pulp not only is one of the multiple factors affecting long-term tooth endurance and preservation but also can act as a source of bacterial infection in the periapical area and even the maxillofacial spaces
- The use of regenerative endodontic techniques (RET) have gained popularity in the past decade with several endodontic and pediatric dentistry organization recognizing this technique as a viable technique for immature permanent teeth with necrotic pulps Regenerative endodontics are defined as biologically based techniques planned to physiologically replace impaired tooth structure, including dentin and root constructions, as well as cells of the pulp-dentin complex
- They offer the benefit of root lengthening, thickening, and subsequent apical closure which is not achievable with conventional nonsurgical endodontic treatment (NSET). The success rate of the blood clot (RET) in immature teeth has been reported to be 97.8% .The American Association of Endodontists and the European Society of Endodontology developed evidence-based protocols. To help reduce some of the differences in the RET steps such as EDTA ethylene diamine tetra acetic acid and sodium hypochlorite use, however, variations in terms of intracanal medicament, scaffold, and assessment tools still exist due to the lack of high-quality evidence
A fundamental component of the regenerative endodontic process is the presence of a scaffold for stem cells from the apical papilla to adhere, multiply and differentiate. Based on the results of many studies, the use of blood clot Regenerative procedure is not considered a true scaffold system. But it is an essential part of any appropriately designed tissue engineering regenerative endodontic strategy
.
Different treatment options and scaffolds have been tested in regenerative endodontics. Only
some of them exhibited clinical relevance such as blood clot, platelet-rich plasma, and platelet- rich fibrin as RET scaffolds. Therefore, the use of a suitable scaffold is an essential part of tissue
engineering regenerative endodontic strategy .
Hence, developing a new dental material that retains the proteins or factors that can stimulate regenerative processes close to the natural process seems promising . Tissue-derived extracellular matrices have recently been known as naturally-derived scaffolds for tissue regeneration in various applications and have been revealed to serve as a cultural substrate on which cells tend to adhere to and proliferate well and can induce regeneration specific to tissues and sites
A new extracellular matrix material, demineralized dentin matrix (DDM) derived from extracted teeth has been found to act as a biocompatible scaffold for the attachment, differentiation, and proliferation of human DPSCs (dental pulp stem cell) into odontoblast-like cells . The dentin matrix has proposed roles for directing mineralized tissue repair in dentine and bone; however, the range of bioactive components in dentine and specific biological effects on bone-derived mesenchymal stem cells (MSCs) in humans are less well understood
.
DDM is an autogenous tooth dentin that has osteoconductive and osteoinductive potential since it contains extracellular collagen-1 and various growth factors. DDM as a solid blocky material has less physical stability and sealing ability as a material for regenerative endodontics.
Therefore it has been further fabricated into the forms of DDM powder, gel, and sheets to maintain bioactivity .
DDM can be prepared with low risks of infection and rejection with noninvasive attainability; thus, it should be considered a natural resource to be used to full advantage for other applications
indicated that DDM as a regenerative biomaterial has potential roles in tissue regeneration. However, to confirm these trials, further well-designed analyses are needed, and an evaluation of adverse events in observational studies is also needed. To our knowledge, DDM has not been investigated as a scaffold in regenerative endodontics for permanent teeth. Several studies evaluated the regenerative effect of DDM on the dentin-pulp complex through the direct pulp capping technique, and it was found to possess the ability to activate the odontogenic differentiation of stem cells resident in the pulp tissues and induce reparative dentin formation. DDM is also considered for the alveolar ridge, maxillary sinus floor augmentations, socket preservation, furcation perforation repair, guided bone, and bio root regenerations as well as bone and cartilage healing
.
Hence, this study will be designed to evaluate the regenerative effect of Demineralized Dentin Matrix as a scaffold in comparison to a conventional blood clot in immature permanent teeth.
- Conditions
- Dental Trauma
- Being tested
- regeneration technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
regeneration techniqueCombination product
Also called regenerative endodontic
clinical procedure of regenerative endodontic as AAE mentioned using different material in each group
| Study group | Role | What they receive |
|---|---|---|
| study group DDM | Experimental | Group I: 10 teeth will be treated with demineralized dentin matrix attached to collagen membrane as a scaffold in the regenerative endodontic procedure. Receives: Combination Product: regeneration technique |
| Control group | Active comparator | Group II: 10 teeth will be treated with the conventional regenerative endodontic procedure (blood clot scaffold). Receives: Combination Product: regeneration technique |
| positive control | Active comparator | Group III: 10 teeth will be treated with collage membrane as a scaffold in the regenerative endodontic procedure Receives: Combination Product: regeneration technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
the elimination of symptoms at base line at 0,3 and 6 and 9and 12 month
no history of pain, using Visual Analog Score for pain, measure quality of life.
soft tissue swelling or sinus tract by visual examination , Sensitivity to percussion, Tooth mobility by clinical assessment by operator
Measured: at 0,3 and 6 and 9and 12 month
Secondary outcomes (1)
change root wall thickness and root length in radiographic measurement in millimeter at 0,3,6,9,12 month
change root length and width measured in mml by digital radiography using parallel technique
Measured: at 0, 3 and 6 and 9and 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2023
- Study start1 Nov 2022
- Primary completion1 Apr 2024 (estimated)
- Study completion1 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental TraumaStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Ahmed Abozed mahmoud, Ain Shams University
- Investigators
- nagwa khattab, professor, Study director, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06006052
- Sponsor's protocol ID
- AnishamsU ASU
- Status last verified
- Aug 2023
- First submitted
- 30 Jul 2023
- Last updated
- 23 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: regeneration immature teeth
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Demineralized Dentin Matrix as a Scaffold for Revascularization in Immature Permanent Incisors: A Randomized Controlled Trial and an In -Vitro Study
- ClinicalTrials.gov ID
- NCT06006052
- Acronym / sponsor ID
- AnishamsU ASU
- Conditions
- Dental Trauma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 1 Jul 2024 (estimated)
- First posted
- 23 Aug 2023 (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.
Compare the clinical and radiographic outcomes of demineralized dentin matrix scaffold to blood clot scaffold in immature permanent incisors with non-vital pulps for one year (in vivo).
Investigate the effect of demineralized dentin matrix (DDM) on dental pulp stem cells (DPSCs) (in vitro).
Detailed description
Necrosis of the immature pulp not only is one of the multiple factors affecting long-term tooth endurance and preservation but also can act as a source of bacterial infection in the periapical area and even the maxillofacial spaces
- The use of regenerative endodontic techniques (RET) have gained popularity in the past decade with several endodontic and pediatric dentistry organization recognizing this technique as a viable technique for immature permanent teeth with necrotic pulps Regenerative endodontics are defined as biologically based techniques planned to physiologically replace impaired tooth structure, including dentin and root constructions, as well as cells of the pulp-dentin complex
- They offer the benefit of root lengthening, thickening, and subsequent apical closure which is not achievable with conventional nonsurgical endodontic treatment (NSET). The success rate of the blood clot (RET) in immature teeth has been reported to be 97.8% .The American Association of Endodontists and the European Society of Endodontology developed evidence-based protocols. To help reduce some of the differences in the RET steps such as EDTA ethylene diamine tetra acetic acid and sodium hypochlorite use, however, variations in terms of intracanal medicament, scaffold, and assessment tools still exist due to the lack of high-quality evidence
A fundamental component of the regenerative endodontic process is the presence of a scaffold for stem cells from the apical papilla to adhere, multiply and differentiate. Based on the results of many studies, the use of blood clot Regenerative procedure is not considered a true scaffold system. But it is an essential part of any appropriately designed tissue engineering regenerative endodontic strategy
.
Different treatment options and scaffolds have been tested in regenerative endodontics. Only
some of them exhibited clinical relevance such as blood clot, platelet-rich plasma, and platelet- rich fibrin as RET scaffolds. Therefore, the use of a suitable scaffold is an essential part of tissue
engineering regenerative endodontic strategy .
Hence, developing a new dental material that retains the proteins or factors that can stimulate regenerative processes close to the natural process seems promising . Tissue-derived extracellular matrices have recently been known as naturally-derived scaffolds for tissue regeneration in various applications and have been revealed to serve as a cultural substrate on which cells tend to adhere to and proliferate well and can induce regeneration specific to tissues and sites
A new extracellular matrix material, demineralized dentin matrix (DDM) derived from extracted teeth has been found to act as a biocompatible scaffold for the attachment, differentiation, and proliferation of human DPSCs (dental pulp stem cell) into odontoblast-like cells . The dentin matrix has proposed roles for directing mineralized tissue repair in dentine and bone; however, the range of bioactive components in dentine and specific biological effects on bone-derived mesenchymal stem cells (MSCs) in humans are less well understood
.
DDM is an autogenous tooth dentin that has osteoconductive and osteoinductive potential since it contains extracellular collagen-1 and various growth factors. DDM as a solid blocky material has less physical stability and sealing ability as a material for regenerative endodontics.
Therefore it has been further fabricated into the forms of DDM powder, gel, and sheets to maintain bioactivity .
DDM can be prepared with low risks of infection and rejection with noninvasive attainability; thus, it should be considered a natural resource to be used to full advantage for other applications
indicated that DDM as a regenerative biomaterial has potential roles in tissue regeneration. However, to confirm these trials, further well-designed analyses are needed, and an evaluation of adverse events in observational studies is also needed. To our knowledge, DDM has not been investigated as a scaffold in regenerative endodontics for permanent teeth. Several studies evaluated the regenerative effect of DDM on the dentin-pulp complex through the direct pulp capping technique, and it was found to possess the ability to activate the odontogenic differentiation of stem cells resident in the pulp tissues and induce reparative dentin formation. DDM is also considered for the alveolar ridge, maxillary sinus floor augmentations, socket preservation, furcation perforation repair, guided bone, and bio root regenerations as well as bone and cartilage healing
.
Hence, this study will be designed to evaluate the regenerative effect of Demineralized Dentin Matrix as a scaffold in comparison to a conventional blood clot in immature permanent teeth.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| study group DDM | Experimental | Combination Product: regeneration techniqueGroup I: 10 teeth will be treated with demineralized dentin matrix attached to collagen membrane as a scaffold in the regenerative endodontic procedure. |
| Control group | Active comparator | Combination Product: regeneration techniqueGroup II: 10 teeth will be treated with the conventional regenerative endodontic procedure (blood clot scaffold). |
| positive control | Active comparator | Combination Product: regeneration techniqueGroup III: 10 teeth will be treated with collage membrane as a scaffold in the regenerative endodontic procedure |
Who may qualify
- Ages
- 7 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (0 listed)
Key exclusion criteria (6 listed)
- the patients will excluded if one of the following criteria is present in the patients
- Teeth with root fractures.
- Presence of internal or external root resorptions.
- Developmental anomalies of the root.
- Presence of periapical radiolucency more than 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 |
|---|---|---|
| regeneration techniqueAlso: regenerative endodonticclinical procedure of regenerative endodontic as AAE mentioned using different material in each group | Combination product | Control group, positive control, study group DDM |
Primary outcome
the elimination of symptoms at base line at 0,3 and 6 and 9and 12 month
Time frame: at 0,3 and 6 and 9and 12 month
no history of pain, using Visual Analog Score for pain, measure quality of life. soft tissue swelling or sinus tract by visual examination , Sensitivity to percussion, Tooth mobility by clinical assessment by operator
1 secondary outcome
change root wall thickness and root length in radiographic measurement in millimeter at 0,3,6,9,12 month
Time frame: at 0, 3 and 6 and 9and 12 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2023.
- Regeneration of Tooth with Allogenous, Autoclaved Treated Dentin Matrix with Dental Pulpal Stem Cells: An In Vivo StudyLink provided by the sponsor.
- Individual participant dataSharing planned: No. regeneration immature 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. This study is not recruiting at the moment.
nagwa khattab, professor study director
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing regeneration technique in people with Dental Trauma, 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 0 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 23 Aug 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marwa Abozed (00201142621411, marwaabozed@dent.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the elimination of symptoms at base line at 0,3 and 6 and 9and 12 month (time frame: at 0,3 and 6 and 9and 12 month). 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 Aug 2023.