Dentin BridgePhase 1/2NCT05830695
Evaluation of Apexogenesis With Human Treated Dentin Matrix in Young Permanent Molars
A Phase 1/2 study testing human treated dentin matrix and Mineral Trioxide Aggregate in people with Dentin Bridge, run by nora mostafa mohammed abo shanady at 1 site in Egypt.
Trial summary
Assess the clinical, radiographic, and tomographic outcomes of apexogenesis with human treated dentin matrix in young permanent molars compared to MTA. Read more about this study
- Who is it for?
- Ages 6 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Dentin Bridge
- What is being tested?
- human treated dentin matrix and Mineral Trioxide Aggregate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 18 Jan 2022to 31 Mar 2023
- Phase
- Phase 1/2
- 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 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Bilateral immature permanent mandibular first molars with deep carious lesions.
- Positive response to pulp testing.
- Normal radiographic appearance.
- Healthy children without any systemic disease that interferes with pulp healing.
- Patient and parent cooperation.
Who cannot join
- Clinical signs and symptoms of irreversible pulpitis as spontaneous throbbing pain, tenderness to percussion, abnormal tooth mobility, swelling, or sinus tract.
- Presence of periapical lesion, external or internal root resorption.
- Carious furcation involvement.
- Dystrophic calcification of the pulp.
- Non restorable tooth.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical, Radiographic and Tomographic Evaluation of Apexogenesis With Human Treated Dentin Matrix in Young Permanent Molars
Assess the clinical, radiographic, and tomographic outcomes of apexogenesis with human treated dentin matrix in young permanent molars compared to MTA.
Read the detailed description
The study was conducted as a split-mouth randomized clinical trial, approved by research ethics committee, Faculty of Dentistry, Tanta University, and carried out at Pediatric Dentistry Department, Faculty of Dentistry, Tanta University. The material preparation was conducted at Pharmaceutical Technology Department, Faculty of Pharmacy, Tanta University. 20 children of both sexes aged from 6 to 8 years old were selected with bilateral deeply carious young permanent mandibular first molars that are indicated for vital pulp therapy.The selected deeply carious molars were randomly divided into two groups as follows:
Group I (Study group): 20 molars were treated with human TDM. Group II: (Control group): 20 molars were treated with White MTA. The participating cases were evaluated clinically and radiographically after 6, 12 and 18 months. Tomographic evaluation was performed immediate postoperatively and at 18 months.
- Conditions
- Dentin Bridge
- Being tested
- human treated dentin matrix, Mineral Trioxide Aggregate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
human treated dentin matrixDrug
Also called human partially demineralized treated dentin matrix
human treated dentin matrix is compared with mineral trioxide aggregate in apexogenesis
Mineral Trioxide AggregateDrug
Also called MTA
mineral trioxide aggregate was used as control
| Study group | Role | What they receive |
|---|---|---|
| human treated dentin matrix | Experimental | study group Receives: Drug: human treated dentin matrix |
| mineral tri oxide aggregate | Experimental | control group Receives: Drug: Mineral Trioxide Aggregate |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical outcome
patient reported pain or tenderness on palpation or percussion
Measured: 18 months
clinical outcome
patient/ clinician observed swelling or sinus tract observation
Measured: 18 months
clinical outcome
tooth mobility clinically assessed by grades
Measured: 18 months
radiographic outcomes
radicular changes assessed by clinician from digital periapical radiograph
Measured: 18 months
radiographic outcomes
interradicular changes assessed by clinician from digital periapical radiograph
Measured: 18 months
radiographic outcomes
peri-radicular changes assessed by clinician from digital periapical radiograph
Measured: 18 months
tomographic evaluation
evidence of continuity of root development measured from cone beam computed tomography
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2023
- Study start18 Jan 2022
- Primary completion18 Jul 2022
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Dentin BridgeStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- nora mostafa mohammed abo shanady
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, nora mostafa mohammed abo shanady, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05830695
- Sponsor's protocol ID
- 12-3456
- Status last verified
- Jul 2024
- First submitted
- 31 Mar 2023
- Last updated
- 30 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Li R, Guo W, Yang B, Guo L, Sheng L, Chen G, Li Y, Zou Q, Xie D, An X, Chen Y, Tian W. Human treated dentin matrix as a natural scaffold for complete human dentin tissue regeneration. Biomaterials. 2011 Jul;32(20):4525-38. doi: 10.1016/j.biomaterials.2011.03.008. Epub 2011 Mar 31.
PubMed 21458067Tabatabaei FS, Tatari S, Samadi R, Torshabi M. Surface characterization and biological properties of regular dentin, demineralized dentin, and deproteinized dentin. J Mater Sci Mater Med. 2016 Nov;27(11):164. doi: 10.1007/s10856-016-5780-8. Epub 2016 Sep 21.
PubMed 27655430Widbiller M, Eidt A, Wolflick M, Lindner SR, Schweikl H, Hiller KA, Buchalla W, Galler KM. Interactive effects of LPS and dentine matrix proteins on human dental pulp stem cells. Int Endod J. 2018 Aug;51(8):877-888. doi: 10.1111/iej.12897. Epub 2018 Feb 17.
PubMed 29377169Chen J, Cui C, Qiao X, Yang B, Yu M, Guo W, Tian W. Treated dentin matrix paste as a novel pulp capping agent for dentin regeneration. J Tissue Eng Regen Med. 2017 Dec;11(12):3428-3436. doi: 10.1002/term.2256. Epub 2017 Feb 15.
PubMed 28198096Mehrvarzfar P, Abbott PV, Mashhadiabbas F, Vatanpour M, Tour Savadkouhi S. Clinical and histological responses of human dental pulp to MTA and combined MTA/treated dentin matrix in partial pulpotomy. Aust Endod J. 2018 Apr;44(1):46-53. doi: 10.1111/aej.12217. Epub 2017 Aug 18.
PubMed 28833942
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical, Radiographic and Tomographic Evaluation of Apexogenesis With Human Treated Dentin Matrix in Young Permanent Molars
- ClinicalTrials.gov ID
- NCT05830695
- Acronym / sponsor ID
- 12-3456
- Conditions
- Dentin Bridge
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- nora mostafa mohammed abo shanadyUniversity, hospital or other
- Study start
- 18 Jan 2022 (actual)
- Primary completion
- 18 Jul 2022 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 26 Apr 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.
Assess the clinical, radiographic, and tomographic outcomes of apexogenesis with human treated dentin matrix in young permanent molars compared to MTA.
Detailed description
The study was conducted as a split-mouth randomized clinical trial, approved by research ethics committee, Faculty of Dentistry, Tanta University, and carried out at Pediatric Dentistry Department, Faculty of Dentistry, Tanta University. The material preparation was conducted at Pharmaceutical Technology Department, Faculty of Pharmacy, Tanta University. 20 children of both sexes aged from 6 to 8 years old were selected with bilateral deeply carious young permanent mandibular first molars that are indicated for vital pulp therapy.The selected deeply carious molars were randomly divided into two groups as follows:
Group I (Study group): 20 molars were treated with human TDM. Group II: (Control group): 20 molars were treated with White MTA. The participating cases were evaluated clinically and radiographically after 6, 12 and 18 months. Tomographic evaluation was performed immediate postoperatively and at 18 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| human treated dentin matrix | Experimental | Drug: human treated dentin matrixstudy group |
| mineral tri oxide aggregate | Experimental | Drug: Mineral Trioxide Aggregatecontrol group |
Who may qualify
- Ages
- 6 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Bilateral immature permanent mandibular first molars with deep carious lesions.
- Positive response to pulp testing.
- Normal radiographic appearance.
- Healthy children without any systemic disease that interferes with pulp healing.
- Patient and parent cooperation.
Key exclusion criteria (5 listed)
- Clinical signs and symptoms of irreversible pulpitis as spontaneous throbbing pain, tenderness to percussion, abnormal tooth mobility, swelling, or sinus tract.
- Presence of periapical lesion, external or internal root resorption.
- Carious furcation involvement.
- Dystrophic calcification of the pulp.
- Non restorable tooth.
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 matrixAlso: human partially demineralized treated dentin matrixhuman treated dentin matrix is compared with mineral trioxide aggregate in apexogenesis | Drug | human treated dentin matrix |
| Mineral Trioxide AggregateAlso: MTAmineral trioxide aggregate was used as control | Drug | mineral tri oxide aggregate |
Primary outcome
clinical outcome
Time frame: 18 months
patient reported pain or tenderness on palpation or percussion
clinical outcome
Time frame: 18 months
patient/ clinician observed swelling or sinus tract observation
clinical outcome
Time frame: 18 months
tooth mobility clinically assessed by grades
radiographic outcomes
Time frame: 18 months
radicular changes assessed by clinician from digital periapical radiograph
radiographic outcomes
Time frame: 18 months
interradicular changes assessed by clinician from digital periapical radiograph
radiographic outcomes
Time frame: 18 months
peri-radicular changes assessed by clinician from digital periapical radiograph
tomographic evaluation
Time frame: 18 months
evidence of continuity of root development measured from cone beam computed tomography
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 30 Jul 2024.
- Background: PubMed 21458067Li R, Guo W, Yang B, Guo L, Sheng L, Chen G, Li Y, Zou Q, Xie D, An X, Chen Y, Tian W. Human treated dentin matrix as a natural scaffold for complete human dentin tissue regeneration. Biomaterials. 2011 Jul;32(20):4525-38. doi: 10.1016/j.biomaterials.2011.03.008. Epub 2011 Mar 31.
- Background: PubMed 27655430Tabatabaei FS, Tatari S, Samadi R, Torshabi M. Surface characterization and biological properties of regular dentin, demineralized dentin, and deproteinized dentin. J Mater Sci Mater Med. 2016 Nov;27(11):164. doi: 10.1007/s10856-016-5780-8. Epub 2016 Sep 21.
- Background: PubMed 29377169Widbiller M, Eidt A, Wolflick M, Lindner SR, Schweikl H, Hiller KA, Buchalla W, Galler KM. Interactive effects of LPS and dentine matrix proteins on human dental pulp stem cells. Int Endod J. 2018 Aug;51(8):877-888. doi: 10.1111/iej.12897. Epub 2018 Feb 17.
- Background: PubMed 28198096Chen J, Cui C, Qiao X, Yang B, Yu M, Guo W, Tian W. Treated dentin matrix paste as a novel pulp capping agent for dentin regeneration. J Tissue Eng Regen Med. 2017 Dec;11(12):3428-3436. doi: 10.1002/term.2256. Epub 2017 Feb 15.
- Background: PubMed 28833942Mehrvarzfar P, Abbott PV, Mashhadiabbas F, Vatanpour M, Tour Savadkouhi S. Clinical and histological responses of human dental pulp to MTA and combined MTA/treated dentin matrix in partial pulpotomy. Aust Endod J. 2018 Apr;44(1):46-53. doi: 10.1111/aej.12217. Epub 2017 Aug 18.
- 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.
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 Phase 1/2 study testing human treated dentin matrix and Mineral Trioxide Aggregate in people with Dentin Bridge, run by nora mostafa mohammed abo shanady 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 5 inclusion and 5 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 30 Jul 2024. 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.
What does this combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
clinical outcome (time frame: 18 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05830695, which also lists 5 linked publications.
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 30 Jul 2024.