Pulpotomy of Young Permanent MolarsPhase 1/2NCT06116695
Tomographic Evaluation of Pulpotomy in Young Permanent Teeth Using Human-treated Dentin Matrix
A Phase 1/2 study testing human treated dentin matrix and Mineral Tri-Oxide Aggregate in people with Pulpotomy of Young Permanent Molars, run by Tanta University at 1 site in Egypt.
Trial summary
Assess tomographic outcomes of pulpotomy in young permanent molars using human-treated dentin matrix versus MTA. Read more about this study
- Who is it for?
- Ages 6 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulpotomy of Young Permanent Molars
- What is being tested?
- human treated dentin matrix and Mineral Tri-Oxide Aggregate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 18 Jan 2022to 18 Oct 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: Tomographic Evaluation of Apexogenesis With Human Treated Dentin Matrix in Young Permanent Molars
Assess tomographic outcomes of pulpotomy in young permanent molars using human-treated dentin matrix versus 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 pulpotomy procedure.The selected deeply carious molars were randomly divided into two groups as follows:
Group I (Study group): 20 molars were treated with hTDM. Group II:
(Control group): 20 molars were treated with White MTA. The participating cases were evaluated clinically 3, 6, 12 and 18 months. Digital periapical radiographs was taken at 6 month follow-up period to ensure the state of the treated teeth or if there was necessary condition.
Tomographic evaluation was performed immediate postoperatively and at 18 months.
- Conditions
- Pulpotomy of Young Permanent Molars
- Being tested
- human treated dentin matrix, Mineral Tri-Oxide 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 Tri-Oxide AggregateDrug
mineral trioxide aggregate was used as control
| Study group | Role | What they receive |
|---|---|---|
| human-treated dentin matrix | Experimental | drug: Human-treated dentin matrix young permanent molars treated with human-treated dentin matrix Receives: Drug: human treated dentin matrix |
| mineral tri oxide aggregate | Placebo comparator | Drug: Mineral Trioxide Aggregate young permanent molars treated with Mineral Trioxide Aggregate mineral trioxide aggregate was used as control Receives: Drug: Mineral Tri-Oxide Aggregate |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical outcomes
Absence of pain related to the treated teeth, including pain or sensitivity to percussion/palpation, No evidence of swelling or presence of a sinus tract, Absence of mobility affecting the treated teeth
Measured: 18 months
Tomographic outcomes
Continuous increase in root length and decrease in the apical diameter, Absence of radicular, interradicular and periradicular rarefaction, No loss of the lamina dura.
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 posted3 Nov 2023
- Study start18 Jan 2022
- Primary completion18 Jun 2023
- Study completion18 Oct 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 Pulpotomy of Young Permanent MolarsStudies of the same condition, open and under way.
- More trials run by Tanta 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 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
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, nora mostafa mohammed abo shanady, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06116695
- Sponsor's protocol ID
- 11-21-1
- Status last verified
- Jul 2024
- First submitted
- 27 Oct 2023
- Last updated
- 31 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 28198096Shanady NMA, Abo Hamila NA, El Maghraby GM, Ghouraba RF. Tomographic evaluation of apexogenesis with human treated dentin matrix in young permanent molars: a split-mouth randomized controlled clinical trial. BMC Oral Health. 2025 May 7;25(1):692. doi: 10.1186/s12903-025-05997-1.
PubMed 40335983
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tomographic Evaluation of Apexogenesis With Human Treated Dentin Matrix in Young Permanent Molars
- ClinicalTrials.gov ID
- NCT06116695
- Acronym / sponsor ID
- 11-21-1
- Conditions
- Pulpotomy of Young Permanent Molars
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 18 Jan 2022 (actual)
- Primary completion
- 18 Jun 2023 (actual)
- Study completion
- 18 Oct 2023 (actual)
- First posted
- 3 Nov 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 tomographic outcomes of pulpotomy in young permanent molars using human-treated dentin matrix versus 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 pulpotomy procedure.The selected deeply carious molars were randomly divided into two groups as follows:
Group I (Study group): 20 molars were treated with hTDM. Group II:
(Control group): 20 molars were treated with White MTA. The participating cases were evaluated clinically 3, 6, 12 and 18 months. Digital periapical radiographs was taken at 6 month follow-up period to ensure the state of the treated teeth or if there was necessary condition.
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 matrixdrug: Human-treated dentin matrix young permanent molars treated with human-treated dentin matrix |
| mineral tri oxide aggregate | Placebo comparator | Drug: Mineral Tri-Oxide AggregateDrug: Mineral Trioxide Aggregate young permanent molars treated with Mineral Trioxide Aggregate mineral trioxide aggregate was used as control |
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 Tri-Oxide Aggregatemineral trioxide aggregate was used as control | Drug | mineral tri oxide aggregate |
Primary outcome
clinical outcomes
Time frame: 18 months
Absence of pain related to the treated teeth, including pain or sensitivity to percussion/palpation, No evidence of swelling or presence of a sinus tract, Absence of mobility affecting the treated teeth
Tomographic outcomes
Time frame: 18 months
Continuous increase in root length and decrease in the apical diameter, Absence of radicular, interradicular and periradicular rarefaction, No loss of the lamina dura.
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 31 Jul 2024.
- Results publication: 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.
- Results publication: 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.
- Results publication: 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.
- Results publication: 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.
- Derived from this study: PubMed 40335983Shanady NMA, Abo Hamila NA, El Maghraby GM, Ghouraba RF. Tomographic evaluation of apexogenesis with human treated dentin matrix in young permanent molars: a split-mouth randomized controlled clinical trial. BMC Oral Health. 2025 May 7;25(1):692. doi: 10.1186/s12903-025-05997-1.
- Individual participant dataSharing planned: Undecided
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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 Tri-Oxide Aggregate in people with Pulpotomy of Young Permanent Molars, run by Tanta 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 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 31 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. Some participants in this study may receive a placebo. 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 outcomes (time frame: 18 months). The study lists 2 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 NCT06116695, 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 31 Jul 2024.