Deep Carious Young 1st Permanent Molar With Open ApexNCT05790629
Three Dimensional Evaluation of Apexogenesis of Immature Young Permanent Teeth With Different Endodontic Material
A study testing endo-sequence putty and neo-MTA putty in people with Deep Carious Young 1st Permanent Molar With Open Apex, run by Al-Azhar University at 1 site in Egypt.
Trial summary
Randomized Clinical Trial using Three Dimensional Evaluation of Apexogensis of immature young permanent teeth with Different Endodontic Tri-calcium Silicate-Based Putties Read more about this study
- Who is it for?
- Ages 6 to 9 years
- Conditions the study is for
- Deep Carious Young 1st Permanent Molar With Open Apex
- What is being tested?
- endo-sequence putty and neo-MTA putty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteEgypt
- Study dates
- 8 Aug 2022to May 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 6 to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- First permanent molar with pulpitis.
- Sufficient tooth structure for placing rubber dam.
- Presence of open apex.
- Short root length.
Who cannot join
- Insufficient tooth structure that need post and core.
- Presence of swelling.
- Presence of sinus tract.
- Presence of root fracture.
- Presence of root crack.
- Presence of external or internal root resorption.
- Presence of periapical pathosis.
- Presence of root calcification.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Al-Azhar university dental clinics and 6 October university dental clinics
Cairo, Choose A State Or Province, 00040
alaa mohammed, 01068837641, alaaaldehna.26@azhar.edu.eg
About this study
Official title: Three Dimensional Evaluation of Apexogenesis of Immature Young Permanent Teeth With Different Endodontic Tri-calcium Silicate-Based Putties: Randomized Clinical Trial
Randomized Clinical Trial using Three Dimensional Evaluation of Apexogensis of immature young permanent teeth with Different Endodontic Tri-calcium Silicate-Based Putties
Read the detailed description
Treatment of immature permanent teeth has always been challenging in endodontics, not only because of their wide-open root apices but also because of the thin underdeveloped dentinal walls.Apexogenesis falls under the category of vital pulp therapy (VPT) procedure to maintain pulp vitality, induce dentin bridge formation and encourage continued root maturation.
To overcome the drawbacks of tricalcium silicate-based cements, a range of bioactive endodontic cements have been developed.
EndoSequence BC RRM-Fast Set Putty and NeoPutty (NuSmile, Houston, TX, USA) are the two materials evaluated in this study.
- Being tested
- endo-sequence putty, neo-MTA putty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endo-sequence puttyProcedure or surgery
Also called Endodontic Tri-calcium Silicate-Based Puty
pupal medicament which is materials used in case of vital pulp therapy (VPT) procedure after opening access in the inflamed pulp to maintain it is vitality, inducing dentin bridge formation and encourage continued root maturation.
neo-MTA puttyProcedure or surgery
Also called Endodontic Tri-calcium Silicate-Based Puty
pupal medicament which is materials used in case of vital pulp therapy (VPT) procedure after opening access in the inflamed pulp to maintain it is vitality, inducing dentin bridge formation and encourage continued root maturation.
| Study group | Role | What they receive |
|---|---|---|
| Group (I) control | Active comparator | young permanent pulpy exposed carious tooth of the selected participants will be treated with specific technique called apexogenesis using bio-compatible material (endo-sequence putty ). This material is administrated to the tooth by placing about 2-4 mm bulk of material in the pulp champers at the cervical line then sealing the capping material with glass ionomer and stainless steel crown. Receives: Procedure: endo-sequence putty |
| Group (II) | Experimental | young permanent pulpy exposed carious tooth of the selected participants will be treated with specific technique called apexogenesis using bio-compatible material (neo-MTA putty). This material is administrated to the tooth by placing about 2-4 mm bulk of material in the pulp champers at the cervical line then sealing the capping material with glass ionomer and stainless steel crown. Receives: Procedure: neo-MTA putty |
What is being measured
The primary outcome is the main question the study is designed to answer.
asymptomatic
pain relief after procedure by Numeric rating scales on follow up visits.Most pain scales use numbers from 0 to 10. A score of 0 means no pain, and 10 means the worst pain you have ever felt.
Measured: one year
Secondary outcomes (1)
complete root maturation
increasing the length the root till the apex closure which is determined by cone beam analysis
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2023
- Study start8 Aug 2022
- Primary completionApr 2024 (estimated)
- Study completionMay 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deep Carious Young 1st Permanent Molar With Open ApexStudies of the same condition, open and under way.
- More trials run by Al-Azhar 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa M Eldehna, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05790629
- Sponsor's protocol ID
- P-PD-22-26
- Status last verified
- Mar 2023
- First submitted
- 1 Feb 2023
- Last updated
- 30 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Three Dimensional Evaluation of Apexogenesis of immature young permanent teeth with Different Endodontic Tri-calcium Silicate-Based Putties: Randomized Clinical Trial
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Three Dimensional Evaluation of Apexogenesis of Immature Young Permanent Teeth With Different Endodontic Tri-calcium Silicate-Based Putties: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05790629
- Acronym / sponsor ID
- P-PD-22-26
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 8 Aug 2022 (actual)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- May 2024 (estimated)
- First posted
- 30 Mar 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.
Randomized Clinical Trial using Three Dimensional Evaluation of Apexogensis of immature young permanent teeth with Different Endodontic Tri-calcium Silicate-Based Putties
Detailed description
Treatment of immature permanent teeth has always been challenging in endodontics, not only because of their wide-open root apices but also because of the thin underdeveloped dentinal walls.Apexogenesis falls under the category of vital pulp therapy (VPT) procedure to maintain pulp vitality, induce dentin bridge formation and encourage continued root maturation.
To overcome the drawbacks of tricalcium silicate-based cements, a range of bioactive endodontic cements have been developed.
EndoSequence BC RRM-Fast Set Putty and NeoPutty (NuSmile, Houston, TX, USA) are the two materials evaluated in this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group (I) control | Active comparator | Procedure: endo-sequence puttyyoung permanent pulpy exposed carious tooth of the selected participants will be treated with specific technique called apexogenesis using bio-compatible material (endo-sequence putty ). This material is administrated to the tooth by placing about 2-4 mm bulk of material in the pulp champers at the cervical line then sealing the capping material with glass ionomer and stainless steel crown. |
| Group (II) | Experimental | Procedure: neo-MTA puttyyoung permanent pulpy exposed carious tooth of the selected participants will be treated with specific technique called apexogenesis using bio-compatible material (neo-MTA putty). This material is administrated to the tooth by placing about 2-4 mm bulk of material in the pulp champers at the cervical line then sealing the capping material with glass ionomer and stainless steel crown. |
Who may qualify
- Ages
- 6 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- First permanent molar with pulpitis.
- Sufficient tooth structure for placing rubber dam.
- Presence of open apex.
- Short root length.
Key exclusion criteria (8 listed)
- Insufficient tooth structure that need post and core.
- Presence of swelling.
- Presence of sinus tract.
- Presence of root fracture.
- Presence of root crack.
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 |
|---|---|---|
| endo-sequence puttyAlso: Endodontic Tri-calcium Silicate-Based Putypupal medicament which is materials used in case of vital pulp therapy (VPT) procedure after opening access in the inflamed pulp to maintain it is vitality, inducing dentin bridge formation and encourage continued root maturation. | Procedure or surgery | Group (I) control |
| neo-MTA puttyAlso: Endodontic Tri-calcium Silicate-Based Putypupal medicament which is materials used in case of vital pulp therapy (VPT) procedure after opening access in the inflamed pulp to maintain it is vitality, inducing dentin bridge formation and encourage continued root maturation. | Procedure or surgery | Group (II) |
Primary outcome
asymptomatic
Time frame: one year
pain relief after procedure by Numeric rating scales on follow up visits.Most pain scales use numbers from 0 to 10. A score of 0 means no pain, and 10 means the worst pain you have ever felt.
1 secondary outcome
complete root maturation
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2023.
- Individual participant dataSharing planned: No. Three Dimensional Evaluation of Apexogenesis of immature young permanent teeth with Different Endodontic Tri-calcium Silicate-Based Putties: Randomized Clinical Trial
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing endo-sequence putty and neo-MTA putty in people with Deep Carious Young 1st Permanent Molar With Open Apex, 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 4 inclusion and 8 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 30 Mar 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 alaa M mohammed, Ph. D (+201068837641, alaaaldehna.26@azhar.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
asymptomatic (time frame: one 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 30 Mar 2023; AzTrials last refreshed its copy on 7 Nov 2026.