CClinicalTrials.gg
Status unknownNCT05790629Updated Mar 30, 2023

Three Dimensional Evaluation of Apexogenesis of Immature Young Permanent Teeth With Different Endodontic Material

An interventional study of endo-sequence putty and neo-MTA putty in Deep Carious Young 1st Permanent Molar With Open Apex, sponsored by Al-Azhar University. Status unknown at 1 site in Egypt. Open to participants aged 6 Years to 9 Years. Per ClinicalTrials.gov, last updated 2023-03-30.

Sponsored by Al-Azhar University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2023), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Aug 2022, registered Feb 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
6 Years to 9 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Deep Carious Young 1st Permanent Molar With Open Apex
03

In context

Lead sponsor

Al-Azhar University is the lead sponsor of 505 studies on the registry; 167 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 9 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • First permanent molar with pulpitis.
  • Sufficient tooth structure for placing rubber dam.
  • Presence of open apex.
  • Short root length.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
48 participants (estimated)

Study arms

  • Active comparator
    Group (I) control

    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.

    Procedure: endo-sequence putty

  • Experimental
    Group (II)

    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.

    Procedure: neo-MTA putty

Interventions

  • Procedureendo-sequence putty

    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.

    Also known as: Endodontic Tri-calcium Silicate-Based Puty

  • Procedureneo-MTA putty

    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.

    Also known as: Endodontic Tri-calcium Silicate-Based Puty

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: one year

Secondary outcomes

  1. complete root maturation

    increasing the length the root till the apex closure which is determined by cone beam analysis

    Time frame: one year

Other outcomes

  1. maintain pulp vitality

    Positive response to sensibility testing. it evaluates the condition of the Pulp Being Very Responsive to a hot and cold Stimulus The pulp is deemed normal when there is a response to the stimulus. Pulpitis is present when there is an exaggerated response that produces pain. The absence of responses to sensibility tests is usually associated with the likelihood of pulp necrosis, the tooth is pulpless,

    Time frame: one year

07

Study locations

1 of 1 sites recruiting
  • Al-Azhar university dental clinics and 6 October university dental clinics
    Cairo, Choose A State Or Province 00040, Egypt
    Recruiting
08

References and documents

Individual participant data

Plan to share: No — Three Dimensional Evaluation of Apexogenesis of immature young permanent teeth with Different Endodontic Tri-calcium Silicate-Based Putties: Randomized Clinical Trial

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 30, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05790629
Lead sponsor
Al-Azhar University
Responsible party
Alaa M Eldehna (lecturer of Pediatric dentistry, Al-Azhar University) — Principal investigator
First posted
Mar 30, 2023
Start date
Aug 8, 2022
Primary completion
Apr 2024 (estimated)
Completion
May 2024 (estimated)
Last update
Mar 30, 2023

Study contacts

alaa M mohammed, Ph. D
Contact
alaaaldehna.26@azhar.edu.eg
+201068837641

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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