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Active, not recruitingNCT07207382Updated Apr 13, 2026

Clinical and Radiographic Evaluation of Three Biomimetic Materials in Pulp Therapy of Immature Young Permanent Teeth "A Randomized Controlled Clinical Trial"

A Phase 3 interventional study of MTA group and Premixed Bioceramic material in Pulpotomy of Young Permanent Molars, sponsored by Ain Shams University. Active, not recruiting at 1 site in Egypt. Open to participants aged 7 Years to 10 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-13.

Sponsored by Ain Shams University · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 7 months after the study started (first participant enrolled Feb 2024, registered Oct 2025).
Phase
Phase 3
Study type
Interventional
Enrollment
69
Allocation
Randomized
Ages
7 Years to 10 Years
Sex
All
01

Study summary

Statement of the problem:

Pulpotomy is the most popular technique for maintaining vitality and has a substantial impact on continuing root growth in vital, young permanent molars suffering from dental cavities.

Biomimetic materials placement after performing pulp therapy is one of the important factors to determine healing of the pulp and continue root formation. In this study a novel material "Treated Dentin Matrix" is used in comparison to premixed bioceramic material and "Mineral Trioxide Aggregate" in pulpotomy of immature permanent molars.

The Aim of the study:

Is to assess the clinical and radiographic success of pulpotomized first permanent immature molars treated with three different Biomimetic materials (Treated Dentin Matrix, Premixed Bio-ceramic material and Mineral Trioxide Aggregate)

02

Conditions studied

  • Pulpotomy of Young Permanent Molars

Keywords

  • young permanent
  • MTA
  • Pulpotomy
  • premixed bioceramic
  • treated dentin matrix
03

In context

Lead sponsor

Ain Shams University is the lead sponsor of 1,876 studies on the registry; 423 are open to participants now.

Of its 32 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
7 Years to 10 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Children aged between 7 and 10 years-old.
  • Vital permanent first molars with deep caries lesion approaches the pulp without symptoms of irreversible pulpitis, with open apices in the radiograph.
  • Permanent first molars with pulpal exposure that occurred during caries excavation.
  • Incompletely formed roots

Exclusion criteria

Exclusion Criteria:

  • Teeth with signs and symptoms of chronic infection such as swelling and mobility.
  • Teeth with excessive bleeding from amputated radicular stumps
  • Teeth showing radiographic evidence of pathologic root resorption, inter-radicular bone loss, periapical pathology and calcifications in the canals.
  • Lack of patient/parent compliance and cooperation.
  • Children who are physically or mentally disabled or having any medical condition that will complicate the treatment
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
69 participants (actual)

Study arms

  • Active comparator
    A

    Drug: MTA group

  • Experimental
    B

    Drug: Premixed Bioceramic material

  • Experimental
    C

    Drug: Treated Dentin Matrix

Interventions

  • DrugMTA group

    MTA group is considered the control group

  • DrugPremixed Bioceramic material

    Premixed Bioceramic material is test group B

  • DrugTreated Dentin Matrix

    Treated Dentin Matrix is test group C

06

What researchers measure

Primary outcomes

  1. Clinical success

    * Absence of pain related to the treated teeth, Including patient reported pain or sensitivity to percussion/palpation. * No evidence of swelling of supporting soft tissue or presence of sinus tract. * Absence of excessive mobility affecting treated teeth.

    Time frame: 18 months

  2. Radiographic success

    * Radiographic criteria for success in terms of: * Progression of root formation * No Internal or external root resorption. * No Periapical or furcal radiolucency.

    Time frame: 18 months

07

Study locations

1 site
  • Ain Shams University
    Cairo, Egypt
08

References and documents

Individual participant data

Plan to share: No

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 Apr 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07207382
Lead sponsor
Ain Shams University
Responsible party
Sarah Mohamed Fakhry (Principle Investigator, Ain Shams University) — Principal investigator
First posted
Oct 6, 2025
Start date
Feb 20, 2024
Primary completion
Aug 1, 2026 (estimated)
Completion
Oct 1, 2026 (estimated)
Last update
Apr 13, 2026

Oversight

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

Not currently enrolling

This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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