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NCT Number: NCT07207382

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

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)

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Pulpotomy of Young Permanent Molars

Age range

7 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Ain Shams University

Cairo, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

MTA group

Drug

MTA group is considered the control group

Premixed Bioceramic material

Drug

Premixed Bioceramic material is test group B

Treated Dentin Matrix

Drug

Treated Dentin Matrix is test group C

Primary outcomes

  1. Clinical success

    Time frame: 18 months

    • 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.

  2. Radiographic success

    Time frame: 18 months

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

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Oct 6, 2025
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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