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Completed

NCT Number: NCT05830695

Evaluation of Apexogenesis With Human Treated Dentin Matrix in Young Permanent Molars

Assess the clinical, radiographic, and tomographic outcomes of apexogenesis with human treated dentin matrix in young permanent molars compared to MTA.

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Key information

Conditions

Dentin Bridge

Age range

6 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Faculty of Dentistry, Tanta University

Tanta, El Gharbia, 31111, Egypt

About this study

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 vital pulp therapy.The selected deeply carious molars were randomly divided into two groups as follows:

Group I (Study group): 20 molars were treated with human TDM. Group II: (Control group): 20 molars were treated with White MTA. The participating cases were evaluated clinically and radiographically after 6, 12 and 18 months. Tomographic evaluation was performed immediate postoperatively and at 18 months.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

human treated dentin matrix

Drug

human treated dentin matrix is compared with mineral trioxide aggregate in apexogenesis

Other names: human partially demineralized treated dentin matrix

Mineral Trioxide Aggregate

Drug

mineral trioxide aggregate was used as control

Other names: MTA

Primary outcomes

  1. clinical outcome

    Time frame: 18 months

    patient reported pain or tenderness on palpation or percussion

  2. clinical outcome

    Time frame: 18 months

    patient/ clinician observed swelling or sinus tract observation

  3. clinical outcome

    Time frame: 18 months

    tooth mobility clinically assessed by grades

  4. radiographic outcomes

    Time frame: 18 months

    radicular changes assessed by clinician from digital periapical radiograph

  5. radiographic outcomes

    Time frame: 18 months

    interradicular changes assessed by clinician from digital periapical radiograph

  6. radiographic outcomes

    Time frame: 18 months

    peri-radicular changes assessed by clinician from digital periapical radiograph

  7. tomographic evaluation

    Time frame: 18 months

    evidence of continuity of root development measured from cone beam computed tomography

Sponsors and collaborators

Lead sponsor

nora mostafa mohammed abo shanady

Other

Registry information

Official study title

Clinical, Radiographic and Tomographic Evaluation of Apexogenesis With Human Treated Dentin Matrix in Young Permanent Molars

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Apr 26, 2023
Registry last updated
Jul 30, 2024

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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