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Completed

NCT Number: NCT03589560

Evaluation of Biodentine and Mineral Trioxide Aggregate in Revascularization of Non Vital Immature Anterior Teeth

the object of this study is to evaluate clinically and radiographically the effect of using Biodentine and Mineral Trioxide Aggregate as coronal plug materials in revascularization of non-vital immature teeth

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Key information

Age range

8 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Traumatic injury to the anterior teeth is commonly found among young children, represent one third in boys and one fourth in girls. Because the root development completed two years after eruption of the tooth into the oral cavity, an incomplete root development is one of the most common complication seen in traumatized teeth. Loss of pulp vitality before dentine deposition is completed, leaves a weak root more susceptible to fracture as a result of the thin dentinal walls. It will also lead to a poor crown/root ratio, with possible periodontal injury as a result of increased mobility.

Several techniques have been advocated to manage the open apex of immature teeth, including calcium hydroxide (Ca(OH)2) apexification or apical barrier technique with Mineral Trioxide Aggregate (MTA). Although these techniques were successful in obtaining apical closure and healing of the apical pathosis, they have certain disadvantages, as the root walls of the immature tooth remain thin and short as hard tissue barrier formation only occurs apically, with no further root development.

As an replacement to traditional methods, the use of a regenerative endodontic procedure has been recommended as it may strengthen the root walls through the deposition of hard tissue and promote the development of a normal apical morphology. MTA was chosen to be placed over blood clot to provide excellent seal and it was considered the recommended material for regenerative procedures.The application of MTA over a blood clot was technically difficult, and condensation resulted in displacement of the material apically. Another important note was the prolonged setting time of MTA which resulted in postponing placement of composite restoration to next appointments and post-treatment tooth discoloration.

Biodentine has the same mechanical properties as human dentine, very low cytotoxicity and overcome clinical drawbacks of white MTA. It had better consistency and allow its condensation without any apical displacement. Biodentine sets within twelve minutes, which allow placement of composite restoration in the same appointment. Biodentine is tooth-colored and doesn't cause the discoloration resulted from the presence of the material at level of the orifice.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patients free from any systemic diseases that may hinder the normal healing process.
  • Age from 8-15 y
  • Tooth with immature root apex (apical opening greater than 1mm)
  • Traumatically or cariously exposed single rooted teeth
  • Non vital permanent anterior tooth with apical periodontitis/abscess
  • Pulp space not requiring post and core for final restoration.

Exclusion criteria

  • Patients having allergy to medicaments or antibiotics necessary to complete procedure.
  • Tooth with vital pulp or complete root formation.
  • Teeth with internal or external root resorption.
  • Un-cooperative patient

Treatment and study plan

Biodentine

Drug

a procedure used to regenerate a pulp-dentine complex that restores functional properties of this tissue, fosters continued root development for immature teeth, and prevents or resolves apical periodontitis.

Other names: Dentine substitute material

Mineral Trioxide Aggregate

Drug

a procedure used to regenerate a pulp-dentine complex that restores functional properties of this tissue, fosters continued root development for immature teeth, and prevents or resolves apical periodontitis.

Other names: MTA

Primary outcomes

  1. pain on biting

    Time frame: 3 months

    Binary outcome (Present or absent). Assessed by asking the patient

  2. pain on biting

    Time frame: 6 months

    Binary outcome (Present or absent). Assessed by asking the patient

  3. pain on biting

    Time frame: 9 months

    Binary outcome (Present or absent). Assessed by asking the patient

  4. pain on biting

    Time frame: 12 months

    Binary outcome (Present or absent). Assessed by asking the patient

Secondary outcomes

  1. pain on percussion

    Time frame: 3, 6, 9, 12 month

    Binary outcome (Present or absent). Assessed by tapping the tooth with the back of the mirror

  2. swelling

    Time frame: 3, 6, 9, 12 month

    Binary outcome (Present or absent). Assessed by visual examination of labial vestibule

  3. mobility

    Time frame: 3, 6, 9, 12 month

    Binary outcome (Present or absent). Assessed by applying pressure with the ends of 2 metal instruments

  4. Sinus or fistula

    Time frame: 3, 6, 9, 12 month

    Binary outcome (Present or absent). Assessed by visual examination of labial vestibule

  5. crown discoloration

    Time frame: 3, 6, 9, 12 month

    Binary outcome (Present or absent). Assessed by visual examination of the crown

  6. root lengthening

    Time frame: 3, 6, 9, 12 month

    Evaluated radiographically using DIGORA software.Unit of measurements were mm

  7. root lengthening

    Time frame: 3, 6, 9, 12 month

    Evaluated radiographically using DIGORA software.Unit of measurements were percent

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Clinical and Radiographic Evaluation of Biodentine and Mineral Trioxide Aggregate in Revascularization of Non Vital Immature Permanent Anterior Teeth (Randomized Clinical Study)

Important dates

Study start
2015
Primary completion
2017
Study completion
2018
First posted
Jul 18, 2018
Registry last updated
Jul 18, 2018

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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