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

Sponsor
Cairo University (Other)
Overall Status
Completed
CT.gov ID
NCT03589560
Collaborator
(none)
26
2
36

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
N/A

Detailed Description

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
26 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Clinical and Radiographic Evaluation of Biodentine and Mineral Trioxide Aggregate in Revascularization of Non Vital Immature Permanent Anterior Teeth (Randomized Clinical Study)
Actual Study Start Date :
Jan 15, 2015
Actual Primary Completion Date :
Aug 15, 2017
Actual Study Completion Date :
Jan 15, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Biodentine

3-4 mm of Biodentine (Septodont, St. Maur-des-Fosses, France) was applied over the clot carefully in group I by using amalgam carrier. material was packed lightly with a moistened cotton pellet and Periapical radiograph was taken to confirm coronal seal in the second visit of dental pulp revascularization.

Drug: Biodentine
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
  • Active Comparator: Mineral Trioxide Aggregate

    3-4 mm of white Mineral Trioxide Aggregate (Angelus, Londrina, Brazil) was applied over the clot in group II by using amalgam carrier. material was packed lightly with a moistened cotton pellet and Periapical radiograph was taken to confirm coronal seal in the second visit of dental pulp revascularization.

    Drug: Mineral Trioxide Aggregate
    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
  • Outcome Measures

    Primary Outcome Measures

    1. pain on biting [3 months]

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

    2. pain on biting [6 months]

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

    3. pain on biting [9 months]

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

    4. pain on biting [12 months]

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

    Secondary Outcome Measures

    1. pain on percussion [3, 6, 9, 12 month]

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

    2. swelling [3, 6, 9, 12 month]

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

    3. mobility [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 [3, 6, 9, 12 month]

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

    5. crown discoloration [3, 6, 9, 12 month]

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

    6. root lengthening [3, 6, 9, 12 month]

      Evaluated radiographically using DIGORA software.Unit of measurements were mm

    7. root lengthening [3, 6, 9, 12 month]

      Evaluated radiographically using DIGORA software.Unit of measurements were percent

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    8 Years to 15 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Cairo University

    Investigators

    • Study Director: Randa Youssef, PHD, Cairo University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mariam Mohsen Aly, Assistant Lecturer of Pediatric Dentistry and Dental public health, Faculty of Dentistry, Cairo University, Egypt., Cairo University
    ClinicalTrials.gov Identifier:
    NCT03589560
    Other Study ID Numbers:
    • pulp revascularization
    First Posted:
    Jul 18, 2018
    Last Update Posted:
    Jul 18, 2018
    Last Verified:
    Jul 1, 2018
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Mariam Mohsen Aly, Assistant Lecturer of Pediatric Dentistry and Dental public health, Faculty of Dentistry, Cairo University, Egypt., Cairo University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 18, 2018