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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03589560
Enrollment
26
Registered
2018-07-18
Start date
2015-01-15
Completion date
2018-01-15
Last updated
2018-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulp Necrosis

Keywords

revascularization, necrotic, immature, coronal plug

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

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.

Interventions

DRUGBiodentine

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.

DRUGMineral 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.

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
8 Years to 15 Years
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

Design outcomes

Primary

MeasureTime frameDescription
pain on biting3 monthsBinary outcome (Present or absent). Assessed by asking the patient

Secondary

MeasureTime frameDescription
swelling3, 6, 9, 12 monthBinary outcome (Present or absent). Assessed by visual examination of labial vestibule
mobility3, 6, 9, 12 monthBinary outcome (Present or absent). Assessed by applying pressure with the ends of 2 metal instruments
pain on percussion3, 6, 9, 12 monthBinary outcome (Present or absent). Assessed by tapping the tooth with the back of the mirror
crown discoloration3, 6, 9, 12 monthBinary outcome (Present or absent). Assessed by visual examination of the crown
root lengthening3, 6, 9, 12 monthEvaluated radiographically using DIGORA software.Unit of measurements were mm
Sinus or fistula3, 6, 9, 12 monthBinary outcome (Present or absent). Assessed by visual examination of labial vestibule

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026