Clinical trial NCT03589560: Evaluation of Biodentine and Mineral Trioxide Aggregate in Revascularization of Non Vital Immature Anterior Teeth
Official title: Clinical and Radiographic Evaluation of Biodentine and Mineral Trioxide Aggregate in Revascularization of Non Vital Immature Permanent Anterior Teeth (Randomized Clinical Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulp Necrosis
Keywords: revascularization
necrotic
immature
coronal plug
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-07-18
Enrollment: 26
Sex: ALL
Minimum age (years): 8
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: pain on biting
timeFrame: 3 months
measure: pain on biting
timeFrame: 6 months
measure: pain on biting
timeFrame: 9 months
measure: pain on biting
timeFrame: 12 months
Secondary outcomes:
measure: pain on percussion
timeFrame: 3, 6, 9, 12 month
measure: swelling
timeFrame: 3, 6, 9, 12 month
measure: mobility
timeFrame: 3, 6, 9, 12 month
measure: Sinus or fistula
timeFrame: 3, 6, 9, 12 month
measure: crown discoloration
timeFrame: 3, 6, 9, 12 month
measure: root lengthening
timeFrame: 3, 6, 9, 12 month
measure: root lengthening
timeFrame: 3, 6, 9, 12 month
Other outcomes:
Locations:
Study officials:
affiliation: Cairo University
name: Randa Youssef, PHD
role: STUDY_DIRECTOR
References: