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

Pulp Necrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03589560
• Other study ID #: pulp revascularization
• Status: Completed
• Phase: N/A
• Start date: January 15, 2015
• Est. completion date: January 15, 2018

Study information

• Verified date: July 2018
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: January 15, 2018
• Est. primary completion date: August 15, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 15 Years

Eligibility

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

Related Conditions & MeSH terms

• Dental Pulp Necrosis
• Necrosis
• Pulp Necrosis

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain on biting	Binary outcome (Present or absent). Assessed by asking the patient	3 months
Primary	pain on biting	Binary outcome (Present or absent). Assessed by asking the patient	6 months
Primary	pain on biting	Binary outcome (Present or absent). Assessed by asking the patient	9 months
Primary	pain on biting	Binary outcome (Present or absent). Assessed by asking the patient	12 months
Secondary	pain on percussion	Binary outcome (Present or absent). Assessed by tapping the tooth with the back of the mirror	3, 6, 9, 12 month
Secondary	swelling	Binary outcome (Present or absent). Assessed by visual examination of labial vestibule	3, 6, 9, 12 month
Secondary	mobility	Binary outcome (Present or absent). Assessed by applying pressure with the ends of 2 metal instruments	3, 6, 9, 12 month
Secondary	Sinus or fistula	Binary outcome (Present or absent). Assessed by visual examination of labial vestibule	3, 6, 9, 12 month
Secondary	crown discoloration	Binary outcome (Present or absent). Assessed by visual examination of the crown	3, 6, 9, 12 month
Secondary	root lengthening	Evaluated radiographically using DIGORA software.Unit of measurements were mm	3, 6, 9, 12 month
Secondary	root lengthening	Evaluated radiographically using DIGORA software.Unit of measurements were percent	3, 6, 9, 12 month