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)

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

Study Overview

• Status: Completed
• Conditions: Pulp Necrosis
• Intervention / Treatment: Drug: Biodentine; Drug: Mineral Trioxide Aggregate

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 Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 13 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pain on biting	Binary outcome (Present or absent). Assessed by asking the patient	3 months
pain on biting	Binary outcome (Present or absent). Assessed by asking the patient	6 months
pain on biting	Binary outcome (Present or absent). Assessed by asking the patient	9 months
pain on biting	Binary outcome (Present or absent). Assessed by asking the patient	12 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Director: Randa Youssef, PHD, Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2015
• Primary Completion (Actual): August 15, 2017
• Study Completion (Actual): January 15, 2018

Study Registration Dates

• First Submitted: June 24, 2018
• First Submitted That Met QC Criteria: July 5, 2018
• First Posted (Actual): July 18, 2018

Study Record Updates

• Last Update Posted (Actual): July 18, 2018
• Last Update Submitted That Met QC Criteria: July 5, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: revascularization; necrotic; immature; coronal plug
• Additional Relevant MeSH Terms: Pathologic Processes; Stomatognathic Diseases; Tooth Diseases; Dental Pulp Diseases; Necrosis; Dental Pulp Necrosis
• Other Study ID Numbers: pulp revascularization

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No