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

Not Applicable

Completed

• Conditions: Pulp Necrosis
• Interventions: Drug: Mineral Trioxide Aggregate; Drug: Biodentine

• Registration Number: NCT03589560
• Lead Sponsor: Cairo University

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.

Study Timeline

• Study Start: 2015-01-15
• Primary Completion: 2017-08-15
• Study Completion: 2018-01-15
• Study First Submitted: 2018-06-24
• Status Verified: 2018-07
• Study First Submitted QC: 2018-07-05
• Last Update Submitted: 2018-07-05
• Study First Posted: 2018-07-18
• Last Update Posted: 2018-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mineral Trioxide Aggregate	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.
Biodentine	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.

Primary Outcome Measures

Name	Time	Method
pain on biting	12 months	Binary outcome (Present or absent). Assessed by asking the patient

Secondary Outcome Measures

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