- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03589560
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)
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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.
|
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:
|
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.
|
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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
pain on biting
Time Frame: 3 months
|
Binary outcome (Present or absent).
Assessed by asking the patient
|
3 months
|
pain on biting
Time Frame: 6 months
|
Binary outcome (Present or absent).
Assessed by asking the patient
|
6 months
|
pain on biting
Time Frame: 9 months
|
Binary outcome (Present or absent).
Assessed by asking the patient
|
9 months
|
pain on biting
Time Frame: 12 months
|
Binary outcome (Present or absent).
Assessed by asking the patient
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
pain on percussion
Time Frame: 3, 6, 9, 12 month
|
Binary outcome (Present or absent).
Assessed by tapping the tooth with the back of the mirror
|
3, 6, 9, 12 month
|
swelling
Time Frame: 3, 6, 9, 12 month
|
Binary outcome (Present or absent).
Assessed by visual examination of labial vestibule
|
3, 6, 9, 12 month
|
mobility
Time Frame: 3, 6, 9, 12 month
|
Binary outcome (Present or absent).
Assessed by applying pressure with the ends of 2 metal instruments
|
3, 6, 9, 12 month
|
Sinus or fistula
Time Frame: 3, 6, 9, 12 month
|
Binary outcome (Present or absent).
Assessed by visual examination of labial vestibule
|
3, 6, 9, 12 month
|
crown discoloration
Time Frame: 3, 6, 9, 12 month
|
Binary outcome (Present or absent).
Assessed by visual examination of the crown
|
3, 6, 9, 12 month
|
root lengthening
Time Frame: 3, 6, 9, 12 month
|
Evaluated radiographically using DIGORA software.Unit of measurements were mm
|
3, 6, 9, 12 month
|
root lengthening
Time Frame: 3, 6, 9, 12 month
|
Evaluated radiographically using DIGORA software.Unit of measurements were percent
|
3, 6, 9, 12 month
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Randa Youssef, PHD, Cairo University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- pulp revascularization
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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