Discoloration of Endosequence and Mineral Trioxde Aggregate in Revascularization of Necrotic Immature Permanent Teeth
Primary Purpose
Pulp Necrosis
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Revascularization
Sponsored by
About this trial
This is an interventional treatment trial for Pulp Necrosis
Eligibility Criteria
Inclusion Criteria:
- Age of patient range from 8-14 y.
- Patients are free from any systemic diseases that may hinder the normal healing process.
- Non vital permanent anterior teeth with open apex.
- Pulp space not needed for post and core for final restoration.
- Compliant patient/parent.
Exclusion Criteria:
- Patients having allergy to medicaments and antibiotics necessary to complete the procedure.
- Tooth with vital pulp or complete root formation.
- Teeth with internal or external root resorption.
- Un-cooperative patients
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Enosequence
Mineral Trioxide Aggregate
Arm Description
3-4 mm of Endosequence will be applied over the blood clot in group I. Material will be packed using condenser with light pressure. Periapical radiograph will be taken to ensure coronal seal in the second visit of revascularization
3-4 mm of Mineral Trioxide Aggregate will be applied over the blood clot in group I. Material will be packed using condenser with light pressure. Periapical radiograph will be taken to ensure coronal seal in the second visit of revascularization
Outcomes
Primary Outcome Measures
discoloration
Asking patient question (Binary:present or absent)
discoloration
Asking patient question (Binary:present or absent)
dicoloration
Asking patient question (Binary:present or absent)
discoloration
Asking patient question (Binary:present or absent)
discoloration
Asking patient question (Binary:present or absent)
Secondary Outcome Measures
post operative pain
asking the patient (Binary: present or Absent)
color stability
Operator and supervisor evaluation (Using shade guide)
Pain on percussion
Assessed by back of the mirror (Binary: present or absent)
Swelling
assessed by visual examination (Binary:present or absent)
Sinus or fistula
assessed by visual examination (Binary:present or absent)
Root lengthening
assessed radiographically (DIGORA® for Windows software)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03813433
Brief Title
Discoloration of Endosequence and Mineral Trioxde Aggregate in Revascularization of Necrotic Immature Permanent Teeth
Official Title
Discoloration After Revascularization Using Calcium Phosphosilicate Based Bioceramic vs Mineral Trioxide Aggregate in Necrotic Immature Permanent Anterior Teeth: A Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 2023 (Anticipated)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
November 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
the objective of this study is to evaluate post operative pain after using Endosequence versus Mineral Trioxide Aggregate as coronal plug material in revascularization of non vital immature anterior teeth
Detailed Description
The treatment of immature young permanent anterior teeth is challenging because in addition of the need of elimination of bacterial infection; the lack of natural apical constriction against which a suitable filling material can be placed is considered the main problem.
In the past many different treatments have been proposed for immature permanent teeth with necrotic pulps such as:Custom fitting of filling materials like gutta percha, Periapical surgeries, apexification. The disadvantages of these treatments are: the compromised Crown/root ratio, possibility of vertical fracture.
Pulp revascularization is dependent on the ability of residual pulp and apical and periodontal stem cells to differentiate. These cells have the ability to generate a highly vascularized and rich living tissue.
MTA was chosen as coronal seal to be placed over the blood clot due its a biocompatibility, bio-inductivity. However, the disadvantages of MTA are: discoloration of the coronal dentine when placed in the canal and the difficult handling properties.
Recently, a new bioceramic material has been introduced to the market, namely, EndoSequence which is bioactive, has antibacterial activity, less cytotoxic effect and similar antimicrobial properties, maintain color stability of the tooth when compared to MTA
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulp Necrosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Enosequence
Arm Type
Experimental
Arm Description
3-4 mm of Endosequence will be applied over the blood clot in group I. Material will be packed using condenser with light pressure. Periapical radiograph will be taken to ensure coronal seal in the second visit of revascularization
Arm Title
Mineral Trioxide Aggregate
Arm Type
Active Comparator
Arm Description
3-4 mm of Mineral Trioxide Aggregate will be applied over the blood clot in group I. Material will be packed using condenser with light pressure. Periapical radiograph will be taken to ensure coronal seal in the second visit of revascularization
Intervention Type
Other
Intervention Name(s)
Revascularization
Other Intervention Name(s)
pulp regeneration
Intervention Description
a procedure used to regenerate pulp dentin complex that restores the functional properties of this immature anterior teeth, prevent and resolves apical periodontitis
Primary Outcome Measure Information:
Title
discoloration
Description
Asking patient question (Binary:present or absent)
Time Frame
1 month
Title
discoloration
Description
Asking patient question (Binary:present or absent)
Time Frame
3 months
Title
dicoloration
Description
Asking patient question (Binary:present or absent)
Time Frame
6 months
Title
discoloration
Description
Asking patient question (Binary:present or absent)
Time Frame
9 months
Title
discoloration
Description
Asking patient question (Binary:present or absent)
Time Frame
12months
Secondary Outcome Measure Information:
Title
post operative pain
Description
asking the patient (Binary: present or Absent)
Time Frame
1,3, 6, 9 and 12 months
Title
color stability
Description
Operator and supervisor evaluation (Using shade guide)
Time Frame
1,3, 6, 9 and 12 months
Title
Pain on percussion
Description
Assessed by back of the mirror (Binary: present or absent)
Time Frame
1,3, 6, 9 and 12 months
Title
Swelling
Description
assessed by visual examination (Binary:present or absent)
Time Frame
1,3, 6, 9 and 12 months
Title
Sinus or fistula
Description
assessed by visual examination (Binary:present or absent)
Time Frame
1,3, 6, 9 and 12 months
Title
Root lengthening
Description
assessed radiographically (DIGORA® for Windows software)
Time Frame
6 and 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age of patient range from 8-14 y.
Patients are free from any systemic diseases that may hinder the normal healing process.
Non vital permanent anterior teeth with open apex.
Pulp space not needed for post and core for final restoration.
Compliant patient/parent.
Exclusion Criteria:
Patients having allergy to medicaments and antibiotics necessary to complete the procedure.
Tooth with vital pulp or complete root formation.
Teeth with internal or external root resorption.
Un-cooperative patients
12. IPD Sharing Statement
Learn more about this trial
Discoloration of Endosequence and Mineral Trioxde Aggregate in Revascularization of Necrotic Immature Permanent Teeth
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