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Clinical & Radiographic Evaluation of Neo MTA Versus White MTA in Revascularization of Non-Vital Immature Permanent Teeth

Primary Purpose

Nonvital Tooth

Status
Unknown status
Phase
Early Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
NeoMTA nusmile
White MTA
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nonvital Tooth focused on measuring pulp revascularization, endodontic regeneration, NeoMTA

Eligibility Criteria

7 Years - 15 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age of patients: 7-15years old.
  • Free from any systemic diseases that may affect the normal healing process.
  • Tooth with immature root apex.
  • Traumatically or cariously exposed non vital permanent anterior tooth.
  • 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 procedure.
  • Tooth with vital pulp or complete root formation.
  • Teeth with internal or external root resorption.
  • Un-cooperative patients.
  • Luxative injuries.
  • Teeth with a root fracture
  • Alveolar fracture
  • Subjects with chronic systemic illness.
  • Subjects with poor oral hygiene.
  • Compromised remaining tooth structure as teeth with extensive loss of coronal tissue will require restoration with a post that will occupy the space required for blood clot formation.

Sites / Locations

  • Faculty of Oral & Dental Medicine Cairo UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

NeoMTA (intervention group)

White MTA (Control group)

Arm Description

Revascularization with NeoMTA as coronal plug.

Revascularization with Conventional white mineral trioxide aggregate (White MTA) as coronal plug.

Outcomes

Primary Outcome Measures

Discoloration/ Staining potential
Using spectrophotometer by operator

Secondary Outcome Measures

Pain on biting
Verbal questioning of the patient
Pain on percussion
Using back of the mirror
Sinus or fistula, recurrent swelling
Visual examination by operator
Root lengthening
Radiographic Digora image analysis software i.e. Digora for windows software DFW

Full Information

First Posted
May 22, 2018
Last Updated
February 19, 2020
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT03545139
Brief Title
Clinical & Radiographic Evaluation of Neo MTA Versus White MTA in Revascularization of Non-Vital Immature Permanent Teeth
Official Title
Clinical and Radiographic Evaluation of Neo MTA Versus Conventional White MTA in Revascularization of Non-Vital Immature Permanent Anterior Teeth: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2019 (Actual)
Primary Completion Date
September 2020 (Anticipated)
Study Completion Date
September 2021 (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
Product Manufactured in and Exported from the U.S.
Yes

5. Study Description

Brief Summary
To evaluate and compare the degree of tooth discoloration in tooth crowns induced by Neo MTA versus white MTA over time. Evaluation of the effectiveness of Neo MTA as coronal plug in revascularization of immature teeth with necrotic pulp.
Detailed Description
The new formulation of MTA (NeoMTA) does not contain bismuth oxide, will be used in revascularization of nonvital immature permanent anterior teeth. to evaluate the effectiveness of Neo MTA as coronal plug and compare the degree of tooth discoloration in tooth crowns induced by Neo MTA versus white MTA over time.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nonvital Tooth
Keywords
pulp revascularization, endodontic regeneration, NeoMTA

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
NeoMTA (intervention group)
Arm Type
Experimental
Arm Description
Revascularization with NeoMTA as coronal plug.
Arm Title
White MTA (Control group)
Arm Type
Active Comparator
Arm Description
Revascularization with Conventional white mineral trioxide aggregate (White MTA) as coronal plug.
Intervention Type
Biological
Intervention Name(s)
NeoMTA nusmile
Intervention Description
A new formulation of MTA was developed in which bismuth oxide was omitted.
Intervention Type
Biological
Intervention Name(s)
White MTA
Intervention Description
Revascularization with Conventional white mineral trioxide aggregate as coronal plug.
Primary Outcome Measure Information:
Title
Discoloration/ Staining potential
Description
Using spectrophotometer by operator
Time Frame
9 month
Secondary Outcome Measure Information:
Title
Pain on biting
Description
Verbal questioning of the patient
Time Frame
9 month
Title
Pain on percussion
Description
Using back of the mirror
Time Frame
9 month
Title
Sinus or fistula, recurrent swelling
Description
Visual examination by operator
Time Frame
9 month
Title
Root lengthening
Description
Radiographic Digora image analysis software i.e. Digora for windows software DFW
Time Frame
9 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age of patients: 7-15years old. Free from any systemic diseases that may affect the normal healing process. Tooth with immature root apex. Traumatically or cariously exposed non vital permanent anterior tooth. 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 procedure. Tooth with vital pulp or complete root formation. Teeth with internal or external root resorption. Un-cooperative patients. Luxative injuries. Teeth with a root fracture Alveolar fracture Subjects with chronic systemic illness. Subjects with poor oral hygiene. Compromised remaining tooth structure as teeth with extensive loss of coronal tissue will require restoration with a post that will occupy the space required for blood clot formation.
Facility Information:
Facility Name
Faculty of Oral & Dental Medicine Cairo University
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hala Tawfik
Phone
01202555598
Email
hallatawfeek@hotmail.com

12. IPD Sharing Statement

Learn more about this trial

Clinical & Radiographic Evaluation of Neo MTA Versus White MTA in Revascularization of Non-Vital Immature Permanent Teeth

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