Clinical & Radiographic Evaluation of Neo MTA Versus Whit... | NCT03545139

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

NCT03545139

Sponsor

Cairo University

Status

Unknown status

Last Update Posted

Feb 20, 2020Actual

Enrollment

30Estimated

Phase

Early Phase 1

Conditions

Nonvital Tooth

Interventions

NeoMTA nusmile
White MTA

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2019Actual

Primary Completion Date

Sep 2020Estimated

Completion Date

Sep 2021Estimated

First Submitted Date

May 22, 2018

First Submission Date that Met QC Criteria

May 22, 2018

First Posted Date

Jun 4, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 19, 2020

Last Update Posted Date

Feb 20, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Hala Ahmed Tawfik, Researcher assistant at orthodontic and pediatric dentistry department National Research centre, Cairo UniversityPrincipal Investigator

Lead Sponsor

Cairo UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
NeoMTA (intervention group)	Experimental	Revascularization with NeoMTA as coronal plug.	Biological: NeoMTA nusmile
White MTA (Control group)	Active Comparator	Revascularization with Conventional white mineral trioxide aggregate (White MTA) as coronal plug.	Biological: White MTA

Interventions

Name	Type	Description	Arm Group Labels	Other Names
NeoMTA nusmile	Biological	A new formulation of MTA was developed in which bismuth oxide was omitted.	NeoMTA (intervention group)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Discoloration/ Staining potential	Using spectrophotometer by operator	9 month

Secondary Outcomes

Measure	Description	Time Frame
Pain on biting	Verbal questioning of the patient	9 month
Pain on percussion	Using back of the mirror	9 month

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

7 Years

Maximum Age

15 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of Oral & Dental Medicine Cairo University	Recruiting	Cairo			Egypt

Condition Browse Module

MeSH Terms

ID	Term
D019553	Tooth, Nonvital

Ancestor Terms

ID	Term
D003788	Dental Pulp Diseases
D014076	Tooth Diseases
D009057	Stomatognathic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided