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

Early Phase 1

• Conditions: Nonvital Tooth
• Interventions: Biological: White MTA; Biological: NeoMTA nusmile

• Registration Number: NCT03545139
• Lead Sponsor: Cairo University

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.

Study Timeline

• Study First Submitted: 2018-05-22
• Study First Submitted QC: 2018-05-22
• Study First Posted: 2018-06-04
• Study Start: 2019-09-01
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-19
• Last Update Posted: 2020-02-20
• Primary Completion: 2020-09
• Study Completion: 2021-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
White MTA (Control group)	White MTA	Revascularization with Conventional white mineral trioxide aggregate (White MTA) as coronal plug.
NeoMTA (intervention group)	NeoMTA nusmile	Revascularization with NeoMTA as coronal plug.

Primary Outcome Measures

Name	Time	Method
Discoloration/ Staining potential	9 month	Using spectrophotometer by operator

Secondary Outcome Measures

Name	Time	Method
Pain on biting	9 month	Verbal questioning of the patient
Pain on percussion	9 month	Using back of the mirror
Sinus or fistula, recurrent swelling	9 month	Visual examination by operator
Root lengthening	9 month	Radiographic Digora image analysis software i.e. Digora for windows software DFW

Trial Locations

Locations (1)

Faculty of Oral & Dental Medicine Cairo University; 🇪🇬 Cairo, Egypt