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

Nonvital Tooth Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03545139
• Other study ID #: NeoMTA in Revascularization
• Status: Recruiting
• Phase: Early Phase 1
• Start date: September 1, 2019
• Est. completion date: September 2021

Study information

• Verified date: February 2020
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: September 2021
• Est. primary completion date: September 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 15 Years

Eligibility

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.

Related Conditions & MeSH terms

• Nonvital Tooth
• Tooth, Nonvital

Intervention

Biological:
• NeoMTA nusmile
A new formulation of MTA was developed in which bismuth oxide was omitted.
• White MTA
Revascularization with Conventional white mineral trioxide aggregate as coronal plug.

Locations

Country	Name	City	State
Egypt	Faculty of Oral & Dental Medicine Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Discoloration/ Staining potential	Using spectrophotometer by operator	9 month
Secondary	Pain on biting	Verbal questioning of the patient	9 month
Secondary	Pain on percussion	Using back of the mirror	9 month
Secondary	Sinus or fistula, recurrent swelling	Visual examination by operator	9 month
Secondary	Root lengthening	Radiographic Digora image analysis software i.e. Digora for windows software DFW	9 month