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

NCT03545139 | Unknown Early Phase 1

• 1 other identifier: NeoMTA in Revascularization
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Nonvital Tooth

Keywords

pulp revascularization; endodontic regeneration; NeoMTA

Outcome Measures

Primary Outcomes (1)

• Discoloration/ Staining potential

  Using spectrophotometer by operator

  9 month

Secondary Outcomes (4)

• Pain on biting

  9 month

• Pain on percussion

  9 month

• Sinus or fistula, recurrent swelling

  9 month

• Root lengthening

  9 month

Study Arms (2)

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

NeoMTA nusmile BIOLOGICAL

A new formulation of MTA was developed in which bismuth oxide was omitted.

NeoMTA (intervention group)

White MTA BIOLOGICAL

Revascularization with Conventional white mineral trioxide aggregate as coronal plug.

White MTA (Control group)

Eligibility Criteria

• Age: 7 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Oral & Dental Medicine Cairo University

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Tooth, Nonvital

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher assistant at orthodontic and pediatric dentistry department National Research centre

Study Record Dates

• First Submitted: May 22, 2018
• First Posted: June 4, 2018
• Study Start: September 1, 2019
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2021
• Last Updated: February 20, 2020

Record last verified: 2020-02

Locations

EG (1)