Evaluation of Retreatment of Failed Revasculatized Teeth by Revascularization

Evaluation of Retreatment of Failed Revasculatized Teeth by Revascularization. Randomized Clinical Trial

Study will include 30 participants with failed revascularized young permenant teeth that will be retreated by revascularization and evaluated for success through 2 years

Study Overview

• Status: Not yet recruiting
• Conditions: Revascularization
• Intervention / Treatment: Other: Revascularization

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 10 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• central and lateral immature incisors
• child from 8- 10 years old
• healthy chidren
• failed revascularization

Exclusion Criteria:

• medically compromised children
• mentally compromised children

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Revasularization; Revascularization of failed previously revascularized younge permenant inciors	Other: Revascularization; Regain pulp vascularity for young permenant teeth

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Root completion	Continue root maturation by radiographic assessment according to cvek classification ( increase root length)	2 years
Increase dentine thickness	Increase dentine thickness as response to new formed pulp like tissues	2 years
Lesion healing	Resolvation of periapical lesion through new bone formation, intact lamina dura, abscence of periapical radiolucency	2 years

Collaborators and Investigators

• Sponsor: Minia University

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2021
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): January 1, 2024

Study Registration Dates

• First Submitted: October 28, 2021
• First Submitted That Met QC Criteria: December 6, 2021
• First Posted (Actual): December 7, 2021

Study Record Updates

• Last Update Posted (Actual): December 7, 2021
• Last Update Submitted That Met QC Criteria: December 6, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 801

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No