Discoloration of Endosequence and Mineral Trioxde Aggregate in Revascularization of Necrotic Immature Permanent Teeth

Discoloration After Revascularization Using Calcium Phosphosilicate Based Bioceramic vs Mineral Trioxide Aggregate in Necrotic Immature Permanent Anterior Teeth: A Randomized Clinical Trial

the objective of this study is to evaluate post operative pain after using Endosequence versus Mineral Trioxide Aggregate as coronal plug material in revascularization of non vital immature anterior teeth

Study Overview

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

Detailed Description

The treatment of immature young permanent anterior teeth is challenging because in addition of the need of elimination of bacterial infection; the lack of natural apical constriction against which a suitable filling material can be placed is considered the main problem.

In the past many different treatments have been proposed for immature permanent teeth with necrotic pulps such as:Custom fitting of filling materials like gutta percha, Periapical surgeries, apexification. The disadvantages of these treatments are: the compromised Crown/root ratio, possibility of vertical fracture.

Pulp revascularization is dependent on the ability of residual pulp and apical and periodontal stem cells to differentiate. These cells have the ability to generate a highly vascularized and rich living tissue.

MTA was chosen as coronal seal to be placed over the blood clot due its a biocompatibility, bio-inductivity. However, the disadvantages of MTA are: discoloration of the coronal dentine when placed in the canal and the difficult handling properties.

Recently, a new bioceramic material has been introduced to the market, namely, EndoSequence which is bioactive, has antibacterial activity, less cytotoxic effect and similar antimicrobial properties, maintain color stability of the tooth when compared to MTA

• Study Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age of patient range from 8-14 y.
• Patients are free from any systemic diseases that may hinder the normal healing process.
• Non vital permanent anterior teeth with open apex.
• 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 the procedure.
• Tooth with vital pulp or complete root formation.
• Teeth with internal or external root resorption.
• Un-cooperative patients

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Enosequence; 3-4 mm of Endosequence will be applied over the blood clot in group I. Material will be packed using condenser with light pressure. Periapical radiograph will be taken to ensure coronal seal in the second visit of revascularization	Other: Revascularization; a procedure used to regenerate pulp dentin complex that restores the functional properties of this immature anterior teeth, prevent and resolves apical periodontitis; Other Names: pulp regeneration
Active Comparator: Mineral Trioxide Aggregate; 3-4 mm of Mineral Trioxide Aggregate will be applied over the blood clot in group I. Material will be packed using condenser with light pressure. Periapical radiograph will be taken to ensure coronal seal in the second visit of revascularization	Other: Revascularization; a procedure used to regenerate pulp dentin complex that restores the functional properties of this immature anterior teeth, prevent and resolves apical periodontitis; Other Names: pulp regeneration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
discoloration	Asking patient question (Binary:present or absent)	1 month
discoloration	Asking patient question (Binary:present or absent)	3 months
dicoloration	Asking patient question (Binary:present or absent)	6 months
discoloration	Asking patient question (Binary:present or absent)	9 months
discoloration	Asking patient question (Binary:present or absent)	12months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
post operative pain	asking the patient (Binary: present or Absent)	1,3, 6, 9 and 12 months
color stability	Operator and supervisor evaluation (Using shade guide)	1,3, 6, 9 and 12 months
Pain on percussion	Assessed by back of the mirror (Binary: present or absent)	1,3, 6, 9 and 12 months
Swelling	assessed by visual examination (Binary:present or absent)	1,3, 6, 9 and 12 months
Sinus or fistula	assessed by visual examination (Binary:present or absent)	1,3, 6, 9 and 12 months
Root lengthening	assessed radiographically (DIGORA® for Windows software)	6 and 12 months

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2023
• Primary Completion (Anticipated): November 1, 2023
• Study Completion (Anticipated): November 1, 2024

Study Registration Dates

• First Submitted: January 14, 2019
• First Submitted That Met QC Criteria: January 19, 2019
• First Posted (Actual): January 23, 2019

Study Record Updates

• Last Update Posted (Actual): July 19, 2022
• Last Update Submitted That Met QC Criteria: July 18, 2022
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Stomatognathic Diseases; Tooth Diseases; Dental Pulp Diseases; Necrosis; Dental Pulp Necrosis
• Other Study ID Numbers: pedodontic department cairo

Drug and device information, study documents

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