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

Pulp Necrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03813433
• Other study ID #: pedodontic department cairo
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2023
• Est. completion date: November 2024

Study information

• Verified date: September 2021
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 24
• Est. completion date: November 2024
• Est. primary completion date: November 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 14 Years

Eligibility

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

Related Conditions & MeSH terms

• Dental Pulp Necrosis
• Necrosis
• Pulp Necrosis

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

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