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

NCT03813433 | Unknown DMC

• 1 other identifier: pedodontic department cairo
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Pulp Necrosis

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (6)

• post operative pain

  1,3, 6, 9 and 12 months

• color stability

  1,3, 6, 9 and 12 months

• Pain on percussion

  1,3, 6, 9 and 12 months

• Swelling

  1,3, 6, 9 and 12 months

• Sinus or fistula

  1,3, 6, 9 and 12 months

Study Arms (2)

Enosequence

EXPERIMENTAL

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

Mineral Trioxide Aggregate

ACTIVE COMPARATOR

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

Interventions

Revascularization OTHER

a procedure used to regenerate pulp dentin complex that restores the functional properties of this immature anterior teeth, prevent and resolves apical periodontitis

Also known as: pulp regeneration

Enosequence; Mineral Trioxide Aggregate

Eligibility Criteria

• Age: 8 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Dental Pulp Necrosis

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assisstant lecturer

Study Record Dates

• First Submitted: January 14, 2019
• First Posted: January 23, 2019
• Study Start: June 1, 2023
• Primary Completion: November 1, 2023
• Study Completion: November 1, 2024
• Last Updated: July 19, 2022

Record last verified: 2021-09