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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03813433
Enrollment
24
Registered
2019-01-23
Start date
2023-06-30
Completion date
2024-11-30
Last updated
2022-07-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulp Necrosis

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

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

Interventions

OTHERRevascularization

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

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
8 Years to 14 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
discoloration1 monthAsking patient question (Binary:present or absent)
dicoloration6 monthsAsking patient question (Binary:present or absent)

Secondary

MeasureTime frameDescription
Pain on percussion1,3, 6, 9 and 12 monthsAssessed by back of the mirror (Binary: present or absent)
Swelling1,3, 6, 9 and 12 monthsassessed by visual examination (Binary:present or absent)
post operative pain1,3, 6, 9 and 12 monthsasking the patient (Binary: present or Absent)
Root lengthening6 and 12 monthsassessed radiographically (DIGORA® for Windows software)
Sinus or fistula1,3, 6, 9 and 12 monthsassessed by visual examination (Binary:present or absent)
color stability1,3, 6, 9 and 12 monthsOperator and supervisor evaluation (Using shade guide)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026