Clinical trial NCT03813433: Discoloration of Endosequence and Mineral Trioxde Aggregate in Revascularization of Necrotic Immature Permanent Teeth
Official title: Discoloration After Revascularization Using Calcium Phosphosilicate Based Bioceramic vs Mineral Trioxide Aggregate in Necrotic Immature Permanent Anterior Teeth: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pulp Necrosis
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-01-23
Enrollment: 24
Sex: ALL
Minimum age (years): 8
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: discoloration
timeFrame: 1 month
measure: discoloration
timeFrame: 3 months
measure: dicoloration
timeFrame: 6 months
measure: discoloration
timeFrame: 9 months
measure: discoloration
timeFrame: 12months
Secondary outcomes:
measure: post operative pain
timeFrame: 1,3, 6, 9 and 12 months
measure: color stability
timeFrame: 1,3, 6, 9 and 12 months
measure: Pain on percussion
timeFrame: 1,3, 6, 9 and 12 months
measure: Swelling
timeFrame: 1,3, 6, 9 and 12 months
measure: Sinus or fistula
timeFrame: 1,3, 6, 9 and 12 months
measure: Root lengthening
timeFrame: 6 and 12 months
Other outcomes:
Locations:
Study officials:
References: