Regenerative Endodontic Treatment of Mature Necrotic Teeth With Apical Periodontitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-01

Study Completion Date

2023-06-01

Brief Summary

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The aim of this prospective, randomized, controlled double-blind study is to evaluate the effectiveness of biodentine compared with MTA used as pulp space barrier on discoloration of teeth after regenerative based non-obturation root canal treatment in mature single canal with pulp necrosis and apical periodontitis.

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Detailed Description

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• Regenerative endodontic treatment will be performed through two visits: First visit aims to clean and disinfect the tooth canal by copious irrigation with NaOCL and EDTA solution . At the end of first visit, canal will be dressed by CaOH as intracanal medicaments.

Second visit will be after two weeks. After removal of CaOH dressing by copius irrigation, evoking bleeding inside canal by over instrumentation. When blood become semi-coagulated, according to the random sequence number of the participants, either biodentine or white MTA will be placed as pulp space barrier.

At the end of treatment, the access cavity will be sealed with composite restoration.

Conditions

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Necrotic Pulp Apical Periodontitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Participants/ outcome assessor will be blinded

Study Groups

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Biodentine

Intervention group: application of biodentine as pulp space barrier during regenerative endodontic treatment.

Group Type EXPERIMENTAL

Biodentine

Intervention Type OTHER

Biodentine is calcium silicate based cement which is bioactive and inductive material. Biodentine will be applied as coronal plug material.

White MTA

Control group: application of White MTA as pulp space barrier during regenerative endodontic treatment.

Group Type ACTIVE_COMPARATOR

White MTA

Intervention Type OTHER

MTA is calcium silicate based cement which is bioactive and inductive material. MTA is used in most cases of regenerative endodontics and it will be applied as coronal plug material.

Interventions

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Biodentine

Biodentine is calcium silicate based cement which is bioactive and inductive material. Biodentine will be applied as coronal plug material.

Intervention Type OTHER

White MTA

MTA is calcium silicate based cement which is bioactive and inductive material. MTA is used in most cases of regenerative endodontics and it will be applied as coronal plug material.

Intervention Type OTHER

Other Intervention Names

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white mineral trioxide aggregate

Eligibility Criteria

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Inclusion Criteria

1. Tooth type: single-rooted teeth (anterior or premolar) encasing of one root canal with mature root (closed apex).
2. Negative response of pulp tissue to electrical or thermal pulp tester.
3. Widening in lamina dura or periapical radiolucency not more than 3 mm.

Exclusion Criteria

* 1\. Patients having significant systemic disorder or immunocompromised patients. 2. Teeth with generalized chronic periodontitis or have periodontal pocket larger than 3 mm.

3\. Teeth with developmental anomalies (i.e, dens invaginatusor a palatogingival groove).

4\. Teeth with previous root canal. 5. Teeth need to post and core as final restoration

Minimum Eligible Age

10 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No