Pulp Revascularization Versus MTA Apexification

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

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-06

Study Completion Date

2015-12-02

Brief Summary

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This study compared the efficiency of pulp revascularization and MTA apexification in the treatment of patients with necrotic immature anterior teeth.

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Detailed Description

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the participants with 66 anterior necrotic immature teeth were randomly assigned into two equal groups with 33 teeth per each, according to regeneration and MTA apexification. At the first visit, all teeth were accessed and irrigated with NaOCl then a TAP was applied as intra-appointment intracanal medication. At the second visit, after removal of the medication with the irrigation, bleeding was initiated into the canal and isolated by the MTA in the orifice in the regeneration group. While in the Apexification group, the MTA was packed apically and all teeth were finally restored with resin composite restorations. The patients were recalled after 1, 3, 6, and 9 months for clinical and radiographic follow up.

Conditions

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Necrotic Pulp

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

participants are allocated at random to receive one of two interventions according to the research plan. In RCT the outcomes are measured, so it is considered a quantitative study . This trial conforms to the Consolidated Standard of Reporting Trials (CONSORT)statement.

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

For the allocation concealment mechanism, each of 66 papers (each paper was eight folded) numbered from 1 to 66 were, individually packed, in opaque envelopes. Each participant picked an envelope at the beginning of the second visit. The number in the envelope determined which procedure was to be performed for the patient. The partner was to decide the procedure for the operator according to that number.

Study Groups

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Revascularization

Blood clot initiation and grey MTA ( Mineral Tri-oxide Aggregate) cervically compacted.

Group Type EXPERIMENTAL

revascularization

Intervention Type PROCEDURE

a sterile sharp needle was used to irritate the apical tissue until bleeding occurred apically in the root canal space so as to create a biological scaffold for the regenerative process

Apexfication

Apexification using grey MTA apically compacted without mechanical preparation.

Group Type ACTIVE_COMPARATOR

Apexification

Intervention Type PROCEDURE

a 3-5 mm thickness of MTA using a hand plugger and was verified radiographically.

Interventions

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revascularization

a sterile sharp needle was used to irritate the apical tissue until bleeding occurred apically in the root canal space so as to create a biological scaffold for the regenerative process

Intervention Type PROCEDURE

Apexification

a 3-5 mm thickness of MTA using a hand plugger and was verified radiographically.

Intervention Type PROCEDURE

Other Intervention Names

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regeneration

Eligibility Criteria

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Inclusion Criteria

* Medically-free patients having immature necrotic anterior teeth (with or without apical periodontitis/abscess) even with previous intervention.

Exclusion Criteria

* History of allergy to any of the antibiotics in the tri-mix used in the study
* Patients with systemic diseases e.g. Diabetes mellitus, bleeding disorders,…
* Psychological disturbance
* External / internal root resorption or cystic lesion.

Minimum Eligible Age

7 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes