NCT03083015

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2012

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 6, 2012

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 2, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 2, 2015

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

March 7, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 17, 2017

Completed
Last Updated

March 21, 2017

Status Verified

March 1, 2017

Enrollment Period

3 years

First QC Date

March 7, 2017

Last Update Submit

March 19, 2017

Conditions

Necrotic Pulp

Keywords

regeneration, MTA apexification and TAPrevascularization

Outcome Measures

Primary Outcomes (1)

  • Pain intensity measures

    self reported pain intesity at 4, 12, 24, and 48 hours.(0= no pain and 100=worst pain) with a scale from 0 to 100 after the two visits.

    2 days

Secondary Outcomes (4)

  • Resolution of periapical pathosis

    9 months

  • Amount of radiographic increase in root length:

    baseline and 9 months

  • Amount of radiographic increase in the root dentinal wall thickness:

    baseline and 9 months

  • Decrease of apical diameter:

    baseline and 9 months

Study Arms (2)

Revascularization

EXPERIMENTAL

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

Procedure: revascularization

Apexfication

ACTIVE COMPARATOR

Apexification using grey MTA apically compacted without mechanical preparation.

Procedure: Apexification

Interventions

revascularizationPROCEDURE

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

Also known as: regeneration
Revascularization
ApexificationPROCEDURE

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

Apexfication

Eligibility Criteria

Age7 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Saoud TM, Zaazou A, Nabil A, Moussa S, Lin LM, Gibbs JL. Clinical and radiographic outcomes of traumatized immature permanent necrotic teeth after revascularization/revitalization therapy. J Endod. 2014 Dec;40(12):1946-52. doi: 10.1016/j.joen.2014.08.023. Epub 2014 Oct 16.

    PMID: 25443280RESULT

  • Alobaid AS, Cortes LM, Lo J, Nguyen TT, Albert J, Abu-Melha AS, Lin LM, Gibbs JL. Radiographic and clinical outcomes of the treatment of immature permanent teeth by revascularization or apexification: a pilot retrospective cohort study. J Endod. 2014 Aug;40(8):1063-70. doi: 10.1016/j.joen.2014.02.016. Epub 2014 Jun 13.

    PMID: 25069909RESULT

Related Links

MeSH Terms

Conditions

Dental Pulp Necrosis

Interventions

RegenerationApexification

Condition Hierarchy (Ancestors)

Dental Pulp DiseasesTooth DiseasesStomatognathic DiseasesNecrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biological PhenomenaRoot Canal TherapyEndodonticsDentistry

Study Officials

  • ahmed alkhadem, lecturer

    evidence based center, Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dentist at ministry of health

Study Record Dates

First Submitted

March 7, 2017

First Posted

March 17, 2017

Study Start

December 6, 2012

Primary Completion

December 2, 2015

Study Completion

December 2, 2015

Last Updated

March 21, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share