NCT01799187

Brief Summary

Revascularization is an alternative new treatment of immature permanent teeth with necrotic pulp nowadays while apexification is the traditional therapy. The investigators suppose that revascularization is superior to apexification at developing the root of immature permanent teeth and reducing the risk of root fracture,and the research is designed.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
190

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 24, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 26, 2013

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

July 22, 2014

Status Verified

July 1, 2014

Enrollment Period

3 years

First QC Date

February 24, 2013

Last Update Submit

July 19, 2014

Conditions

Keywords

Immature Permanent Teeth

Outcome Measures

Primary Outcomes (1)

  • Evidence of lesion healing confirmed by cone beam computed tomography

    one year

Study Arms (2)

revascularization

EXPERIMENTAL

revascularization is is an alternative new treatment of immature permanent teeth with necrotic pulp. The use of triple antibiotic paste is followed by Induction of bleeding from the apical root during this intervention.

Procedure: revascularization

apexification

ACTIVE COMPARATOR

apexification is a traditional therapy of immature permanent teeth with necrotic pulp.calcium hydroxide is served as medication to induce the developing of root .

Procedure: apexification

Interventions

revascularization include 3 steps: root disinfected,induction of bleeding and revascularization include 3 steps: root disinfected,induction of bleeding and sealing

revascularization
apexificationPROCEDURE

apexification uses calcium hydroxide as root medication

apexification

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • clinical diagnosis of periapical periodontitis
  • must be immature permanent teeth
  • must be local Guangzhou

You may not qualify if:

  • blood disease
  • residual root that is advised to extract
  • serious periodontitis
  • women in pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guanghua hospital of stomotology,Sun Yat-sen University

Guangzhou, Guangdong, 510055, China

RECRUITING

Related Publications (1)

  • Jung IY, Lee SJ, Hargreaves KM. Biologically based treatment of immature permanent teeth with pulpal necrosis: a case series. J Endod. 2008 Jul;34(7):876-87. doi: 10.1016/j.joen.2008.03.023. Epub 2008 May 16.

    PMID: 18571000BACKGROUND

MeSH Terms

Conditions

Periapical Periodontitis

Interventions

Apexification

Condition Hierarchy (Ancestors)

Periapical DiseasesJaw DiseasesStomatognathic DiseasesPeriodontal DiseasesMouth DiseasesPeriodontitis

Intervention Hierarchy (Ancestors)

Root Canal TherapyEndodonticsDentistry

Study Officials

  • ling j qi, PhD

    Guanghua hospital of stomotology,Sun Yat-sen University

    STUDY CHAIR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dean, professor

Study Record Dates

First Submitted

February 24, 2013

First Posted

February 26, 2013

Study Start

July 1, 2012

Primary Completion

July 1, 2015

Study Completion

July 1, 2021

Last Updated

July 22, 2014

Record last verified: 2014-07

Locations