Research of Revascularization in Immature Teeth With Periapical Periodontitis

July 19, 2014 updated by: Junqi Ling

Randomized Controlled Research of Revascularization in Immature Permanent Teeth With Periapical Periodontitis

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The investigators design to collect a group of patients presenting immature permanent teeth with periapical periodontitis in certain criterion. The investigators will divide the patients into two groups randomly. One group will get treated with revascularization while the other with apexification. The investigators want to evaluate the short-term and long-term effects of the two groups to get a conclusion of the clinical value of revascularization.

Study Type

Interventional

Enrollment (Anticipated)

190

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510055
        • Recruiting
        • Guanghua hospital of stomotology,Sun Yat-sen University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: revascularization
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
revascularization include 3 steps: root disinfected,induction of bleeding and revascularization include 3 steps: root disinfected,induction of bleeding and sealing
ACTIVE_COMPARATOR: apexification
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
apexification uses calcium hydroxide as root medication

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evidence of lesion healing confirmed by cone beam computed tomography
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Junqi Ling

Collaborators

Sun Yat-sen University

Investigators

  • Study Chair: ling j qi, PhD, Guanghua hospital of stomotology,Sun Yat-sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (ANTICIPATED)

July 1, 2015

Study Completion (ANTICIPATED)

July 1, 2021

Study Registration Dates

First Submitted

February 24, 2013

First Submitted That Met QC Criteria

February 25, 2013

First Posted (ESTIMATE)

February 26, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

July 22, 2014

Last Update Submitted That Met QC Criteria

July 19, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5010YT
  • jqling (REGISTRY: Junqi Ling)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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