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Research of Revascularization in Immature Teeth With Periapical Periodontitis

Primary Purpose

Periapical Periodontitis

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

revascularization

apexification

About this trial

This is an interventional treatment trial for Periapical Periodontitis focused on measuring Immature Permanent Teeth

Eligibility Criteria

6 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Guanghua hospital of stomotology,Sun Yat-sen UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

revascularization

apexification

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Evidence of lesion healing confirmed by cone beam computed tomography

Secondary Outcome Measures

Full Information

NCT ID

NCT01799187

First Posted

February 24, 2013

Last Updated

July 19, 2014

Sponsor

Junqi Ling

Collaborators

Sun Yat-sen University

1. Study Identification

Unique Protocol Identification Number

NCT01799187

Brief Title

Research of Revascularization in Immature Teeth With Periapical Periodontitis

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2014

Overall Recruitment Status

Unknown status

Study Start Date

July 2012 (undefined)

Primary Completion Date

July 2015 (Anticipated)

Study Completion Date

July 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Junqi Ling

Collaborators

Sun Yat-sen University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Periapical Periodontitis

Keywords

Immature Permanent Teeth

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

190 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

revascularization

Arm Type

Experimental

Arm Description

Arm Title

apexification

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

revascularization

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

apexification

Intervention Description

apexification uses calcium hydroxide as root medication

Primary Outcome Measure Information:

Title

Evidence of lesion healing confirmed by cone beam computed tomography

Time Frame

one year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ling J Qi, PhD

Phone

020-83863002

lingjq@mail.sysu.edu.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

ling j qi, PhD

Organizational Affiliation

Guanghua hospital of stomotology,Sun Yat-sen University

Official's Role

Study Chair

Facility Information:

Facility Name

Guanghua hospital of stomotology,Sun Yat-sen University

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510055

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

ling j q, PhD

Phone

020-83863002

lingjq@mail.sysu.edu.cn

12. IPD Sharing Statement

Citations:

PubMed Identifier

18571000

Citation

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.

Results Reference

background

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Research of Revascularization in Immature Teeth With Periapical Periodontitis

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