Research of Revascularization in Immature Teeth With Periapical Periodontitis

Periapical Periodontitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01799187
• Other study ID #: 5010YT
• Secondary ID: jqling
• Status: Recruiting
• Phase: N/A
• First received: February 24, 2013
• Last updated: July 19, 2014
• Start date: July 2012
• Est. completion date: July 2021

Study information

• Verified date: July 2014
• Source: Sun Yat-sen University
• Contact: Ling J Qi, PhD
• Phone: 020-83863002
• Email: lingjq[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 190
• Est. completion date: July 2021
• Est. primary completion date: July 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Years to 18 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Periapical Periodontitis
• Periodontitis

Intervention

Procedure:
• revascularization
revascularization include 3 steps: root disinfected,induction of bleeding and revascularization include 3 steps: root disinfected,induction of bleeding and sealing
• apexification
apexification uses calcium hydroxide as root medication

Locations

Country	Name	City	State
China	Guanghua hospital of stomotology,Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Junqi Ling	Sun Yat-sen University

Country where clinical trial is conducted

China, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evidence of lesion healing confirmed by cone beam computed tomography		one year	No