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Research of Revascularization in Immature Teeth With Periapical Periodontitis

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ClinicalTrials.gov Identifier: NCT01799187
Recruitment Status : Recruiting
First Posted : February 26, 2013
Last Update Posted : July 22, 2014
Sponsor:
Collaborator:
Sun Yat-sen University
Information provided by (Responsible Party):
Junqi Ling, Sun Yat-sen University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Periapical Periodontitis Procedure: revascularization Procedure: apexification Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 190 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Randomized Controlled Research of Revascularization in Immature Permanent Teeth With Periapical Periodontitis
Study Start Date : July 2012
Estimated Primary Completion Date : July 2015
Estimated Study Completion Date : July 2021
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Evidence of lesion healing confirmed by cone beam computed tomography [ Time Frame: one year ]

Eligibility Criteria
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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01799187


Contacts
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Contact: Ling J Qi, PhD 020-83863002 lingjq@mail.sysu.edu.cn

Locations
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China, Guangdong
Guanghua hospital of stomotology,Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China, 510055
Contact: ling j q, PhD    020-83863002    lingjq@mail.sysu.edu.cn   
Sponsors and Collaborators
Junqi Ling
Sun Yat-sen University
Investigators
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Study Chair: ling j qi, PhD Guanghua hospital of stomotology,Sun Yat-sen University
More Information
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Publications:

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Responsible Party: Junqi Ling, Dean, professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT01799187    
Other Study ID Numbers: 5010YT
jqling ( Registry Identifier: Junqi Ling )
First Posted: February 26, 2013    Key Record Dates
Last Update Posted: July 22, 2014
Last Verified: July 2014
Keywords provided by Junqi Ling, Sun Yat-sen University:
Immature Permanent Teeth
Additional relevant MeSH terms:
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Periodontitis
Periapical Periodontitis
Periodontal Diseases
Mouth Diseases
 Stomatognathic Diseases
Periapical Diseases
Jaw Diseases