Regeneration of Immature Teeth. Case Series

February 21, 2020 updated by: Jordan University of Science and Technology

The Regenerative Potential of Immature Necrotic Teeth With Apical Periodontitis Based on Clinical and Radiographic Assessments

This clinical study aims to investigate the predictability of revascularization procedure of immature necrotic human permanent teeth with apical periodontitis. The quality of root development (thickness and length) will be assessed radiographically.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

All teeth will be disinfected using either triple antibiotic paste (a mixture of metronidazole, ciprofloxacin and amoxicillin mixed with sterile glycole) or non setting calcium hydroxide applied to the pulp space with a sterile lentulospiral and then closed temporarily with a sterile sponge and temporary restoration for 2-3 weeks to allow disinfection of the canals teeth will be reentered under rubber dam isolation and all intracanal medicaments will be washed out from the canal using 10 ml of 2.5% sodium hypochlorite and 20 ml of Ethylene diamine tetra acetic acid (EDTA). Then, a sterile endodontic file will be inserted past the canal terminus into the periapical tissues to induce bleeding to fill the canal space as much as possible and subsequently sealed with a double coronal seal using bioceramic repair material and composite filling. All the teeth will be monitored clinically and radiographically on a biannual basis.

Study Type

Interventional

Enrollment (Anticipated)

40

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 Locations

  • Jordan
      • Irbid, Jordan
        • Dental health center

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 20 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Teeth diagnosed with necrotic pulp with/without evidence of apical periodontitis.
  2. An immature/open apex.
  3. Tooth does not need post and core restoration.
  4. Medically healthy patients with no known allergy to used materials.

Exclusion Criteria:

  1. Medically compromised patient,
  2. Teeth with periodontal involvement
  3. Teeth with vertical root fractures,
  4. Non-restorable teeth,

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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Triple paste and induced bleeding
The triple paste is a mixture of metronidazole, ciprofloxacin and minocycline mixed with sterile glycol will be used and next visit intracanal bleeding will be induced
Procedure: Triple paste and induced bleeding
Drug: Triple Paste metronidazole, ciprofloxacin and minocycline mixed with sterile glycol
triple paste of metronidazole, ciprofloxacin and minocycline mixed with sterile glycol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
complete healing
Time Frame: from start of intervention up to 100 months.
Assess clinically and radiographically absence of symptoms and signs. And evidence for continuation of root development
from start of intervention up to 100 months.

Collaborators and Investigators

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

Sponsor

Jordan University of Science and Technology

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 (ACTUAL)

June 28, 2010

Primary Completion (ANTICIPATED)

November 1, 2021

Study Completion (ANTICIPATED)

December 1, 2030

Study Registration Dates

First Submitted

April 15, 2018

First Submitted That Met QC Criteria

April 24, 2018

First Posted (ACTUAL)

April 25, 2018

Study Record Updates

Last Update Posted (ACTUAL)

February 25, 2020

Last Update Submitted That Met QC Criteria

February 21, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JordanUST1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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