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Regenerative Endodontic Treatment of Traumatised Teeth

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03045185
Recruitment Status : Completed
First Posted : February 7, 2017
Last Update Posted : February 8, 2017
Information provided by (Responsible Party):
Hani Nazzal, University of Leeds

Brief Summary:
Aim: The aim of this prospective study was to evaluate the treatment outcomes of regenerative endodontic technique (RET) for the management of traumatised non-vital immature teeth in children. Methodology: This study aims to recruit 25-30 healthy children with traumatised non-vital immature upper incisors to be treated with bi-antibiotic regenerative endodontic technique. Patients will be reviewed clinically at 3m,6m,9m,12m,2y,and 3 years and radiographically at 3m,9m, 2y,and 3 years. One operator will undertake all treatments, clinical reviews and standardised radiographic exposures. Radiographic analysis will be carried out by two calibrated experienced clinicians. Standardised photographs will be taken at 3m,12m,2y,and 3 years and crown colour changes will be assessed using a standardised validated methodology.

Condition or disease Intervention/treatment Phase
Tooth Injuries Endodontically Treated Teeth Procedure: RET using Ciprofloxacin 100mg, and Metronidazole 100mg. Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Prospective interventional uncontrolled trial
Masking: None (Open Label)
Masking Description: Single group so no masking
Primary Purpose: Treatment
Official Title: A Prospective Clinical Study of Regenerative Endodontic Treatment of Traumatised Non-vital Immature Teeth Using Bi-antibiotic Paste
Actual Study Start Date : January 1, 2013
Actual Primary Completion Date : January 1, 2015
Actual Study Completion Date : January 1, 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Treatment Group
RET using Ciprofloxacin 100mg, and Metronidazole 100mg.
Procedure: RET using Ciprofloxacin 100mg, and Metronidazole 100mg.

First Treatment Visit: Tooth isolation, access, pulp extirpation and root canal irrigation with 0.5% sodium hypochlorite. Canal negotiation, canal drying using paper points. Delivery of the Bi antibiotic paste (mixture of Bi antibiotic paste (Ciprofloxacin 100mg and Metronidazole 100mg with sterile water). Sealing tooth access with glass ionomer cement.

Second Treatment Visit: Tooth analgesia using plain local analgesics, isolatation and re-access as described above. Irrigation of root canal system using normal saline followed by paper point dying. Initiation of bleeding through insertion of a sterile 23-gauge needle with a length of 2 mm beyond the working length into the periapical tissues. Access sealed using Portland cement, followed by glass ionomer and then composite resin.

Primary Outcome Measures :
  1. Change in root length [ Time Frame: Month 3, Month 9, Year 2, and year 3. ]
    Root length from cement enamel junction to radiographic apex measured over time

  2. Change in root dentinal wall width [ Time Frame: Month 3, Month 9, Year 2, and year 3. ]
    Root dentinal width measured radiographically at 2/3 root length over time

  3. Change in apical foramen width [ Time Frame: Month 3, Month 9, Year 2, and year 3. ]
    Apical foramen width measured radiographically over time

  4. Change in periodontal healing [ Time Frame: Month 3, Month 6, Month 9, Year 2, and year 3. ]
    Absence of signs and symptoms of infection over time

Secondary Outcome Measures :
  1. Change in crown Colour [ Time Frame: Month 3,Month 12, year 2, and year 3. ]
    Crown colour change measured using CIELAB scores

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Ages Eligible for Study:   6 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Patients aged 6-16 years of age
  • Patients who are fit and healthy or with an ASA1 or ASA2 medical conditions
  • Patients with cooperation level that would allow treatment under local analgesia
  • Patients with a traumatised permanent incisors, canines or premolars having at least one of the following:

    • Necrotic or partially necrotic root canal systems.
    • Periapical periodontitis/abscess.
    • Sinus tract.
  • Patients with permanent incisors, canines or premolars that have incomplete root formation with open apices.

Exclusion Criteria:

  • Patient older than 16 year of age
  • Patients allergic to Ciprofloxacin, Metronidazole.
  • Patients with medical conditions and/or receiving medications that would affect patients' body's ability to heal such as diabetic patients or ability of the patients' blood to clot such as patients with Von Willebrand's disease.
  • Patients with risk of developing infective endocarditis or immune compromised patients.
  • Patients with non traumatised non-vital permanent incisors, canines or premolars where root development already deemed to be completed.
  • No concurrent signs of other pathological root resorption, such as replacement root resorption, which could otherwise affect the prognosis of the tooth.
  • Uncooperative patients.

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 identifier (NCT number): NCT03045185

Sponsors and Collaborators
University of Leeds
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Principal Investigator: Hani Nazzal, BDS, PhD University of Leeds, School of Dentistry, Paediatric Dentistry Department
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Responsible Party: Hani Nazzal, Dr, University of Leeds Identifier: NCT03045185    
Other Study ID Numbers: REC 12/YH0488
First Posted: February 7, 2017    Key Record Dates
Last Update Posted: February 8, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Not planning on IPD

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hani Nazzal, University of Leeds:
Non Vital teeth
Traumatised teeth
Immature teeth
Regenerative Endodontics
Additional relevant MeSH terms:
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Tooth, Nonvital
Tooth Injuries
Dental Pulp Diseases
Tooth Diseases
Stomatognathic Diseases
Wounds and Injuries
Anti-Infective Agents
Anti-Bacterial Agents
Antiprotozoal Agents
Antiparasitic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors