Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Repair of Orthodontically-induced Tooth Root Resorption by Ultrasound

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.
 
ClinicalTrials.gov Identifier: NCT00423956
Recruitment Status : Unknown
Verified January 2013 by Tarek El-Bialy, University of Alberta, Graduate Orthodontic Program.
Recruitment status was:  Recruiting
First Posted : January 18, 2007
Last Update Posted : January 23, 2013
Sponsor:
Information provided by (Responsible Party):
Tarek El-Bialy, University of Alberta, Graduate Orthodontic Program

Tracking Information
First Submitted Date  ICMJE January 16, 2007
First Posted Date  ICMJE January 18, 2007
Last Update Posted Date January 23, 2013
Study Start Date  ICMJE January 2007
Estimated Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 20, 2013)
  • Evaluation of the effect of LIPUS on OITRR [ Time Frame: Four weeks ]
  • Teeth Root length [ Time Frame: four weeks ]
  • Root resorption lacunae number and volume [ Time Frame: Four weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 16, 2007)
Evaluation of the effect of LIPUS on OITRR
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 20, 2013)
  • Study the effect of LIPUS on alveolar bone remodeling [ Time Frame: Four weeks ]
  • Rate of tooth movement [ Time Frame: Rate of tooth movement at the time of extraction ]
    Teeth position before and after treatment will be measured to evaluate the possible effect of ultrasound on tooth movement.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 16, 2007)
Study the effect of LIPUS on alveolar bone remodeling
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Repair of Orthodontically-induced Tooth Root Resorption by Ultrasound
Official Title  ICMJE Repair of Orthodontically-induced Tooth Root Resorption by Ultrasound in Human Subjects
Brief Summary

Tooth-root resorption, also known as shortening or erosion,(TRR) is one of the adverse outcomes of dental trauma, orthodontic tooth movement and dental replantation/transplantation. Orthodontically induced inflammatory root resorption (OIIRR) is somewhat different from other types of TRR. The treatment protocol of teeth diagnosed with severe OIIRR or other forms of TRR always involves root canal treatment or extraction of these teeth in severe cases and prosthetic replacement. Sometimes teeth with minor TRR may stay for an extended period of time with compromised bite functions. Although several trials have been proposed to minimize or prevent TRR or OIIRR, none is capable of being used in clinical situation to treat TRR or OIIRR in humans except for Low Intensity Pulsed Ultrasound (LIPUS). However, research examining the use of LIPUS to treat OIIRR has been limited to simple orthodontic tooth tipping. In reality, tooth movement is a combination of different types of tooth movements, namely tipping, bodily, rotational, torque, intrusion and extrusion tooth movements. However, the literature have pointed out that torque tooth movement, especially when the root apices are torques against cortical plates of bone produces the most dramatic type of tooth root resorption with poor prognosis. Our long-term goal is to develop a standard protocol for treating severe tooth root resorption with poor prognosis in humans, regardless of origin. Our preliminary data demonstrates that LIPUS can produce healing of OIIRR in humans after simple tipping movement, this was confirmed by an in-vitro study on isolated cementoblasts. The objective of the present proposal is to evaluate the effect of different treatment protocols of LIPUS on the healing process of orthodontically induced tooth-root resorption due to torque (Complex)type of tooth movement in humans.

The study Hypotheses are (I) LIPUS treatment for 20 minutes per day for 4 weeks will be effective in repairing OIIRR due to torque tooth movement.

(II) The stimulatory effect of LIPUS to repair OIIRR due to torque tooth movement than LIPUS treatment is dose and time dependent.

Detailed Description For each patient, specially designed springs will be used to achieve standard torque orthodontic tooth movement of the first premolars to induce OIIRR. The first molars will be stabilized, using a special appliance to help movement of the premolars. This type of appliance design has been used for many years in similar clinical trials by many researchers and has received wide acceptability without reported problems to the teeth during the experimental period. Ultrasound will be applied for twenty minutes per day, starting the day the springs are activated, for four weeks, using an ultrasound device (Exogen Inc., West Caldwell, NJ, USA). Only the first premolar will be receiving ultrasound. The patients will be instructed on how to have the ultrasound transducer. The non LIPUS treated premolars will be receiving sham transducers. A visual analogue scale will be provided to the patients to record any pain or discomfort that the patient might experience during or after application of ultrasound. It is expected that there will be no evidence of any deleterious effect on the intervening soft tissue as we did not informed with any discomfort experienced by the patients in our preliminary study. After four or eight weeks of LIPUS treatment, the springs will be removed, and the first premolars will be extracted, using a non-traumatic technique. The extracted teeth will be fixed, and studied by μ-CT then they will be processed to be analyzed histomorphometrically
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Root Resorption
Intervention  ICMJE Procedure: Repairing Induced tooth root resorption by ultrasound
Repairing Induced tooth root resorption by ultrasound
Study Arms  ICMJE Sham Comparator: Sham Comparator
One side is experimental and the opposite side is Sham control.
Intervention: Procedure: Repairing Induced tooth root resorption by ultrasound
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: January 16, 2007)
72
Original Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2015
Estimated Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • All the root apices of the experimental premolars should be completed.
  • All experimental premolars should be sound and have no history of trauma/caries or root canal therapy.

Exclusion Criteria:

  • Patients with incomplete experimental premolars' apices.
  • 2- Any patient with experimental premolars that have a history of trauma/caries or root canal therapy.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 28 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00423956
Other Study ID Numbers  ICMJE 6203
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Tarek El-Bialy, University of Alberta, Graduate Orthodontic Program
Study Sponsor  ICMJE University of Alberta, Graduate Orthodontic Program
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Dr. Tarek H El-Bialy, PhD University of Alberta, Edmonton, AB, Canada
PRS Account University of Alberta, Graduate Orthodontic Program
Verification Date January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP