Repair of Orthodontically-induced Tooth Root Resorption by Ultrasound
Primary Purpose
Root Resorption
Status
Unknown status
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Repairing Induced tooth root resorption by ultrasound
Sponsored by
About this trial
This is an interventional prevention trial for Root Resorption focused on measuring Teeth root resorption, ultrasound, therapy
Eligibility Criteria
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.
Sites / Locations
- University of Alberta, Graduate Orthodontic programRecruiting
Arms of the Study
Arm 1
Arm Type
Sham Comparator
Arm Label
Sham Comparator
Arm Description
One side is experimental and the opposite side is Sham control.
Outcomes
Primary Outcome Measures
Evaluation of the effect of LIPUS on OITRR
Teeth Root length
Root resorption lacunae number and volume
Secondary Outcome Measures
Study the effect of LIPUS on alveolar bone remodeling
Rate of tooth movement
Teeth position before and after treatment will be measured to evaluate the possible effect of ultrasound on tooth movement.
Full Information
NCT ID
NCT00423956
First Posted
January 16, 2007
Last Updated
January 20, 2013
Sponsor
University of Alberta, Graduate Orthodontic Program
1. Study Identification
Unique Protocol Identification Number
NCT00423956
Brief Title
Repair of Orthodontically-induced Tooth Root Resorption by Ultrasound
Official Title
Repair of Orthodontically-induced Tooth Root Resorption by Ultrasound in Human Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Unknown status
Study Start Date
January 2007 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alberta, Graduate Orthodontic Program
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Root Resorption
Keywords
Teeth root resorption, ultrasound, therapy
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
72 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sham Comparator
Arm Type
Sham Comparator
Arm Description
One side is experimental and the opposite side is Sham control.
Intervention Type
Procedure
Intervention Name(s)
Repairing Induced tooth root resorption by ultrasound
Intervention Description
Repairing Induced tooth root resorption by ultrasound
Primary Outcome Measure Information:
Title
Evaluation of the effect of LIPUS on OITRR
Time Frame
Four weeks
Title
Teeth Root length
Time Frame
four weeks
Title
Root resorption lacunae number and volume
Time Frame
Four weeks
Secondary Outcome Measure Information:
Title
Study the effect of LIPUS on alveolar bone remodeling
Time Frame
Four weeks
Title
Rate of tooth movement
Description
Teeth position before and after treatment will be measured to evaluate the possible effect of ultrasound on tooth movement.
Time Frame
Rate of tooth movement at the time of extraction
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
28 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dr. Tarek H El-Bialy, PhD
Phone
1-780-492-2751
Email
telbialy@ualberta.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Tarek H El-Bialy, PhD
Organizational Affiliation
University of Alberta, Edmonton, AB, Canada
Official's Role
Study Chair
Facility Information:
Facility Name
University of Alberta, Graduate Orthodontic program
City
Edmonton,
State/Province
Alberta
ZIP/Postal Code
T6G 2N8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Tarek H El-Bialy, PhD
Phone
780-492-2751
Email
telbialy@ualberta.ca
12. IPD Sharing Statement
Learn more about this trial
Repair of Orthodontically-induced Tooth Root Resorption by Ultrasound
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