Root ResorptionPhase 1/2NCT00423956
Repair of Orthodontically-induced Tooth Root Resorption by Ultrasound
A Phase 1/2 study testing Repairing Induced tooth root resorption by ultrasound in people with Root Resorption, run by University of Alberta at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 28 yearsHealthy volunteers can take part
- Conditions the study is for
- Root Resorption
- What is being tested?
- Repairing Induced tooth root resorption by ultrasound
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2007to Dec 2015
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 28 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- Patients with incomplete experimental premolars' apices.
- 2- Any patient with experimental premolars that have a history of trauma/caries or root canal therapy.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
University of Alberta, Graduate Orthodontic program
Edmonton, Alberta, T6G 2N8
Dr. Tarek H El-Bialy, PhD, 780-492-2751, telbialy@ualberta.ca
About this study
Official title: Repair of Orthodontically-induced Tooth Root Resorption by Ultrasound in Human Subjects
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.
Read the 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
- Conditions
- Root Resorption
- Being tested
- Repairing Induced tooth root resorption by ultrasound
- Keywords
- Teeth root resorption, ultrasound, therapy
- Medical subject headings
- Root Resorption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repairing Induced tooth root resorption by ultrasoundProcedure or surgery
Repairing Induced tooth root resorption by ultrasound
| Study group | Role | What they receive |
|---|---|---|
| Sham Comparator | Sham comparator | One side is experimental and the opposite side is Sham control. Receives: Procedure: Repairing Induced tooth root resorption by ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the effect of LIPUS on OITRR
Measured: Four weeks
Teeth Root length
Measured: four weeks
Root resorption lacunae number and volume
Measured: Four weeks
Secondary outcomes (2)
Study the effect of LIPUS on alveolar bone remodeling
Measured: Four weeks
Rate of tooth movement
Teeth position before and after treatment will be measured to evaluate the possible effect of ultrasound on tooth movement.
Measured: Rate of tooth movement at the time of extraction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2007 (estimated)
- Study startJan 2007
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Root ResorptionStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tarek El-Bialy, University of Alberta
- Investigators
- Dr. Tarek H El-Bialy, PhD, Study chair, University of Alberta, Edmonton, AB, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00423956
- Sponsor's protocol ID
- 6203
- Status last verified
- Jan 2013
- First submitted
- 16 Jan 2007
- Last updated
- 23 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repair of Orthodontically-induced Tooth Root Resorption by Ultrasound in Human Subjects
- ClinicalTrials.gov ID
- NCT00423956
- Acronym / sponsor ID
- 6203
- Conditions
- Root Resorption
- Keywords
- Teeth root resorption, ultrasound, therapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 18 Jan 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sham Comparator | Sham comparator | Procedure: Repairing Induced tooth root resorption by ultrasoundOne side is experimental and the opposite side is Sham control. |
Who may qualify
- Ages
- 12 to 28 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- Patients with incomplete experimental premolars' apices.
- 2- Any patient with experimental premolars that have a history of trauma/caries or root canal therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Repairing Induced tooth root resorption by ultrasoundRepairing Induced tooth root resorption by ultrasound | Procedure or surgery | Sham Comparator |
Primary outcome
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
2 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Tarek H El-Bialy, PhD study chair
University of Alberta, Edmonton, AB, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Repairing Induced tooth root resorption by ultrasound in people with Root Resorption, run by University of Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr. Tarek H El-Bialy, PhD (1-780-492-2751, telbialy@ualberta.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the effect of LIPUS on OITRR (time frame: Four weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2013.