LaserPhase 1/2NCT01642693
Histological Change of The Dentinal-Pulp Complex and Root Resorption
A Phase 1/2 study testing Low power laser in teeth after intrusive movement and Simulated laser in teeth with intrusive movements in people with Laser and Intrusion, run by Universidad de Antioquia at 1 site in Colombia.
Trial summary
The purpose of the study is evaluate the histological changes of the dentinal-pulp complex and root resorption in maxillary premolars with intrusive orthodontic movement under a low power laser effects. Read more about this study
- Who is it for?
- Ages 13 to 23 yearsHealthy volunteers can take part
- What is being tested?
- Low power laser in teeth after intrusive movement and Simulated laser in teeth with intrusive movements
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteColombia
- Study dates
- Jun 2006to May 2009
- 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 13 to 23 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Patients with first premolar extraction indicated
- Patients with no sistemic diseases
- Healthy premolars with completed root and no trauma or restoration
Who cannot join
- Sistemics diseased
- Restoration, trauma in first premolars
- root uncompleted
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Histological Changes of The Dentinal-Pulp Complex and Root Resorption in Maxillary Premolars With Intrusive Orthodontic Movements Under a Low Power Laser Effect
The purpose of the study is evaluate the histological changes of the dentinal-pulp complex and root resorption in maxillary premolars with intrusive orthodontic movement under a low power laser effects.
Read the detailed description
Orthodontics movements can cause inflamatory changes in the pulp and external inflamatory root resorption, different methods have been suggested to control that changes as the use of the low power laser. The objective of this study is to evaluate the low power laser effect on the inflamatory pulpar change and inflamatory external root resorption in maxillary premolars with intrusive orthodontic movements of 4 ounces during 12 weeks. Total sample were 34 healthy teeth, 16 were used to evaluate the normal standar and 18 were divided in two groups, the experimental group with the low power laser effect had a dose of 18 joules after activations of the orthodontic intrusion and the control group had a simulated effect in the same orthodontic movement. Teeth were extacted after 12 weeks and histological changes were evaluated in the dentinal-pulp complex and the pesence of external inflamatory root resorption. Findins suggest that low power. Laser decreased the inflamatory changes of the dentinal - pulp complex and the severity of the external inflamatory root resorption.
- Conditions
- Laser, Intrusion, Histology, Resorption
- Being tested
- Low power laser in teeth after intrusive movement, Simulated laser in teeth with intrusive movements
- Keywords
- root resorption, low-power laser, orthodontic tooth movement, pulp changes
- Medical subject headings
- Root Resorption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low power laser in teeth after intrusive movementRadiation
Low power laser was aplied to premolar teeth under an intrusive movement to study histological changes and root resorption
Simulated laser in teeth with intrusive movementsOther
Simulated laser in teeth with intrusive movements for histological and root resorption changes
| Study group | Role | What they receive |
|---|---|---|
| Teeth with intrusive movement and low power laser | Experimental | Histological changes and root resorption were assesed in Teeth with intrusive movement after a low power laser application Receives: Radiation: Low power laser in teeth after intrusive movement |
| Teeth with intrusive movements with no laser | Experimental | Histological changes and root resorption in Teeth with intrusive movements with no laser Receives: Other: Simulated laser in teeth with intrusive movements |
What is being measured
The primary outcome is the main question the study is designed to answer.
Teeth with intrusive movement and low power laser
Histological changes and root resorption were assesed in Teeth with intrusive movement after a low power laser application
Measured: 12 weeks
Secondary outcomes (1)
Teeth with intrusive movements with no laser exposition
Histological changes and root resorption were assesed in Teeth with intrusive movement with no laser exposition
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2012 (estimated)
- Study startJun 2006
- Primary completionMay 2008
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LaserStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Antioquia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paula Villa M, Universidad de Antioquia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01642693
- Sponsor's protocol ID
- 2006-007
- Status last verified
- Jul 2012
- First submitted
- 13 Jul 2012
- Last updated
- 17 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Histological Changes of The Dentinal-Pulp Complex and Root Resorption in Maxillary Premolars With Intrusive Orthodontic Movements Under a Low Power Laser Effect
- ClinicalTrials.gov ID
- NCT01642693
- Acronym / sponsor ID
- 2006-007
- Conditions
- Laser, Intrusion, Histology, Resorption
- Keywords
- root resorption, low-power laser, orthodontic tooth movement, pulp changes
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Universidad de AntioquiaUniversity, hospital or other
- Study start
- Jun 2006
- Primary completion
- May 2008 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 17 Jul 2012 (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.
The purpose of the study is evaluate the histological changes of the dentinal-pulp complex and root resorption in maxillary premolars with intrusive orthodontic movement under a low power laser effects.
Detailed description
Orthodontics movements can cause inflamatory changes in the pulp and external inflamatory root resorption, different methods have been suggested to control that changes as the use of the low power laser. The objective of this study is to evaluate the low power laser effect on the inflamatory pulpar change and inflamatory external root resorption in maxillary premolars with intrusive orthodontic movements of 4 ounces during 12 weeks. Total sample were 34 healthy teeth, 16 were used to evaluate the normal standar and 18 were divided in two groups, the experimental group with the low power laser effect had a dose of 18 joules after activations of the orthodontic intrusion and the control group had a simulated effect in the same orthodontic movement. Teeth were extacted after 12 weeks and histological changes were evaluated in the dentinal-pulp complex and the pesence of external inflamatory root resorption. Findins suggest that low power. Laser decreased the inflamatory changes of the dentinal - pulp complex and the severity of the external inflamatory root resorption.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Teeth with intrusive movement and low power laser | Experimental | Radiation: Low power laser in teeth after intrusive movementHistological changes and root resorption were assesed in Teeth with intrusive movement after a low power laser application |
| Teeth with intrusive movements with no laser | Experimental | Other: Simulated laser in teeth with intrusive movementsHistological changes and root resorption in Teeth with intrusive movements with no laser |
Who may qualify
- Ages
- 13 to 23 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Patients with first premolar extraction indicated
- Patients with no sistemic diseases
- Healthy premolars with completed root and no trauma or restoration
Key exclusion criteria (3 listed)
- Sistemics diseased
- Restoration, trauma in first premolars
- root uncompleted
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 |
|---|---|---|
| Low power laser in teeth after intrusive movementLow power laser was aplied to premolar teeth under an intrusive movement to study histological changes and root resorption | Radiation | Teeth with intrusive movement and low power laser |
| Simulated laser in teeth with intrusive movementsSimulated laser in teeth with intrusive movements for histological and root resorption changes | Other | Teeth with intrusive movements with no laser |
Primary outcome
Teeth with intrusive movement and low power laser
Time frame: 12 weeks
Histological changes and root resorption were assesed in Teeth with intrusive movement after a low power laser application
1 secondary outcome
Teeth with intrusive movements with no laser exposition
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2012.
- Related InfoLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Low power laser in teeth after intrusive movement and Simulated laser in teeth with intrusive movements in people with Laser and Intrusion, run by Universidad de Antioquia at 1 site in Colombia.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 17 Jul 2012. 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 Colombia. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Teeth with intrusive movement and low power laser (time frame: 12 weeks). 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 17 Jul 2012.