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CompletedNCT01642693Updated Jul 17, 2012

Histological Change of The Dentinal-Pulp Complex and Root Resorption

A Phase 1/2 interventional study of Low power laser in teeth after intrusive movement and Simulated laser in teeth with intrusive movements in Laser, Intrusion and Histology, sponsored by Universidad de Antioquia. Completed at 1 site in Colombia. Open to participants aged 13 Years to 23 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-07-17.

Sponsored by Universidad de Antioquia · Phase 1/2, Interventional, and Basic science

Phase
Phase 1/2
Study type
Interventional
Enrollment
34
Allocation
Non-randomized
Ages
13 Years to 23 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Laser
  • Intrusion
  • Histology
  • Resorption

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Keywords

  • root resorption
  • low-power laser
  • orthodontic tooth movement
  • pulp changes
03

In context

Root Resorption

43 studies on the registry are indexed under Root Resorption; 9 are open to participants now.

This study's enrollment of 34 is above the median of 29 across 36 interventional studies indexed under Root Resorption.

Browse Root Resorption studies →

Lead sponsor

Universidad de Antioquia is the lead sponsor of 80 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
13 Years to 23 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients with first premolar extraction indicated
  • Patients with no sistemic diseases
  • Healthy premolars with completed root and no trauma or restoration

Exclusion criteria

Exclusion Criteria:

  • Sistemics diseased
  • Restoration, trauma in first premolars
  • root uncompleted
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
34 participants (actual)

Study arms

  • Experimental
    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

    Radiation: Low power laser in teeth after intrusive movement

  • Experimental
    Teeth with intrusive movements with no laser

    Histological changes and root resorption in Teeth with intrusive movements with no laser

    Other: Simulated laser in teeth with intrusive movements

Interventions

  • RadiationLow power laser in teeth after intrusive movement

    Low power laser was aplied to premolar teeth under an intrusive movement to study histological changes and root resorption

  • OtherSimulated laser in teeth with intrusive movements

    Simulated laser in teeth with intrusive movements for histological and root resorption changes

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 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

    Time frame: 12 weeks

07

Study locations

1 site
  • Paula Villa M
    Medellin, Antioquia 00000, Colombia
08

References and documents

Related links

09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jun 2006, a primary completion of May 2008 and a completion of May 2009. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 13, 2012
First posted
Jul 17, 2012
Start
Jun 2006
Primary completionActual
May 2008
CompletionActual
May 2009
Last update
Jul 17, 2012
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 17, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01642693
Lead sponsor
Universidad de Antioquia
Responsible party
Paula Villa M (Partial time proffesor in Endodontics, Universidad de Antioquia) — Principal investigator
First posted
Jul 17, 2012
Start date
Jun 2006
Primary completion
May 2008
Completion
May 2009
Last update
Jul 17, 2012

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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