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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01642693
Other study ID # 2006-007
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received July 13, 2012
Last updated July 16, 2012
Start date June 2006
Est. completion date May 2009

Study information

Verified date July 2012
Source Universidad de Antioquia
Contact n/a
Is FDA regulated No
Health authority Colombia: National Institutes of Health
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 34
Est. completion date May 2009
Est. primary completion date May 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 13 Years to 23 Years
Eligibility 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:

- Sistemics diseased

- Restoration, trauma in first premolars

- root uncompleted

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

Radiation:
Low 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
Other:
Simulated laser in teeth with intrusive movements
Simulated laser in teeth with intrusive movements for histological and root resorption changes

Locations

Country Name City State
Colombia Paula Villa M Medellin Antioquia

Sponsors (1)

Lead Sponsor Collaborator
Universidad de Antioquia

Country where clinical trial is conducted

Colombia, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 12 weeks Yes
Secondary Teeth with intrusive movements with no laser exposition Histological changes and root resorption were assesed in Teeth with intrusive movement with no laser exposition 12 weeks Yes
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