NCT01642693

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jun 2006

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

July 13, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 17, 2012

Completed
Last Updated

July 17, 2012

Status Verified

July 1, 2012

Enrollment Period

1.9 years

First QC Date

July 13, 2012

Last Update Submit

July 16, 2012

Conditions

LaserIntrusionHistologyResorption

Keywords

root resorptionlow-power laserorthodontic tooth movementpulp changes

Outcome Measures

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

    12 weeks

Secondary Outcomes (1)

  • Teeth with intrusive movements with no laser exposition

    12 weeks

Study Arms (2)

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

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

Other: Simulated laser in teeth with intrusive movements

Interventions

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

Teeth with intrusive movement and low power laser
Simulated laser in teeth with intrusive movementsOTHER

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

Teeth with intrusive movements with no laser

Eligibility Criteria

Age13 Years - 23 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Paula Villa M

Medellín, Antioquia, 00000, Colombia

Location

Related Links

MeSH Terms

Conditions

Root Resorption

Condition Hierarchy (Ancestors)

Tooth ResorptionTooth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Partial time proffesor in Endodontics

Study Record Dates

First Submitted

July 13, 2012

First Posted

July 17, 2012

Study Start

June 1, 2006

Primary Completion

May 1, 2008

Study Completion

May 1, 2009

Last Updated

July 17, 2012

Record last verified: 2012-07

Locations

CO(1)