Periodontal Ligament Stress Level and Tooth Movement

NCT00099814 | Completed Phase 1

• 1 other identifier: GOP-UA-CT-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Orthodontic treatment requires application of force systems to individual teeth or groups of teeth, which results in a cellular response with periodontal ligament (PDL) and alveolar bone remodeling. The forces applied must be of sufficient magnitude and duration to exceed the normal physiologic threshold associated with daily oral function. Excessive force levels will result in areas of tissue necrosis with delayed tooth movement and increased risk of root resorption. Although orthodontic tooth movement is achieved in a large segment of the population, the optimum force level has not been defined. The optimum force for tooth movement depends on individual root geometry as well as biologic characteristics of surrounding tissue including bone density, periodontal thickness, and fluid dynamics. Because experimental and clinical techniques are generally limited to known complex force systems, biomechanical modeling has become a necessity. Such models must be validated with well-controlled clinical studies that evaluate orthodontic tooth movement over an extended distance. The ultimate goal would be development of a computer simulation model to predict tooth movement in the clinical setting. The primary objective of this study is to test controlled clinical data with a biomechanical model of the tooth and supporting tissues for distal movement of the human maxillary canine tooth (of known root geometry) in response to various 3D force systems that produce different levels of stress in the supporting tissues. Secondary objectives include evaluation of rate of bodily tooth canine movement with two known compressive stress levels (13 and 22 kPa), evaluation of three different reference systems to measure rate of tooth movement, and evaluation of an implant placed in the roof of the mouth (palatal implant) for orthodontic anchorage in adolescent patients. The rate of translation (bodily) tooth movement of the maxillary canine tooth will be significantly greater with 22kPa compared to 13kPa compressive stress applied to the periodontal ligament, and this difference can be predicted by appropriate mathematical/numerical models of the tooth and supporting tissues.

Conditions

Malocclusion, Angle Class III

Keywords

tooth movement; orthodontics; force; humans; clinical trial

Outcome Measures

Primary Outcomes (1)

• Rate of space closure

Interventions

Two different loop designs which deliver distinctive forces PROCEDURE

Eligibility Criteria

• Age: 12 Years - 16 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Female adolescent (12-16 years old) orthodontic patients requiring upper first premolars extractions for overjet reduction.
• Participants will be healthy and not taking any medications.
• All participants will have healthy periodontal tissues and good oral hygiene.

You may not qualify if:

• Patients with medical contraindication for placement of a palatal implant.
• All candidates who admit to tobacco utilization will be excluded.
• Patients requiring lower dental extractions will also be excluded.
• Pregnant patients or patients planning pregnancy will be excluded.

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

Orthodontic Clinic - Department of Dentistry - University of Alberta

Edmonton, Alberta, T6G 2N8, Canada

Location

MeSH Terms

Conditions

Malocclusion, Angle Class III

Condition Hierarchy (Ancestors)

Malocclusion; Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 21, 2004
• First Posted: December 21, 2004
• Study Start: March 1, 2004
• Primary Completion: November 1, 2005
• Study Completion: November 1, 2005
• Last Updated: November 5, 2024

Record last verified: 2024-11

Locations

CA (1)