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Comparison of Oral Hygiene & Root Resorption During Orthodontic Treatment

NCT02745626 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2017-03-10

Study results available
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Summary

Orthodontic treatment has been traditionally carried out with fixed appliances involving the use of stainless steel brackets and archwires. The challenge has been to move teeth and their roots effectively while minimizing iatrogenic damage such as root resorption and gingival inflammation. In recent years, with the development of new appliances and brackets such as self-ligating brackets and clear aligners there have been reports of improved periodontal status, less iatrogenic root damage and improved hygiene during treatment. Although these treatment modalities have been rapidly accepted in clinical practice, both clinical and basic science research data regarding their overall biological compatibility to support higher levels of evidence based dentistry (e.g, randomized clinical trials) is lacking. In other words, their advantages and disadvantages in this regard have not yet been scientifically evaluated. Such quantification will provide invaluable information for improvements in these treatment modalities.

A randomized controlled clinical trial will be conducted with strict inclusion and exclusion criteria to test the following hypothesis (H) up to 18 months into treatment:

H-1: There is no difference in the amount of root resorption caused by the three different appliances.

H-2: Gingival health is not affected by the 'type of appliance' being used to correct the malocclusion.

H-3: There is no difference in the amount of bacterial count and the type of appliance being used for orthodontic treatment.

The hypothesis will be tested with the following specific aims (SA):

SA-1: To investigate the amount of orthodontically induced inflammatory root resorption generated by treatment.

SA-2: To evaluate the periodontal health of the patients with the different appliance systems.

SA-3: To determine the changes in Streptococcus mutans and total bacterial counts contained in the plaque of orthodontic patients.

SA-4: To ascertain whether there is an association between the microbial count and the type of appliance being used for orthodontic treatment

Conditions

  • Orthodontic Pathological Resorption of External Root
  • Complication of Personal Oral Hygiene

Interventions

DEVICE

Appliance

Orthodontic appliance to carry out orthodontic tooth movement.

Sponsors & Collaborators

  • Align Technology, Inc.

    collaborator INDUSTRY

  • UConn Health

    lead OTHER

Principal Investigators

  • Madhur Upadhyay, BDS,MDS,MDSc · UConn Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2015-05-31
Completion
2015-11-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02745626 on ClinicalTrials.gov