CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 68 enrolled
Drug / intervention
Appliancedevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02745626
NCT02745626N/ACompleted

Comparison of Root Resorption, Microbial Colonization & Gingival Health Between Clear Aligners, Self-Ligating Brackets & Conventional Brackets- A Randomized Controlled Clinical Trial

UConn Health·interventional·Posted Apr 20, 2016·Updated Mar 10, 2017

In Brief

A clinical study evaluating Appliance for Orthodontic Pathological Resorption of External Root and Complication of Personal Oral Hygiene. Completed, enrolled 68 participants across 1 site.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedApr 20, 2016
Enrollment StartDec 1, 2011
Primary CompletionMay 1, 2015
Study CompletionNov 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 10.2 years ago

Interventions

Appliancedevice

Orthodontic appliance to carry out orthodontic tooth movement.