Condition category
Oral Health
Date applied
03/02/2017
Date assigned
09/03/2017
Last edited
09/03/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Malocclusion is a problem in the way the upper and lower teeth fit together when biting or chewing. Orthodontic treatment can be used to improve the appearance, position and function of the teeth. In the last few decades increasing numbers of adults have sought orthodontic treatment and expressed a desire for better looking and more comfortable alternatives to traditional metal braces (often referred to as “train tracks”). Clear aligners, also known as “invisible braces”, are removable retainers which apply pressure to the teeth, pushing them into the correct position. This study aims to examine the mechanisms of tooth movement by examining the make-up of the fluid found along the gum line (gingival crevicular fluid) in patients using clear aligners.

Who can participate?
Patients aged over 18 with malocclusion requiring orthodontic treatment

What does the study involve?
All participants are treated with clear aligners. For a period of 3 weeks one second molar (back tooth) is randomly selected for a single movement of 0.25 mm, and the contralateral (opposite) tooth is used as a control (i.e. no movement). For all the participants, before treatment and then at 1 hour, 7 days and 21 days after treatment, samples of fluid from the gum line are taken using special paper strips, which are tested in the laboratory for any chemical markers of tooth movement.

What are the possible benefits and risks of participating?
Participants will benefit from correction of their malocclusion. There are no risks expected for those taking part in the study.

Where is the study run from?
University of Torino (Italy)

When is the study starting and how long is it expected to run for?
March 2014 to January 2017

Who is funding the study?
University of Torino (Italy)

Who is the main contact?
Dr Andrea Deregibus

Trial website

Contact information

Type

Public

Primary contact

Dr Andrea Deregibus

ORCID ID

Contact details

CIR Dental School Lingotto
Via Nizza 230
Turin
10126
Italy

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

orthomarkers2016

Study information

Scientific title

Biochemical markers of bone metabolism during dental orthodontic treatment with clear aligners: split-mouth clinical trial

Acronym

Study hypothesis

The aim of this study is to find out if the bone remodeling markers induced by Invisalign aligners during distalization movements significantly different from sites with no orthodontic movements.

Ethics approval

Ethics Board of The Health And Science City of Turin (Comitato Etico Interaziendale A.O.U. Città della Salute e della Scienza di Torino), 15/09/2016, ref: 0089263

Study design

Single-centre randomised split-mouth trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

No participant information sheet available

Condition

Malocclusion

Intervention

A single group of 21 patients requiring orthodontic treatment will be treated with clear aligners (Invisalign®, Align Technology, San José, CA, USA). For a period of 3 weeks one second molar will be randomly selected as study item and the contralateral will be used as control item. Using a dedicated software (ClinCheck®, Align Technology, San José, CA, USA) a single movement of 0.25 mm will be set on the first clear aligner only for the selected second molar.

Gingival Crevicular Fluid (GCF) samples will be collected using periopaper strips (Harco, Tustin, Calif). Samples will be collected at the mesiobuccal and mesiolingual sites of control and test teeth at baseline, at 1 hour, at 7 days, and 21 days after placement of the appliances. Teeth will be isolated with cotton rolls, cleaned of plaque deposits, and dried gently with air before paper strips will be applied 1 mm subgingivally for 30 seconds. The volume of the sample on the paper strips will be measured using a calibrated Periotron 8000 (Harco). The readings from the Periotron will be converted to an actual volume (microliters) by reference to the standard curve calibrated with human serum.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

Cytokine concentration (interleukin 1-beta, TGF-beta, RANKL, OPG and OPN), determined from GCF samples using titration and centrifugation at baseline, 1 hour, 7 days and 21 days

Secondary outcome measures

No secondary outcome measures

Overall trial start date

20/03/2014

Overall trial end date

30/01/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age >18 years
2. Absence of systemic diseases influencing bone metabolism and/or healing process
3. Good oral hygiene (FMPS e FMBS <20%)
4. Dentoskeletal Class I malocclusion (Witts appraisal)
5. Mild crowding (mean crowding 6 mm)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

21 patients

Participant exclusion criteria

1. Smokers
2. Have gingivitis
3. Have probing pocket depths ≥4 mm
4. Have loss of clinical attachment ≥2 mm in the selected or adjacent teeth
5. Had taken anti-inflammatory or antibiotic medications within the previous 6 months

Recruitment start date

20/03/2015

Recruitment end date

20/03/2016

Locations

Countries of recruitment

Italy

Trial participating centre

Dental School, Department of Orthodontics
Via Nizza 230
Turin
10126
Italy

Sponsor information

Organisation

University of Torino

Sponsor details

CIR Lingotto Dental School
Via Nizza 230
Turin
10126
Italy

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

Università degli Studi di Torino

Alternative name(s)

University of Turin, UNITO

Funding Body Type

government organisation

Funding Body Subtype

government non-federal

Location

Italy

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal in 2018

IPD sharing plan
The datasets generated during and/or analysed during the current study are/will be available upon request from Prof. Andrea Deregibus

Intention to publish date

30/01/2018

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes