Inflammatory markers in orthodontic treatment with clear aligners: split mouth clinical trial

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN32624758

Enrollment

Registered

2017-03-09

Start date

2015-03-20

Completion date

Unknown

Last updated

2017-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malocclusion Oral Health Malocclusion, unspecified

Interventions

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 r

Eligibility

Sex/Gender

All

Inclusion criteria

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)

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
No secondary outcome measures	—

Countries

Italy

Contacts

Public ContactAndrea Deregibus

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026