Debonding Clinical Trial
— DebondingOfficial title:
Does the Pain Experienced During Orthodontic Treatment and Bracket Removal Depend on the Architecture of the Bracket? A Comparative Study of Two Bracket Systems and Two Debonding Methods
Verified date | March 2024 |
Source | Jagiellonian University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The present research aimed to thoroughly investigate the impact of bracket architecture on pain perception during active treatment, debonding, and adhesive removal.
Status | Completed |
Enrollment | 100 |
Est. completion date | May 1, 2023 |
Est. primary completion date | May 1, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 12 Years and older |
Eligibility | Inclusion Criteria: - fixed appliance in both dental arches - brackets bonded using the Transbond XT adhesive system (3M Unitek, St. Paul, USA) following the manufacturer's instructions Exclusion Criteria: - periodontal disease - restorations or caries on buccal surfaces of the teeth, - consumption of analgesics within eight hours preceding the debonding appointment |
Country | Name | City | State |
---|---|---|---|
Poland | Jagiellonian University Collegium Medicum | Kraków |
Lead Sponsor | Collaborator |
---|---|
Piotr Fudalej |
Poland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pain during active treatment | Numerical Rating Scale (0-10) was used to assess pain level during active treatment. | On the day of debondig (at the end of active treatment). | |
Primary | Pain during brackets removal | Numerical Rating Scale (0-10) was used to assess pain during brackets debonding. | On the day of debondig (after debonding of each single bracket). | |
Primary | Pain on adhesive removal | Numerical Rating Scale (0-10) was used to assess pain during adhesive removal. | On the day of debondig (after adhesive removal in each quadrant). |