Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 4:55 AM
Ignite Modification Date:
2025-12-25 @ 4:55 AM
NCT ID:
NCT07301918
Brief Summary:
Design: Two-arm parallel randomized clinical trial in mixed dentition (6-12 years).
Arms: (1) 9 mm, 900 g leaf expander; (2) 9 mm Hyrax expander. Follow-up: From appliance insertion → completion of intended expansion → 6-month retention.
Primary outcome: Pain perception during the first 7 days post-insertion (daily patient-reported scale).
Secondary outcomes: Skeletal and dental changes on CBCT.
Detailed Description:
Participants receive a banded maxillary expansion appliance cemented to maxillary first permanent molars, assigned to:
Leaf expander arm: Nickel-titanium leaf-spring expander, 9 mm screw, delivering force of \~900 g.
Hyrax expander arm: Conventional tooth-borne jackscrew expander, 9 mm screw. Standard activation: two turns per week.
Retention: Both appliances kept passively in situ for 6 months of retention following achievement of planned expansion.
Study:
NCT07301918
Study Brief:
Protocol Section:
NCT07301918