NCT04041804|Unknown
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Sponsor study identifier
interventional
20
1 country
1
Study Start
February 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
July 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
OBJECTIVE: To evaluate the effects of different time intervals activations on the non-surgical maxillary expansion in adults. Methods: This study will include two groups, 10 adult patients each (mean age 20-35) with maxillary transverse deficiency and unilateral or bilateral crossbite. In the first group, the expansion is going to be activated every four days. In the second group, activation will occur every eight days. The primary outcomes are transverse dimension, the buccal cortical bone formation, and the upper premolar and molar labial inclination. Dentoalveolar changes will be evaluated using CBCT images and digital models.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 13, 2019
Actual (reported)August 1, 2019
Actual (reported)February 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
July 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Transversal distance between upper canines, first premolars and upper first molars
Distance between mesial fosa of each upper canines, first premolars and distance between central fosa of each upper first molars
Change from baseline to 6 months
Posterior teeth buccal inclination
Measure in CBCT in a coronal slice between the palatal plane and the dental axis
Change from baseline to 6 months
Buccal bone area evaluation
Measure in CBCT in a coronal slice, thickness of the buccal bone in upper first premolars and upper first molars
Change from baseline to 6 months
Bleeding on probing (BP)
Change from baseline to 6 months
Evaluation of the perception of pain by the patient (VAS)
Change from baseline to 6 months
Probing depth (PD)
Change from baseline to 6 months
Clinical attachment level (CAL)
Change from baseline to 6 months
Soft tissue recession (STR)
Change from baseline to 6 months
Non-surgical semi-rapid maxillary expansion (SRME) with the time intervals activation every week until getting the require expansion needed
Non-surgical semi-rapid maxillary expansion (SRME) with the time intervals activation every four days until getting the require expansion needed
A Banded Hyrax is going to be used in order to provide an increase in the maxillary transverse dimension
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Fundación Universitaria UniCIEO
Bogotá, DC, 110111, Colombia
Elsa Arango, DDS
Fundación Universitaria UniCIEO
First Submitted
February 13, 2019
First Posted
August 1, 2019
Study Start
February 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
Contact the study team to confirm eligibility.
July 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
September 2, 2020
Record last verified: 2020-08
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Source: ClinicalTrials.gov.
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