Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06374329
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-24
First Post:
2024-04-15
Brief Title:
Effect of Interceptive Strategies on the Clinical Outcome of Impacted Maxillary Permanent Canines
Sponsor:
Universitaire Ziekenhuizen KU Leuven
Organization:
Universitaire Ziekenhuizen KU Leuven
Study Overview
Official Title:
Effect of Interceptive Strategies on the Clinical Outcome of Impacted Maxillary Permanent Canines - RCT Phase 2
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RCTcanines2
Brief Summary:
Canine impaction is a sign of abnormal dental development with potentially far-reaching consequences such as significant root resorption and loss of lateral incisors This compromises both aesthetics and function of the teeth making the prediction of canine tooth impaction increasingly important Interceptive orthodontic measures such as extraction of deciduous canines or molars or maxillary expansion aim to create extra space in the dental arch allowing the canines to position themselves better and normalizing their eruption pattern
This study corresponds to the second phase of an RCT based on the results of the first phase published in July 2023 S59030 Willems G Butaye C Raes M Zong C Begnoni G Cadenas de Llano-Pérula M Early prevention of maxillary canine impaction a randomized clinical trial Eur J Orthod 31454359-369 The first phase compared the effect of 3 interceptive strategies expansion extraction and no intervention on the position of impacted maxillary canines finding that maxillary expansion provides the most improvement on impacted canine position In second phase 8-year-old patients without posterior crossbite and lack of space in the dental arch are randomized to treatment with slow maxillary expansion with removable plates or no treatment These groups are additionally compared with patients with a crossbite and lack of space which always receive expansion treatment All selected patients will be followed up for at least 18 months The primary endpoint is to investigate the effect of maxillary expansion with removable plates on the position of maxillary canines prone to impaction during early mixed dentition assessed on panoramic X-rays The secondary endpoint is the assessment of the need for additional orthodontic treatment
This study corresponds to the second phase of an RCT based on the results of the first phase published in July 2023 S59030 Willems G Butaye C Raes M Zong C Begnoni G Cadenas de Llano-Pérula M Early prevention of maxillary canine impaction a randomized clinical trial Eur J Orthod 31454359-369 The first phase compared the effect of 3 interceptive strategies expansion extraction and no intervention on the position of impacted maxillary canines finding that maxillary expansion provides the most improvement on impacted canine position In second phase 8-year-old patients without posterior crossbite and lack of space in the dental arch are randomized to treatment with slow maxillary expansion with removable plates or no treatment These groups are additionally compared with patients with a crossbite and lack of space which always receive expansion treatment All selected patients will be followed up for at least 18 months The primary endpoint is to investigate the effect of maxillary expansion with removable plates on the position of maxillary canines prone to impaction during early mixed dentition assessed on panoramic X-rays The secondary endpoint is the assessment of the need for additional orthodontic treatment
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None