Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06633822
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-08
Brief Title:
Crown Lengthening in Aesthetic Anterior Sector by Means of Guided Digital Planning Ramdomized Controlled Clinical Trial
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Crown Lengthening in Aesthetic Anterior Sector by Means of Guided Digital Planning 12-month Randomized Controlled Clinical Trial Comparing the Efficacy of Digital Versus Analog Protocol
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of this research is to compare the diagnostic accuracy in the detection of the cementoenamel junction CEJ and alveolar bone ridge using guided digital planning versus conventional analog planning for patients with excessive gingival exposure in the smile gummy smile due at least in part to altered passive eruption
Detailed Description:
Forty-four subjects will be randomly assigned to the planning groups according to a digital methodology DM n22 or an analog methodology AM n22 Surgical guides will be developed to establish the location of the acementoenamel junction and bone crest The digital methodology will consist of obtaining a digital scan and a computed tomography CBCT that will be aligned using a digital program for the elaboration of a digital wax-up and fabrication of a printed surgical template The analog wax-up will be elaborated based on a silicone impression and periapical radiographs with parallel technique which will allow us to elaborate an essix type surgical splint Measurements will be recorded at baseline on the day of surgery at 4 6 and 12 months of follow-up Variables related to the patients experience will also be recorded
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None