Ignite Creation Date:
2025-12-24 @ 4:36 PM
Ignite Modification Date:
2025-12-24 @ 4:36 PM
Study NCT ID:
NCT04409366
Status:
COMPLETED
Last Update Posted:
2020-06-01
First Post:
2020-05-26
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
One- Versus Two-Stage Aesthetic Crown Lengthening
Sponsor:
Universidad Complutense de Madrid
Organization:
Study Overview
Official Title:
One- Versus Two-Stage Aesthetic Crown Lengthening for Restorative Purposes: A Randomized Controlled Trial.
Status:
COMPLETED
Status Verified Date:
2020-05
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:
None
Brief Summary:
This randomized controlled trial was aimed at assessing the efficacy of a two-stage crown lengthening intervention (SCL) for restorative purposes in the aesthetic zone compared with a one-stage crown lengthening procedure (CCL).
Detailed Description:
Subjects were randomly allocated to receive SCL or CCL. SCL consisted of full thickness flaps followed by bone recontouring and minor gingivectomy 4 months postoperatively, if required. In CCL, osseous recontouring after sub-marginal incisions was performed, followed by flap repositioning. Records were obtained at baseline, 4 months (only in SCL), 6 and 12 months. Primary outcome was the precision in achieving a predetermined gingival margin position. Other outcomes were changes in the gingival margin position and keratinized tissue width (KTW) at 12 months, and patient-reported outcomes (PROMs) using the OHIP-14 tool.
Study Oversight
Has Oversight DMC:
False
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?: