Ignite Creation Date:
2025-12-24 @ 5:24 PM
Ignite Modification Date:
2025-12-25 @ 10:01 PM
Study NCT ID:
NCT06940050
Status:
RECRUITING
Last Update Posted:
2025-10-01
First Post:
2025-03-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparing CAF and TCAF With Soft Tissue Grafting for Treating Multiple Recessions in the Premandibula.
Sponsor:
University Hospital, Ghent
Organization:
Study Overview
Official Title:
An RCT Between Coronally Advanced Flap (CAF) and Tunneled Coronally Advanced Flap (TCAF) in Combination With Soft Tissue Graft for Multiple Recession Coverage.
Status:
RECRUITING
Status Verified Date:
2025-09
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:
Multiple techniques can be used for recession coverage. The most common techniques are : tunnel technique (T), coronally advanced flap (CAF) or a combination of both (TCAF). Tunnel and coronally advanced flap are frequently used in clinical practice, whereas the combined technique is a rather recent developed surgical approach.
This randomized controlled trial compares CAF and TCAF to determine which technique provides better root coverage for receding gums in the lower front teeth. The main question it aims to answer is:
\- What is the average root coverage achieved with each technique in the short and long term?
This may be clinically relevant because covering gum recession can reduce tooth sensitivity, improve aesthetics and make oral hygiene easier.
Researchers will compare the coronally advanced flap (CAF = the gum is detached and repositioned higher) with the tunneled coronally advanced flap (TCAF = the gum is undermined, only partially detached and repositioned higher). In both techniques, a small piece of tissue is removed from the palate, which is used to cover the recession. The purpose of the connective tissue graft under the flap/tunnel is to increase thickness and provide support.
Participants will:
* Undergo surgery (CAF or TCAF, randomly assigned) to cover recessions
* Attend regular check-ups for up to 10 years after surgery
* Keep a postoperative journal (recording medication use, pain levels, tooth sensitivity, etc.)
This randomized controlled trial compares CAF and TCAF to determine which technique provides better root coverage for receding gums in the lower front teeth. The main question it aims to answer is:
\- What is the average root coverage achieved with each technique in the short and long term?
This may be clinically relevant because covering gum recession can reduce tooth sensitivity, improve aesthetics and make oral hygiene easier.
Researchers will compare the coronally advanced flap (CAF = the gum is detached and repositioned higher) with the tunneled coronally advanced flap (TCAF = the gum is undermined, only partially detached and repositioned higher). In both techniques, a small piece of tissue is removed from the palate, which is used to cover the recession. The purpose of the connective tissue graft under the flap/tunnel is to increase thickness and provide support.
Participants will:
* Undergo surgery (CAF or TCAF, randomly assigned) to cover recessions
* Attend regular check-ups for up to 10 years after surgery
* Keep a postoperative journal (recording medication use, pain levels, tooth sensitivity, etc.)
Detailed Description:
None
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?:
False
Is an FDA AA801 Violation?: