Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06604676
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-09-13
Brief Title:
Patient and Operator Centered Outcomes Concerning Connective Tissue Graft Should Be Considered to Choose Adequately Which Protocol to Use
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Patient and Operator Centered Outcomes in Harvesting Technique of Soft Tissue Graft Guided Versus Non-Guided
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
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:
RCT
Brief Summary:
The goal of this clinical trial is to evaluate patient and operator centered outcomes after connective tissue graft harvesting with a fully digital workflow and compare this approach with a conventional one The main questions it aims to answer are
Does it differ in patient- and operator-centered outcomes between the conventional and digital workflow
What is the difference in time efficiency between conventional and digital protocols Researchers will compare digital guided versus conventional technique to choose adequately which protocol to use
Participants will
Receive periodontal surgery to treat gingival recession site
Visit the clinic after 2 weeks for suture removal amp filling the survey
The time will be recorded during the surgery
Does it differ in patient- and operator-centered outcomes between the conventional and digital workflow
What is the difference in time efficiency between conventional and digital protocols Researchers will compare digital guided versus conventional technique to choose adequately which protocol to use
Participants will
Receive periodontal surgery to treat gingival recession site
Visit the clinic after 2 weeks for suture removal amp filling the survey
The time will be recorded during the surgery
Detailed Description:
50 sites will be included All investigations will be carried out in accordance with the 1975 Helsinki Declaration as revised in 2013 for ethical approval All participants will provide written informed consent after receiving explanations on study objectives and procedures Primary outcomes will be patient- and operator-centered outcomes Patient- and operator-centered outcomes will be assessed through visual analogue scale VAS questionnaires containing self-developed questions about each phase of the treatment which will be administered at the end of each phase The questionnaires will be administered as part of a survey which aimed to obtain information about the dental practices Secondary outcomes will be time-efficiency by assessing workflow duration and number of appointments needed to complete the procedure The treatment phases will include digital analysis of landmarks and design of the guide and surgical phase free gingival graft harvesting Time will be recorded in minutes All the parameters will be recorded in the clinical chart by the same two operators not involved in the treatment after each phase was completed The planned duration for the research will be 6 months
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