Ignite Creation Date:
2024-05-06 @ 7:11 PM
Last Modification Date:
2024-10-26 @ 3:02 PM
Study NCT ID:
NCT05921513
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-06-27
First Post:
2023-05-03
Brief Title:
Effects of StellaLife Oral Care Recovery Kit on Palatal Wound Healing After Free Gingival Graft
Sponsor:
Louisiana State University Health Sciences Center in New Orleans
Organization:
Louisiana State University Health Sciences Center in New Orleans
Study Overview
Official Title:
Effects of StellaLife Oral Care Recovery Kit on Palatal Wound Healing After Free Gingival Graft
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-06
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 study looks to compare the clinical effects of StellaLife VEGA Oral Care Kit with chlorhexidine mouth-rinse on patient comfort wound healing wound epithelialization bacterial levels and colonization of the wounds
Detailed Description:
A total of 60 participants will be recruited from those needing and have been treatment planned for a free gingival graft surgery to increase keratinized gum The study subjects will be randomly allocated to either negative control group NC chlorhexidine group C or StellaLife group S by randomization done using a computer-generated table
The NC group is provided normal saline mouth-rinse to rinse 2 times per day along with placebo gel to be applied 2 times and placebo oral spray The S group will use StellaLife Oral Care mouth-rinse gel and spray 2 times per day The C group will use chlorhexidine mouth-rinse and placebo gel and spray 2 times per day All groups beginning the same day and continuing for the duration of two weeks All patients will receive a protective splint Following this subjective and objective measurements on the success of the mouthwash and oral care kit will be measured
Patients will be evaluated post operatively following surgery as mentioned below
Wound Healing Assessment and Epithelization Assessment Postoperative Days 1 5 14 21 and 28
Oral Health Impact Profile-14 and Functional Pain Scale Starting on the day of the surgery and Postoperative Days 1 5 14 21 and 28
Wound Exudate assessment Samples collected on Postoperative Days 1 5 14 21 and 28
Wound Plaque assessment Starting on the day of the surgery and Postoperative Days 1 5 14 21 and 28
The NC group is provided normal saline mouth-rinse to rinse 2 times per day along with placebo gel to be applied 2 times and placebo oral spray The S group will use StellaLife Oral Care mouth-rinse gel and spray 2 times per day The C group will use chlorhexidine mouth-rinse and placebo gel and spray 2 times per day All groups beginning the same day and continuing for the duration of two weeks All patients will receive a protective splint Following this subjective and objective measurements on the success of the mouthwash and oral care kit will be measured
Patients will be evaluated post operatively following surgery as mentioned below
Wound Healing Assessment and Epithelization Assessment Postoperative Days 1 5 14 21 and 28
Oral Health Impact Profile-14 and Functional Pain Scale Starting on the day of the surgery and Postoperative Days 1 5 14 21 and 28
Wound Exudate assessment Samples collected on Postoperative Days 1 5 14 21 and 28
Wound Plaque assessment Starting on the day of the surgery and Postoperative Days 1 5 14 21 and 28
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?:
True
Is an FDA AA801 Violation?:
None