Ignite Creation Date:
2025-12-18 @ 9:44 AM
Ignite Modification Date:
2025-12-23 @ 9:50 PM
Study NCT ID:
NCT05921513
Status:
None
Last Update Posted:
2023-06-27 00:00:00
First Post:
2023-05-03 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of StellaLife Oral Care Recovery Kit on Palatal Wound Healing After Free Gingival Graft
Sponsor:
None
Organization:
Study Overview
Official Title:
Effects of StellaLife Oral Care Recovery Kit on Palatal Wound Healing After Free Gingival Graft
Status:
None
Status Verified Date:
2023-06
Last Known Status:
NOT_YET_RECRUITING
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:
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
Detailed Description:
None
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?: