NCT05921513

Effects of StellaLife Oral Care Recovery Kit on Palatal Wound Healing After Free Gingival Graft

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Louisiana State University Health Sciences Center in New Orleans · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Conditions

• Wound Heal

Interventions

Type	Name	Description
PROCEDURE	Free Gingival Graft Procedure	This procedure is done to increase the width of keratinized gingiva around teeth or dental implant. The healing of the palatal wound at the donor site will be recorded.

Timeline

• Start date: 2023-07-15
• Primary completion: 2024-07-30
• Completion: 2024-07-30
• First posted: 2023-06-27
• Last updated: 2023-06-27

Locations

1 site across 1 country: United States