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

Louisiana State University

Status: Not yet enrolling

Conditions: Wound Heal

Treatments: Procedure: Free Gingival Graft Procedure

Study type: Interventional

Funder types: Other

Identifiers

NCT05921513

4863

Details and patient eligibility

About

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.

Full 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

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Adults aged ≥18 years,
• No history of medication affecting periodontal status in the last 6 months,
• No history of allergy to study medication or material,
• No use of tobacco,
• No history of pregnancy or lactation or contraceptive medication
• Good oral hygiene.

Exclusion criteria

• Previous palatal surgery
• Patient on anticoagulant therapy
• Uncontrolled diabetes,
• Rheumatoid arthritis,
• Osteoporosis.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

60 participants in 3 patient groups, including a placebo group

NC Group

Placebo Comparator group

Description:

This 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.

Treatment:

Procedure: Free Gingival Graft Procedure

S Group

Experimental group

Description:

This group is provided StellaLife Oral Care kit's mouth-rinse, gel and spray 2 times per day.

Treatment:

Procedure: Free Gingival Graft Procedure

C Group

Active Comparator group

Description:

This group is provided chlorhexidine mouth-rinse and placebo gel and spray 2 times per day.

Treatment:

Procedure: Free Gingival Graft Procedure