Clinical trial NCT05921513: Effects of StellaLife Oral Care Recovery Kit on Palatal Wound Healing After Free Gingival Graft
Official title: Effects of StellaLife Oral Care Recovery Kit on Palatal Wound Healing After Free Gingival Graft
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Wound Heal
Keywords: Inadequate Keratinized Gingiva
Mouthrinse
Lead sponsor: Louisiana State University Health Sciences Center in New Orleans
Sponsor class: OTHER
First posted: 2023-06-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel model: Patient will receive either normal saline mouth-rinse to rinse, or Chlorhexidine mouth-rinse with placebo gel and placebo oral spray or Stellalife Oral Care Kit with mouthrinse, gel and oral spray.
Primary purpose: SUPPORTIVE_CARE

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

Eligibility criteria: 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.

Primary outcomes:
measure: Wound Healing Estimation
timeFrame: Samples collected on Postoperative days: day 1, day 5, day 14, day 21 and day 28
Secondary outcomes:
measure: Epithelization Assessment
timeFrame: Samples collected on Postoperative days: day 1, day 5, day 14, day 21 and day 28
measure: Wound Exudate assessment
timeFrame: Starting on the day of the surgery and Postoperative Days: day 1, day 5, day 14, day 21 and day 28
measure: Wound Plaque assessment
timeFrame: Starting on the day of the surgery and Postoperative Days: day 1, day 5, day 14, day 21 and day 28
measure: Oral Health Impact Profile-14
timeFrame: Starting on the day of the surgery and Postoperative Days: day 1, day 5, day 14, day 21 and day 28
measure: Functional Pain Scale
timeFrame: Starting on the day of the surgery and Postoperative Days: day 1, day 5, day 14, day 21 and day 28
Other outcomes:
Locations:
city: New Orleans
country: United States
facility: LSUHSC School of Dentistry
state: Louisiana
Study officials:
affiliation: LSUHSC, School of Dentistry, New Orleans, LA
name: Vinayak Joshi
role: PRINCIPAL_INVESTIGATOR
References: