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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Wound Heal
• Intervention / Treatment: Procedure: Free Gingival Graft Procedure

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

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Vinayak Joshi, MS; Phone Number: 504-941-8280; Email: vjosh1@lsuhsc.edu
• Study Contact Backup: Name: Amber Kreko, DDS; Email: akreko@lsuhsc.edu

Study Locations

• United States
  • Louisiana
    • New Orleans, Louisiana, United States, 70119
      • LSUHSC School of Dentistry
      • Contact: Vinayak Joshi, MS, PhD; Email: vjosh1@lsuhsc.edu
      • Contact: Email: vjosh1@lsuhsc.edu
      • Principal Investigator: Vinayak Joshi, MS,Phd
      • Sub-Investigator: Eswar Kandaswamy, MS
      • Sub-Investigator: Panos Dragonas, MS
      • Sub-Investigator: Amber Kreko, DDS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: NC Group; 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.	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.
Experimental: S Group; This group is provided StellaLife Oral Care kit's mouth-rinse, gel and spray 2 times per day.	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.
Active Comparator: C Group; This group is provided chlorhexidine mouth-rinse and placebo gel and spray 2 times per day.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wound Healing Estimation	Clinical photographs of the donor site will be taken at baseline, immediately after surgery, and at each follow-up visit, to record the appearance A sterile paper measuring tape in millimeters will be placed on the length and width of the wound at the time getting the picture, then with use of the image analysis software the size (area in sq millimeter) and wound healing estimation will be made. The images will be analyzed with ImageJ software to determine area.	Samples collected on Postoperative days: day 1, day 5, day 14, day 21 and day 28

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Epithelization Assessment	A wound epithelization test will be done with hydrogen peroxide on each follow-up visits to record epithelization. The wound will be dried with gentle air flow and 3% hydrogen peroxide will be sprayed with a syringe. The appearance of bubbles will be considered as indication for incomplete epithelialization and will be dichotomously recorded (yes/no).	Samples collected on Postoperative days: day 1, day 5, day 14, day 21 and day 28
Wound Exudate assessment	The wound exudate sample will be collected using a sterile durapore membrane. The membrane would be held on the surface of the wound for 30 seconds to absorb the wound exudate and then transferred to 2ml plastic vial. All samples will be at -40 degree centigrade till further analysis. Expression of cytokine biomarkers and metabolomes will be analyzed in picogram/mL	Starting on the day of the surgery and Postoperative Days: day 1, day 5, day 14, day 21 and day 28
Wound Plaque assessment	Plaque samples over the wound will be collected using sterile Q tips. The Q-tips will be transferred into plastic vials containing 50 ul RNA latter. All samples will be at -40 degree centigrade till further analysis. The de-identified plaque samples would be sent to the lab for DNA isolation and high through output sequencing of bacterial genomes to measure the relative abundance of different bacterial phyla and classes	Starting on the day of the surgery and Postoperative Days: day 1, day 5, day 14, day 21 and day 28
Oral Health Impact Profile-14	The oral health-related quality of life will be assessed by the Oral Health Impact Profile scale (OHIP-14). Participants will be asked how frequently they had experienced the impact on each category in OHIP-14 with a 5-point scale (from 0 to 4). The total score of OHIP-14 will be calculated by adding the sum of each category from 14 questions (total score ranges from 0 to 56 points). Higher scores imply a poorer oral health quality of life, whereas lower scores indicate a better one.	Starting on the day of the surgery and Postoperative Days: day 1, day 5, day 14, day 21 and day 28
Functional Pain Scale	The patient experienced pain and discomfort will be assessed and by the Functional Pain Scale. Participants will be asked to rate their pain on a scale of 0 to 5. The scale will also be used to assess pain and questions related to analgesic use and postoperative discomfort and complications experienced. Highest score of 5 is intolerable pain and score of 0 is no pain.	Starting on the day of the surgery and Postoperative Days: day 1, day 5, day 14, day 21 and day 28

Collaborators and Investigators

• Sponsor: Louisiana State University Health Sciences Center in New Orleans
• Investigators: Principal Investigator: Vinayak Joshi, LSUHSC, School of Dentistry, New Orleans, LA

Study record dates

Study Major Dates

• Study Start (Estimated): July 15, 2023
• Primary Completion (Estimated): July 30, 2024
• Study Completion (Estimated): July 30, 2024

Study Registration Dates

• First Submitted: May 3, 2023
• First Submitted That Met QC Criteria: June 19, 2023
• First Posted (Actual): June 27, 2023

Study Record Updates

• Last Update Posted (Actual): June 27, 2023
• Last Update Submitted That Met QC Criteria: June 19, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Mouthrinse; Inadequate Keratinized Gingiva
• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: 4863

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Aggregated data will be made available at the time of publication

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes