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Procedure
StellaLife Recovery Kit for Oral Wound Healing
N/A
Waitlist Available
Led By Vinayak Joshi
Research Sponsored by Louisiana State University Health Sciences Center in New Orleans
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up samples collected on postoperative days: day 1, day 5, day 14, day 21 and day 28
Awards & highlights
Study Summary
This trial examines how different products affect healing and comfort in patients with oral wounds.
Who is the study for?
This trial is for adults over 18 with good oral hygiene, who haven't taken meds affecting gums in the last 6 months, aren't allergic to trial materials, don't use tobacco, and aren't pregnant or breastfeeding.Check my eligibility
What is being tested?
The study compares StellaLife VEGA Oral Care Kit with chlorhexidine mouth-rinse. It focuses on patient comfort, how well wounds heal after a Free Gingival Graft Procedure, and bacterial levels in the wound.See study design
What are the potential side effects?
Possible side effects may include discomfort at the wound site, irritation from mouth rinses or allergic reactions to ingredients in the StellaLife kit or chlorhexidine.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ samples collected on postoperative days: day 1, day 5, day 14, day 21 and day 28
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~samples collected on postoperative days: day 1, day 5, day 14, day 21 and day 28
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Wound Healing Estimation
Secondary outcome measures
Epithelization Assessment
Functional Pain Scale
Oral Health Impact Profile-14
+2 moreTrial Design
3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: S GroupExperimental Treatment1 Intervention
This group is provided StellaLife Oral Care kit's mouth-rinse, gel and spray 2 times per day.
Group II: C GroupActive Control1 Intervention
This group is provided chlorhexidine mouth-rinse and placebo gel and spray 2 times per day.
Group III: NC GroupPlacebo Group1 Intervention
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.
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Who is running the clinical trial?
Louisiana State University Health Sciences Center in New OrleansLead Sponsor
114 Previous Clinical Trials
44,141 Total Patients Enrolled
Vinayak JoshiPrincipal InvestigatorLSUHSC, School of Dentistry, New Orleans, LA
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with osteoporosis.I am currently on blood thinner medication.I have rheumatoid arthritis.My diabetes is not under control.I have had surgery on the roof of my mouth before.I am 18 years old or older.I haven't taken any medication that affects my gum health in the last 6 months.I have never been pregnant, breastfed, or used contraceptive medication.
Research Study Groups:
This trial has the following groups:- Group 1: S Group
- Group 2: C Group
- Group 3: NC Group
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are any vacancies open for participants in this trial?
"According to clinicaltrials.gov, this project is no longer in search of potential candidates; the trial was posted on 15 July 2023 and last amended 19 June 2023. Despite that, there are still 806 other medical trials currently recruiting participants."
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