Wound HealNCT05921513
Effects of StellaLife Oral Care Recovery Kit on Palatal Wound Healing After Free Gingival Graft
A study testing Free Gingival Graft Procedure in people with Wound Heal, run by Louisiana State University Health Sciences Center in New Orleans at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Wound Heal
- What is being tested?
- Free Gingival Graft Procedure
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2023to 30 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Previous palatal surgery
- Patient on anticoagulant therapy
- Uncontrolled diabetes,
- Rheumatoid arthritis,
- Osteoporosis.
Trial locations and contacts
1 site in 1 country.
Amber Kreko, DDS contact
United States1 site
LSUHSC School of Dentistry
New Orleans, Louisiana, 70119
Vinayak Joshi, MS, PhD, vjosh1@lsuhsc.edu
vjosh1@lsuhsc.edu
About this study
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.
Read the 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
- Being tested
- Free Gingival Graft Procedure
- Keywords
- Inadequate Keratinized Gingiva, Mouthrinse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Free Gingival Graft ProcedureProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| NC Group | Placebo comparator | 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. Receives: Procedure: Free Gingival Graft Procedure |
| S Group | Experimental | This group is provided StellaLife Oral Care kit's mouth-rinse, gel and spray 2 times per day. Receives: Procedure: Free Gingival Graft Procedure |
| C Group | Active comparator | This group is provided chlorhexidine mouth-rinse and placebo gel and spray 2 times per day. Receives: Procedure: Free Gingival Graft Procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Samples collected on Postoperative days: day 1, day 5, day 14, day 21 and day 28
Secondary outcomes (5)
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).
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: Starting on the day of the surgery and Postoperative Days: day 1, day 5, day 14, day 21 and day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2023
- Study start15 Jul 2023 (estimated)
- Primary completion30 Jul 2024 (estimated)
- Study completion30 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound HealStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Louisiana State University Health Sciences Center in New Orleans
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vinayak Joshi, Principal investigator, LSUHSC, School of Dentistry, New Orleans, LA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05921513
- Sponsor's protocol ID
- 4863
- Status last verified
- Jun 2023
- First submitted
- 3 May 2023
- Last updated
- 27 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Aggregated data will be made available at the time of publication
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of StellaLife Oral Care Recovery Kit on Palatal Wound Healing After Free Gingival Graft
- ClinicalTrials.gov ID
- NCT05921513
- Acronym / sponsor ID
- 4863
- Conditions
- Wound Heal
- Keywords
- Inadequate Keratinized Gingiva, Mouthrinse
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Louisiana State University Health Sciences Center in New OrleansUniversity, hospital or other
- Study start
- 15 Jul 2023 (estimated)
- Primary completion
- 30 Jul 2024 (estimated)
- Study completion
- 30 Jul 2024 (estimated)
- First posted
- 27 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| NC Group | Placebo comparator | Procedure: Free Gingival Graft ProcedureThis 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. |
| S Group | Experimental | Procedure: Free Gingival Graft ProcedureThis group is provided StellaLife Oral Care kit's mouth-rinse, gel and spray 2 times per day. |
| C Group | Active comparator | Procedure: Free Gingival Graft ProcedureThis group is provided chlorhexidine mouth-rinse and placebo gel and spray 2 times per day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- Previous palatal surgery
- Patient on anticoagulant therapy
- Uncontrolled diabetes,
- Rheumatoid arthritis,
- Osteoporosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Free Gingival Graft ProcedureThis 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. | Procedure or surgery | C Group, NC Group, S Group |
Primary outcome
Wound Healing Estimation
Time frame: Samples collected on Postoperative days: day 1, day 5, day 14, day 21 and day 28
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.
5 secondary outcomes
Epithelization Assessment
Time frame: Samples collected on Postoperative days: day 1, day 5, day 14, day 21 and day 28
Wound Exudate assessment
Time frame: Starting on the day of the surgery and Postoperative Days: day 1, day 5, day 14, day 21 and day 28
Wound Plaque assessment
Time frame: 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
Time frame: Starting on the day of the surgery and Postoperative Days: day 1, day 5, day 14, day 21 and day 28
Functional Pain Scale
Time frame: Starting on the day of the surgery and Postoperative Days: day 1, day 5, day 14, day 21 and day 28
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2023.
- Individual participant dataSharing planned: No. Aggregated data will be made available at the time of publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amber Kreko, DDS contact
Vinayak Joshi principal investigator
LSUHSC, School of Dentistry, New Orleans, LA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Free Gingival Graft Procedure in people with Wound Heal, run by Louisiana State University Health Sciences Center in New Orleans at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vinayak Joshi, MS (504-941-8280, vjosh1@lsuhsc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound Healing Estimation (time frame: Samples collected on Postoperative days: day 1, day 5, day 14, day 21 and day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2023.