NCT05921513

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 3, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 27, 2023

Completed
18 days until next milestone

Study Start

First participant enrolled

July 15, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2024

Completed
Last Updated

June 27, 2023

Status Verified

June 1, 2023

Enrollment Period

1 year

First QC Date

May 3, 2023

Last Update Submit

June 19, 2023

Conditions

Wound Heal

Keywords

Inadequate Keratinized GingivaMouthrinse

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Epithelization Assessment

    Samples collected on Postoperative days: day 1, day 5, day 14, day 21 and day 28

  • Wound Exudate assessment

    Starting on the day of the surgery and Postoperative Days: day 1, day 5, day 14, day 21 and day 28

  • Wound Plaque assessment

    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

    Starting on the day of the surgery and Postoperative Days: day 1, day 5, day 14, day 21 and day 28

  • Functional Pain Scale

    Starting on the day of the surgery and Postoperative Days: day 1, day 5, day 14, day 21 and day 28

Study Arms (3)

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.

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.

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.

Procedure: Free Gingival Graft Procedure

Interventions

Free Gingival Graft ProcedurePROCEDURE

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.

C GroupNC GroupS Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

LSUHSC School of Dentistry

New Orleans, Louisiana, 70119, United States

Location

Study Officials

  • Vinayak Joshi

    LSUHSC, School of Dentistry, New Orleans, LA

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Vinayak Joshi, MS

CONTACT

504-941-8280vjosh1@lsuhsc.edu

Amber Kreko, DDS

CONTACT

akreko@lsuhsc.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
The participants will be masked to which mouth-rinse, gel and spray they are receiving.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 3, 2023

First Posted

June 27, 2023

Study Start

July 15, 2023

Primary Completion

July 30, 2024

Study Completion

July 30, 2024

Last Updated

June 27, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Aggregated data will be made available at the time of publication

Locations

US(1)