Effects of StellaLife Oral Care Recovery Kit on Palatal Wound Healing After Free Gingival Graft
NCT ID: NCT05921513
Last Updated: 2023-06-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
60 participants
INTERVENTIONAL
2023-07-15
2024-07-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effect of Mouthwashes on Oral Wound Healing and Microbiome
NCT05270382
Assessing the Efficacy of a Hydrogen Peroxide Gel for Oral Wound Healing and Oral Hygiene
NCT06370260
Early Healing of Oral Soft Tissues: a Clinical and Biomolecular Analysis. Part II
NCT04276129
Treatment of Periodontal Disease With Two Different Bioactive Gels for Home Oral Care
NCT04781478
Protocol Efficacy of Mouthwashes in Experimental Gingivitis
NCT07270952
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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.
S Group
This group is provided StellaLife Oral Care kit's mouth-rinse, gel and spray 2 times per day.
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.
C Group
This group is provided chlorhexidine mouth-rinse and placebo gel and spray 2 times per day.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* Patient on anticoagulant therapy
* Uncontrolled diabetes,
* Rheumatoid arthritis,
* Osteoporosis.
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Louisiana State University Health Sciences Center in New Orleans
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Vinayak Joshi
Role: PRINCIPAL_INVESTIGATOR
LSUHSC, School of Dentistry, New Orleans, LA
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
LSUHSC School of Dentistry
New Orleans, Louisiana, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Role: backup
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
4863
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.