- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07793851
Fucoidan(Seaweed) Based Gel Around Osseous Defects
August 28, 2026 updated by: Krishnadevaraya College of Dental Sciences & Hospital
Clinical And Radiographic Evaluation Of Fucoidan Gel In Patients With Osseous Defects- A Case Series
The current study is a prospective case series study to evaluate the effect of Fucoidan gel around osseous defects to assess the wound healing and bone regeneration
Study Overview
Status
Completed
Conditions
Detailed Description
Five healthy individuals satisfying the inclusion and exclusion criteria were recruited for the study.
A detailed, thorough medical and dental history was obtained and each patient was subjected to comprehensive clinical and radiological examination.
All patients were informed about the nature of the study, procedure involved, potential benefits and risks associated with procedure and written informed consent were obtained from all patients.
All the patients underwent scaling and root planning.
Study Type
Observational
Enrollment (Actual)
5
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Karnataka
-
Bangalore, Karnataka, India, 562157
- Krishnadevaraya college of dental sciences and hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Probability Sample
Study Population
All the patients who meet the eligible criteria will undergo Scaling and root planning (SRP) as a part of Phase I therapy.
Patients with ≥6mm probing sites will undergo surgical therapy, patients presenting with different osseous defects will be treated with Fucoidan gel.
A total of 5 samples will be allotted to different defects
Description
Inclusion Criteria:
- Systemically healthy patients between 25 to 55 years.
- Stage II/III and Grade B periodontitis patient.
- Osseous defects (intra bony defects, compromised bone support and around dental implants)
Exclusion Criteria:
- Patients with systemic diseases.
- Smokers.
- Patients under anticoagulant therapy.
- Patients under bisphosphonates.
- Pregnant and lactating women
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
placement of fucoidan gel in osseous defects
Drug: Fucoidan extracted from F. Vesiculosus placement of fucoidan gel in osseous defects such as intrabony defect, compromised bone support
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
wound healing following placement of fucoidan gel
Time Frame: 7th day,14th day, 21st day, 1 month, at 3months and 6 months
|
Landry, Turnbull and Howley wound healing index
|
7th day,14th day, 21st day, 1 month, at 3months and 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
crestal bone level
Time Frame: baseline, 3month and 6 month
|
using RVG with 1 mm grid
|
baseline, 3month and 6 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: DR .Prabhuji MLV, MDS, Krishnadevaraya college of dental sciences and hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 11, 2025
Primary Completion (Actual)
October 11, 2025
Study Completion (Actual)
June 30, 2026
Study Registration Dates
First Submitted
August 24, 2026
First Submitted That Met QC Criteria
August 28, 2026
First Posted (Actual)
August 31, 2026
Study Record Updates
Last Update Posted (Actual)
August 31, 2026
Last Update Submitted That Met QC Criteria
August 28, 2026
Last Verified
August 1, 2026
More Information
Terms related to this study
Other Study ID Numbers
- KCDSHEC/IP/2025/44
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.