Fucoidan(Seaweed) Based Gel Around Osseous Defects

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

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.

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