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CompletedNCT07736287Updated Jul 30, 2026

Fucoidan(Seaweed) Based Gel Around Immediate Implants

A Phase 3 interventional study of Fucoidan extracted from F. Vesiculosus and immediate implant placement in Wound Healing and Bone Regeneration, sponsored by Krishnadevaraya College of Dental Sciences & Hospital. Completed at 1 site in India. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-30.

Sponsored by Krishnadevaraya College of Dental Sciences & Hospital · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 2 months after the study started (first participant enrolled May 2025, registered Jul 2026).
Phase
Phase 3
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study summary

The current study is a prospective randomised parallel mouth study to evaluate the effect of Fucoidan gel around immediate implant to assess the wound healing and bone regeneration in comparison to regular implant placement without any gel.

Read the detailed description

Twenty 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.

Following randomization, the site will be assigned to one of the two study groups.

  1. test group(immediate implant+ fucoidan gel)
  2. control group (only immediate implant without any gel)
02

Conditions studied

  • Wound Healing
  • Bone Regeneration
03

In context

Lead sponsor

Krishnadevaraya College of Dental Sciences & Hospital is the lead sponsor of 51 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Patients at least above 18 years of age.
  2. Patients presenting with Stage I/II and Grade B periodontitis.
  3. Class I extraction socket defects according to modified Elian et al 2021.
  4. The recipient sites of the implant will be free from pathological conditions.
  5. Patients who will comply with oral health care instructions and necessary visits
  6. Cases undergoing extraction for dental caries or endodontic conditions.

Exclusion criteria

Exclusion Criteria:

  1. Uncontrolled diabetes and severe cardiovascular or infectious diseases
  2. Patients with Intravenous and oral bisphosphonate therapy.
  3. Patients who are unwilling to return for the follow-up examination.
  4. Smokers, lactating and pregnant women.
  5. Patients who are psychologically unable to participate.
  6. Patients with poor oral hygiene.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Active comparator
    fucoidan gel

    Patients with immediate implant with Fucoidan gel implant surface coating prior to implant placement.

    Drug: Fucoidan extracted from F. Vesiculosus

  • Experimental
    without any gel

    Patients with immediate implant without any implant surface coating prior to implant placement.

    Procedure: immediate implant placement

Interventions

  • DrugFucoidan extracted from F. Vesiculosus

    patients with immediate implant with Fucoidan gel coating prior to implant placement

  • Procedureimmediate implant placement

    patients with immediate implant without any implant surface coating prior to implant placement

06

What researchers measure

Primary outcomes

  1. wound healing index after immediate implant placement

    Landry, Turnbull and Howley wound healing index

    Time frame: 7th day,14th day, 21st day, 1month, 3months and 6 months

Secondary outcomes

  1. crestal bone level

    using RVG with 1 mm grid

    Time frame: baseline, 3month and 6 month

  2. gingival tissue thickness

    Time frame: baseline , 3months and 6 months

  3. keratinised tissue width

    Time frame: baseline,3months and 6 months

  4. CBCT : linear measurement

    Time frame: baseline and 6months

  5. Plaque Index

    Time frame: 3months

  6. Gingival Index

    Time frame: 3months

  7. Modified sulcular bleeding index

    Time frame: 3 months

  8. Probing depth (PD)

    Time frame: 1month,3month and 6 month

07

Study locations

1 site
  • Krishnadevaraya college of dental sciences and hospital
    Bangalore, Karnataka 562157, India
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 30, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07736287
Lead sponsor
Krishnadevaraya College of Dental Sciences & Hospital
Responsible party
Dr Prabhuji MLV (HEAD OF DEPARTMENT PERIODONTOLOGY, Krishnadevaraya College of Dental Sciences & Hospital) — Principal investigator
First posted
Jul 30, 2026
Start date
May 11, 2025
Primary completion
Nov 5, 2025
Completion
Jul 5, 2026
Last update
Jul 30, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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