Fucoidan(Seaweed) Based Gel Around Immediate Implants

NCT07736287 | Completed Phase 3

• 1 other identifier: KCDSHEC/IP/2025/43
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Wound Healing; Bone Regeneration

Outcome Measures

Primary Outcomes (1)

• wound healing index after immediate implant placement

  Landry, Turnbull and Howley wound healing index

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

Secondary Outcomes (8)

• crestal bone level

  baseline, 3month and 6 month

• gingival tissue thickness

  baseline , 3months and 6 months

• keratinised tissue width

  baseline,3months and 6 months

• CBCT : linear measurement

  baseline and 6months

• Plaque Index

  3months

Study Arms (2)

fucoidan gel

ACTIVE COMPARATOR

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

Drug: Fucoidan extracted from F. Vesiculosus

without any gel

EXPERIMENTAL

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

Procedure: immediate implant placement

Interventions

Fucoidan extracted from F. Vesiculosus DRUG

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

fucoidan gel

immediate implant placement PROCEDURE

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

without any gel

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Krishnadevaraya College of Dental Sciences & Hospital: lead

Study Sites (1)

Krishnadevaraya college of dental sciences and hospital

Bangalore, Karnataka, 562157, India

Location

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: HEAD OF DEPARTMENT PERIODONTOLOGY

Model Details: life extension potimised fucodian capsules was used for this study

Study Record Dates

• First Submitted: July 20, 2026
• First Posted: July 30, 2026
• Study Start: May 11, 2025
• Primary Completion: November 5, 2025
• Study Completion: July 5, 2026
• Last Updated: July 30, 2026

Record last verified: 2026-07

Locations

IN (1)