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Completed

NCT Number: NCT07736287

Fucoidan(Seaweed) Based Gel Around Immediate Implants

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.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Krishnadevaraya college of dental sciences and hospital

Bangalore, Karnataka, 562157, India

About this study

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.

  • test group(immediate implant+ fucoidan gel)
  • control group (only immediate implant without any gel)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Fucoidan extracted from F. Vesiculosus

Drug

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

Immediate Implant Placement

Procedure

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

Primary outcomes

  1. wound healing index after immediate implant placement

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

    Landry, Turnbull and Howley wound healing index

Secondary outcomes

  1. crestal bone level

    Time frame: baseline, 3month and 6 month

    using RVG with 1 mm grid

  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

Sponsors and collaborators

Lead sponsor

Krishnadevaraya College of Dental Sciences & Hospital

Other

Registry information

Official study title

Clinical And Radiographic Evaluation Of Fucoidan Gel Around Immediate Implants - A Randomized Control Trial

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Jul 30, 2026
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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