Fucoidan(Seaweed) Based Gel Around Immediate Implants

NCT07736287 — Phase 3, Completed, 20 participants, Krishnadevaraya College of Dental Sciences & Hospital

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

RegistryNCT07736287
StatusCompleted
PhasePhase 3
Study typeInterventional; randomized, parallel, masking: none, treatment
Enrollment20 (Actual)
SponsorKrishnadevaraya College of Dental Sciences & Hospital (Other)
ConditionsWound Healing, Bone Regeneration
InterventionsFucoidan extracted from F. Vesiculosus, immediate implant placement (Drug, procedure)
Datesstart 2025-05-11, primary completion 2025-11-05, completion 2026-07-05, first posted 2026-07-30, last updated 2026-07-30
Locations1 site in India

Related Papers Related Patents Related Grants Related Experts
All trials for Wound Healing All trials for Bone Regeneration All trials of Fucoidan extracted from F. Vesiculosus All trials of immediate implant placement

-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.

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+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)

+Arms and interventions

ArmTypeInterventionsDescription
fucoidan gelActive comparatorDrug: Fucoidan extracted from F. VesiculosusPatients with immediate implant with Fucoidan gel implant surface coating prior to implant placement.
without any gelExperimentalProcedure: immediate implant placementPatients with immediate implant without any implant surface coating prior to implant placement.
  • 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

+Outcome measures

Primary outcomes

  • wound healing index after immediate implant placement [7th day,14th day, 21st day, 1month, 3months and 6 months]: Landry, Turnbull and Howley wound healing index

Secondary outcomes

  • crestal bone level [baseline, 3month and 6 month]: using RVG with 1 mm grid
  • 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]
  • Gingival Index [3months]
  • Modified sulcular bleeding index [3 months]
  • Probing depth (PD) [1month,3month and 6 month]

+Eligibility

Sex: All, ages: 18 Years to 50 Years, accepts healthy volunteers

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:

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.

+Locations (1)

FacilityCityCountryStatus
Krishnadevaraya college of dental sciences and hospitalBangalore, KarnatakaIndia