Clinical And Radiographic Evaluation Of Fucoidan Gel Around Immediate Implants - A Randomized Control Trial
| Registry | NCT07736287 |
|---|---|
| Status | Completed |
| Phase | Phase 3 |
| Study type | Interventional; randomized, parallel, masking: none, treatment |
| Enrollment | 20 (Actual) |
| Sponsor | Krishnadevaraya College of Dental Sciences & Hospital (Other) |
| Conditions | Wound Healing, Bone Regeneration |
| Interventions | Fucoidan extracted from F. Vesiculosus, immediate implant placement (Drug, procedure) |
| Dates | start 2025-05-11, primary completion 2025-11-05, completion 2026-07-05, first posted 2026-07-30, last updated 2026-07-30 |
| Locations | 1 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
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.
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)
| Arm | Type | Interventions | Description |
|---|---|---|---|
| fucoidan gel | Active comparator | Drug: Fucoidan extracted from F. Vesiculosus | Patients with immediate implant with Fucoidan gel implant surface coating prior to implant placement. |
| without any gel | Experimental | Procedure: immediate implant placement | Patients with immediate implant without any implant surface coating prior to implant placement. |
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.
| Facility | City | Country | Status |
|---|---|---|---|
| Krishnadevaraya college of dental sciences and hospital | Bangalore, Karnataka | India |