Wound HealingPhase 3NCT07736287
Fucoidan(Seaweed) Based Gel Around Immediate Implants
A Phase 3 study testing Fucoidan extracted from F. Vesiculosus and immediate implant placement in people with Wound Healing and Bone Regeneration, run by Krishnadevaraya College of Dental Sciences & Hospital at 1 site in India.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Wound Healing, Bone Regeneration
- What is being tested?
- Fucoidan extracted from F. Vesiculosus and immediate implant placement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIndia
- Study dates
- 11 May 2025to 5 Jul 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
India1 site
Krishnadevaraya college of dental sciences and hospital
Bangalore, Karnataka, 562157
About this study
Official title: Clinical And Radiographic Evaluation Of Fucoidan Gel Around Immediate Implants - A Randomized Control Trial
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.
- test group(immediate implant+ fucoidan gel)
- control group (only immediate implant without any gel)
- Conditions
- Wound Healing, Bone Regeneration
- Being tested
- Fucoidan extracted from F. Vesiculosus, immediate implant placement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fucoidan extracted from F. VesiculosusDrug
patients with immediate implant with Fucoidan gel coating prior to implant placement
immediate implant placementProcedure or surgery
patients with immediate implant without any implant surface coating prior to implant placement
| Study group | Role | What they receive |
|---|---|---|
| fucoidan gel | Active comparator | Patients with immediate implant with Fucoidan gel implant surface coating prior to implant placement. Receives: Drug: Fucoidan extracted from F. Vesiculosus |
| without any gel | Experimental | Patients with immediate implant without any implant surface coating prior to implant placement. Receives: Procedure: immediate implant placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
wound healing index after immediate implant placement
Landry, Turnbull and Howley wound healing index
Measured: 7th day,14th day, 21st day, 1month, 3months and 6 months
Secondary outcomes (8)
crestal bone level
using RVG with 1 mm grid
Measured: baseline, 3month and 6 month
gingival tissue thickness
Measured: baseline , 3months and 6 months
keratinised tissue width
Measured: baseline,3months and 6 months
CBCT : linear measurement
Measured: baseline and 6months
Plaque Index
Measured: 3months
Gingival Index
Measured: 3months
Modified sulcular bleeding index
Measured: 3 months
Probing depth (PD)
Measured: 1month,3month and 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2026
- Study start11 May 2025
- Primary completion5 Nov 2025
- Study completion5 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound HealingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- life extension potimised fucodian capsules was used for this study
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Krishnadevaraya College of Dental Sciences & Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Prabhuji MLV, Krishnadevaraya College of Dental Sciences & Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07736287
- Sponsor's protocol ID
- KCDSHEC/IP/2025/43
- Status last verified
- Jul 2026
- First submitted
- 20 Jul 2026
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical And Radiographic Evaluation Of Fucoidan Gel Around Immediate Implants - A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT07736287
- Acronym / sponsor ID
- KCDSHEC/IP/2025/43
- Conditions
- Wound Healing, Bone Regeneration
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Krishnadevaraya College of Dental Sciences & HospitalUniversity, hospital or other
- Study start
- 11 May 2025 (actual)
- Primary completion
- 5 Nov 2025 (actual)
- Study completion
- 5 Jul 2026 (actual)
- First posted
- 30 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
- test group(immediate implant+ fucoidan gel)
- control group (only immediate implant without any gel)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- life extension potimised fucodian capsules was used for this study
| Arm | Type | Receives |
|---|---|---|
| fucoidan gel | Active comparator | Drug: Fucoidan extracted from F. VesiculosusPatients with immediate implant with Fucoidan gel implant surface coating prior to implant placement. |
| without any gel | Experimental | Procedure: immediate implant placementPatients with immediate implant without any implant surface coating prior to implant placement. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fucoidan extracted from F. Vesiculosuspatients with immediate implant with Fucoidan gel coating prior to implant placement | Drug | fucoidan gel |
| immediate implant placementpatients with immediate implant without any implant surface coating prior to implant placement | Procedure or surgery | without any gel |
Primary outcome
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
8 secondary outcomes
crestal bone level
Time frame: baseline, 3month and 6 month
gingival tissue thickness
Time frame: baseline , 3months and 6 months
keratinised tissue width
Time frame: baseline,3months and 6 months
CBCT : linear measurement
Time frame: baseline and 6months
Plaque Index
Time frame: 3months
Gingival Index
Time frame: 3months
Modified sulcular bleeding index
Time frame: 3 months
Probing depth (PD)
Time frame: 1month,3month and 6 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fucoidan extracted from F. Vesiculosus and immediate implant placement in people with Wound Healing and Bone Regeneration, run by Krishnadevaraya College of Dental Sciences & Hospital at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
wound healing index after immediate implant placement (time frame: 7th day,14th day, 21st day, 1month, 3months and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.