Bone Regeneration, Wound Healing
Conditions
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.
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)
Interventions
patients with immediate implant with Fucoidan gel coating prior to implant placement
PROCEDUREimmediate implant placement
patients with immediate implant without any implant surface coating prior to implant placement
Sponsors
Krishnadevaraya College of Dental Sciences & Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
life extension potimised fucodian capsules was used for this study
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
Countries
India
Outcome results
None listed