Evaluation of Cross-linked Collagen Membrane With and Without Silk Fibroin Around Immediate Dental Implants
NCT ID: NCT06552065
Last Updated: 2024-08-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
20 participants
INTERVENTIONAL
2024-09-30
2025-08-31
Brief Summary
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Detailed Description
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Among the membranes, autogenous connective tissue graft remains as gold standard. Collagen is biocompatible natural polymer that has a good function to promote new tissue formation. In the proposed study, immediate implants with compromised bone support, cross-linked bovine collagen membrane will be used. It is a naturally occurring protein, having excellent biocompatibility, and hemostatic and chemotactic characteristics for gingival fibroblasts and periodontal ligaments. Further, it is resistant to tension, controllable biodegradability, is non cytotoxic, low antigenicity, and excellent anti-inflammatory characteristics. It is naturally reabsorbed by microorganisms, easy to manipulate and has a molecular structure with little variance concerning the animal from which the collagen is extracted, leading to improved immunogenicity.
Bovine collagen is selected to enhance the biological function of silk fibroin, as composite membrane for enhancement of gingival thickness. Thus, considering all these characteristics, silk fibroin is incorporated into collagen membrane for evaluation .As there is no literature assessing this composite membrane, the aim of this study Compare evaluation of Cross-linked collagen membrane with and without Silk fibroin around Immediate Dental Implants Randomized controlled trial will be undertaken.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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10 will receive cross -linked collagen with silk fibroin membrane around immediate implant.
Local anesthesia is given. Atraumatic extraction is done. Osteotomy is done. Immediate implant is placed along with crosslinked collagen with silk fibroin membrane. Suture is done.
collagen with silk fibroin membrane
A mucoperiosteal flap will be raised and atraumatic extraction will be done. An immediate implant with collagen with silk fibroin membrane (experimental group) will be placed according to the standard protocol.
An immediate implant with collagen membrane ( comparative group) will be placed according to the standard protocol .
The surgical wound closure will be coapted with mattress and single interrupted sutures
cross linked collagen membrane
A mucoperiosteal flap will be raised and atraumatic extraction will be done. An immediate implant with collagen with silk fibroin membrane (experimental group) will be placed according to the standard protocol.
10 will receive cross linked collagen membrane around immediate implant
Local anesthesia is given. Atraumatic extraction is done. Osteotomy is done. Immediate implant is placed along with crosslinked collagen membrane. Suture is done.
collagen with silk fibroin membrane
A mucoperiosteal flap will be raised and atraumatic extraction will be done. An immediate implant with collagen with silk fibroin membrane (experimental group) will be placed according to the standard protocol.
An immediate implant with collagen membrane ( comparative group) will be placed according to the standard protocol .
The surgical wound closure will be coapted with mattress and single interrupted sutures
cross linked collagen membrane
A mucoperiosteal flap will be raised and atraumatic extraction will be done. An immediate implant with collagen with silk fibroin membrane (experimental group) will be placed according to the standard protocol.
Interventions
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collagen with silk fibroin membrane
A mucoperiosteal flap will be raised and atraumatic extraction will be done. An immediate implant with collagen with silk fibroin membrane (experimental group) will be placed according to the standard protocol.
An immediate implant with collagen membrane ( comparative group) will be placed according to the standard protocol .
The surgical wound closure will be coapted with mattress and single interrupted sutures
cross linked collagen membrane
A mucoperiosteal flap will be raised and atraumatic extraction will be done. An immediate implant with collagen with silk fibroin membrane (experimental group) will be placed according to the standard protocol.
Eligibility Criteria
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Inclusion Criteria
* Patients undergoing immediate implant placement with gingival thickness ≤ 1mm
* Stage II /Stage III and Grade B Periodontitis patients.
* Radiographic assessment using Radiovisiography (RVG) with grid.
Exclusion Criteria
* Medical conditions contraindicating surgical interventions.
* Known smokers and alcoholic.
* Acute infections at the site of extraction. Ex Abscess.
* Patients who have undergone radiotherapy or chemotherapy.
18 Years
55 Years
ALL
Yes
Sponsors
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Krishnadevaraya College of Dental Sciences & Hospital
OTHER
Responsible Party
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Locations
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Krishnadevaraya college of dental sciences
Bangalore, Karnataka, India
Countries
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Central Contacts
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References
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Pripatnanont P, Chankum C, Meesane J, Thonglam J. Physical and biological performances of a semi-resorbable barrier membrane based on silk fibroin-glycerol-fish collagen material for guided bone regeneration. J Biomater Appl. 2021 Nov;36(5):930-942. doi: 10.1177/08853282211025781. Epub 2021 Jun 21.
Other Identifiers
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02-D012-00050
Identifier Type: -
Identifier Source: org_study_id
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