Clinical trial NCT06552065: Evaluation of Cross-linked Collagen Membrane With and Without Silk Fibroin Around Immediate Dental Implants
Official title: Comparative Evaluation of Cross-linked Collagen Membrane With and Without Silk Fibroin Around Immediate Dental Implants -Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Immediate Implant
Keywords: Silk fibroin with collagen membrane
Lead sponsor: Krishnadevaraya College of Dental Sciences & Hospital
Sponsor class: OTHER
First posted: 2024-08-13
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Comparative evaluation of cross-linked collagen membrane with and without silk fibroin around Immediate Dental Implants -Randomized controlled trial.

Detailed description: Periodontal disease is an inflammatory and infectious disease affecting the tooth supporting structures leading to tooth loss when left untreated.The detrimental effect of periodontitis results in soft tissue and hard tissue loss. Bone defects has often resulted from tumor resection, congenital malformation, trauma, fractures, surgery, periodontitis or around implants in dentistry, as well as from diseases, such as osteoporosis or arthritis.These deficiencies have been overcome through various treatment modalities.It is a well-established fact that the cells from the periodontal ligament have the potential for regeneration of the tooth attachment apparatus. In addition, bone grafts and membranes have been used to regenerate the lost bone.

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.

Eligibility criteria: Inclusion Criteria

* Systemically healthy patients in the age group of 18 to 55years.
* 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:

* Patients having allergies with collagen and silk products.
* 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.

Primary outcomes:
measure: To assess wound healing, gingival thickness and keratinized tissue width
timeFrame: pre implant placement , 6 weeks , 12 weeks
Secondary outcomes:
measure: Radiovisiography with grid
timeFrame: pre implant placement , 6 weeks , 12 weeks
Other outcomes:
Locations:
city: Bangalore
country: India
facility: Krishnadevaraya college of dental sciences
state: Karnataka
Study officials:
References:
citation: 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.