Evaluation of Cross-linked Collagen Membrane With and Without Silk Fibroin Around Immediate Dental Implants

Krishnadevaraya College of Dental Sciences & Hospital

Status: Not yet enrolling

Conditions: Immediate Implant

Treatments: Other: cross linked collagen membrane; Other: collagen with silk fibroin membrane

Study type: Interventional

Funder types: Other

Identifiers

NCT06552065

02-D012-00050

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

20 participants in 2 patient groups

10 will receive cross -linked collagen with silk fibroin membrane around immediate implant.

Experimental group

Description:

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.

Treatment:

Other: collagen with silk fibroin membrane

Other: cross linked collagen membrane

10 will receive cross linked collagen membrane around immediate implant

Active Comparator group

Description:

Local anesthesia is given. Atraumatic extraction is done. Osteotomy is done. Immediate implant is placed along with crosslinked collagen membrane. Suture is done.

Treatment:

Other: collagen with silk fibroin membrane

Other: cross linked collagen membrane