Immediate Implant
Conditions
Keywords
Silk fibroin with collagen membrane
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.
Interventions
OTHERcollagen 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
OTHERcross 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.
Sponsors
Krishnadevaraya College of Dental Sciences & Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To assess wound healing, gingival thickness and keratinized tissue width | pre implant placement , 6 weeks , 12 weeks | Gingival tissue thickness assessment will be done at the site of implant placement 1.5 mm below the gingival margin of adjacent tooth. Local anaesthesia will be administered before the procedure and an Endodontic K-file with silicone disc stop will be used to measure. The depth will be measured with UNC-15 probe. Apico-coronal width of keratinized tissue is measured as the distance from the mucogingival junction to the gingival margin, with the mucogingival junction determined using Schiller's Potassium Iodide Solution. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Radiovisiography with grid | pre implant placement , 6 weeks , 12 weeks | assess increase in bone volume |
Countries
India
Contacts
Primary Contactjyoti naik, bds
Backup ContactMLV Prabhuji, mds
Outcome results
None listed