An interventional study of collagen with silk fibroin membrane and cross linked collagen membrane in Immediate Implant, sponsored by Krishnadevaraya College of Dental Sciences & Hospital. Not yet recruiting at 1 site in India. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-13.
Sponsored by Krishnadevaraya College of Dental Sciences & Hospital · Not applicable, Interventional, and Treatment
Comparative evaluation of cross-linked collagen membrane with and without silk fibroin around Immediate Dental Implants -Randomized controlled trial.
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.
Krishnadevaraya College of Dental Sciences & Hospital is the lead sponsor of 51 studies on the registry; 13 are open to participants now.
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Exclusion Criteria:
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.
Other: collagen with silk fibroin membrane · Other: cross linked collagen membrane
Local anesthesia is given. Atraumatic extraction is done. Osteotomy is done. Immediate implant is placed along with crosslinked collagen membrane. Suture is done.
Other: collagen with silk fibroin membrane · Other: 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. 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
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.
To assess wound healing, gingival thickness and keratinized tissue width
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.
Time frame: pre implant placement , 6 weeks , 12 weeks
Radiovisiography with grid
assess increase in bone volume
Time frame: pre implant placement , 6 weeks , 12 weeks
Plan to share: No — Individual Participant Data will not be shared with other researchers.
This study is not yet recruiting, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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Krishnadevaraya College of Dental Sciences & Hospital