Evaluation of Cross-linked Collagen Membrane With and Without Silk Fibroin Around Immediate Dental Implants
- Conditions
- Immediate Implant
- Interventions
- Other: collagen with silk fibroin membraneOther: cross linked collagen membrane
- Registration Number
- NCT06552065
- Lead Sponsor
- Krishnadevaraya College of Dental Sciences & Hospital
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 20
Not provided
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 10 will receive cross -linked collagen with silk fibroin membrane around immediate implant. collagen with silk fibroin membrane 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. 10 will receive cross linked collagen membrane around immediate implant 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. 10 will receive cross -linked collagen with silk fibroin membrane around immediate implant. cross linked collagen membrane 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. 10 will receive cross linked collagen membrane around immediate implant collagen with silk fibroin membrane Local anesthesia is given. Atraumatic extraction is done. Osteotomy is done. Immediate implant is placed along with crosslinked collagen membrane. Suture is done.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Radiovisiography with grid pre implant placement , 6 weeks , 12 weeks assess increase in bone volume
Trial Locations
- Locations (1)
Krishnadevaraya college of dental sciences
🇮🇳Bangalore, Karnataka, India