Comparative evaluation of the bone regeneration with and without use of 3d scaffold matrix in adult patients in defects following intra-alveolar extraction of mandibular molars – An Observer Blind Prospective Randomized Controlled Study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- To evaluate and compare the defect fill and alveolar crest resorption along with height and width of the residual alveolar ridge at the site of extraction of mandibular molars by means of CBCT following extraction in adult participants with and without the use of 3D scaffold matrix
研究概览
简要总结
Alveolar Bone resorption is an inevitable consequence of tooth extraction. The basic premise of ridge healing mechanisms post extraction have clearly led to overall volumetric reduction in both horizontal (2.46 to 4.56mm) and vertical (0.8 to 1.5 mm) dimensions averaging up to 50% within 12 months, two thirds of which occurs within the first three months (Lang et al). Socket preservation techniques have always aimed to neutralize these early dimensional changes and maintain the ridge volumes within the envelope at the time of extraction. This is particularly relevant in cases where immediate or early implant placement as socket preservers is not feasible. Advances in biomaterials, and research unravelling the molecular mechanisms of alveolar bone resorption have led to the advent of multiple options ranging from autografts, xenografts, allografts and alloplastic bone substitutes. Factors which have been considered when selecting the appropriate choice have been the site and size of defect, healing time, evidence for safety and effectiveness, price of the graft, and availability of the graft material. The market demand for Alloplast is bound to grow rapidly over other modalities because of various advantages like no risk of transmission of infection, unlimited availability and avoidance of donor site morbidity and slower degradation. The alloplast is segmented into allograft & synthetic materials. The allografts segment includes demineralized bone matrix and others, whereas the synthetic segment is further broken down into ceramic, composite, polymers, and Bone Morphogenic Proteins (BMP). A good blend of osteoconductive, osteoinductive, osteopromotive and osteogenic properties have always governed the performance of these materials and outcomes. Alloplasts also may carry the advantage of being 3 D printable to match the defect in size, shape and volume for customization. While many materials and techniques have been studied to prevent post extraction resorption, none of the currently used techniques provides complete efficacy in terms of time required for regeneration, ridge preservation dimensionally and quality of regenerate. The use of growth factors and tissue engineering concepts is still in its nascent stage and, while promising, requires more clinical trials before we arrive at an economically viable, resorbable, biologically effective and an option amenable to 3 D printing as a one stop solution. Thus a novel three dimensional (3D) scaffold has been developed with the unique combination of nano hydroxyapatite/ gelatin/ carboxymethyl cellulose (nano Hydroxyapetite/ gelatin /Carboxy Methyl Cellulose) for bone tissue engineering by using the solvent-casting method combined with vapor-phase crosslinking and freeze-drying. The aim of this study is to evaluate the potential of absorbable nano Hydroxyapetite /gelatin/ Carboxy Methyl Cellulose as a scaffold to enhance bone formation in defects generated following a Mandibular Molar extraction in Human adults.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •a) Participants undergoing dental extraction of Mandibular 1st or 2nd molars.
- •b) Participants within age group from 18-60 years of either gender.
- •c) Participants willing to be followed up for 12 weeks.
- •d) Participants willing to undergo Dental Implant placement following extraction of the Mandibular Molar at 12 weeks post extraction.
排除标准
- •a) Participants demonstrating periapical infection/ osteomyelitis/ tissue space infection in association with the Mandibular molar indicated for extraction.
- •b) Teeth which require trans-alveolar method of extraction under local anaesthesia c) Lone standing Mandibular first or second molars indicated for extraction.
- •d) Patients suffering from systemic disease like diabetes mellitus, osteoporosis, auto immune diseases and on Medications which are proven to affect bony wound healing.
- •e) Female patients who are pregnant.
- •f) Participants indicated for Mandibular third molar extractions.
结局指标
主要结局
To evaluate and compare the defect fill and alveolar crest resorption along with height and width of the residual alveolar ridge at the site of extraction of mandibular molars by means of CBCT following extraction in adult participants with and without the use of 3D scaffold matrix
时间窗: Baseline and 12 weeks
次要结局
- Primary objective 2- To evaluate & compare the bony(regenerate in the extraction socket at 12 weeks for Bone)
- Primary objective 3- To evaluate & compare the(Histomorphometry of the bony regenerate in the extraction socket at 12 weeks post extraction for presence or absence of Woven bone, Lamellar bone, Nonviable)
- To evaluate and compare the socket wound healing at 3 days and(7 days following extraction with and without use of 3D Scaffold)
研究者
Gaury Agrawal
MGM Dental College and Hospital Kamothe
