NCT04239378Unknown不适用
Clinical, Radiographic and Histomorphometric Comparison of Autogenous Demineralized Dentin Matrix Versus Bovine-Derived Xenograft for Socket Preservation: A Randomised Controlled Clinical Trial
Krishnadevaraya College of Dental Sciences & Hospital2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2019年12月10日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Height of Alveolar Crest and Bucco-Lingual Ridge Width
研究概览
简要总结
The present study is a human, prospective, randomised controlled clinical trial will be conducted to explore and compare the clinical, radiographic and histomorphometric outcome of autogenous demineralised dentin(DDM) versus bovine derived xenograft(DBM) for socket preservation procedure.
详细描述
- After local anesthesia a full thickness flap will be minimally reflected buccally and lingually around the tooth not exceeding 3mm apical to the alveolar crest.
- Tooth extraction will be performed using atraumatic extraction methods using Periotome.
- After extraction, the socket will be thoroughly curetted, inspected and irrigated with sterile saline solution.
- The socket satisfying the inclusion and exclusion criteria will be randomly allocated to either test or control group.
- Intra surgical measurements will be recorded.
- Socket preservation will be performed with either Demineralized dentin matrix DDM(TEST) or bovine derived xenograft DBM (CONTROL). Bone graft will be extended to the height of intra proximal bone.
- Collagen membrane will be placed over the grafted site extending approximately 3mm apical to buccal and lingual crest.
- Flaps will be approximated with sutures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Teeth indicated for extraction and subsequent implant placement
- •Age group of 18 to 55 years
- •Single rooted tooth indicated for extraction due to endodontic failure, caries or Fracture
- •Presence of >2 mm keratinized tissue to allow flap management
- •Extraction site should have adjacent tooth on either side
- •Systemically healthy patients
- •Class II or III extraction socket defects according to Hammerele and Jung(2008)
- •Full mouth plaque score(FMPS)<25% at baseline.(PI)
- •Full mouth bleeding score(FMBS)<25% at baseline. (BI)
排除标准
- •.Presence of dehiscence or fenestration in any of the socket, more than 50% of bone loss in any of the socket walls
- •Medical conditions contraindicating surgical interventions
- •Known smokers and alcoholics
- •Subjects with known bone metabolic disorders.(Pagets disease,fibrous dysplasia etc.)
- •Acute infections at the site of extraction. Eg , Abscess
- •History of malignancy
- •Patients who have undergone radiotherapy or chemotherapy
- •Periapical pathology such as granulomas, cyst, hypercementosis, ankylosis.
- •Pregnant and lactating women
- •Maxillary and mandibular 3rd molars.
结局指标
主要结局
Height of Alveolar Crest and Bucco-Lingual Ridge Width
时间窗: 6 Months
Using Mapping Caliper and (University of North Carolina) UNC- 15 PROBE Measured in mm
New Bone Formation % and Residual Bone Graft
时间窗: 6 MONTHS
HISTOMORPHOMETRIC
Alveolar Ridge Width Gain(ARWG) and Vertical Bone Height Gain(VBHG)
时间窗: 6 MONTHS
CBCT (Cone Beam Computer Tomography) measured in mm
次要结局
- Plaque Index(6months)
- Bleeding Index(6 months)
- Patient Reported Outcome Measures for Pain and Esthetics(6 months)
研究者
Dr Prabhuji MLV
PROFESSOR
Krishnadevaraya College of Dental Sciences & Hospital
研究点 (2)
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