Radiographic Assessment of Bone Dimension Around Immediate Implants With FDBA and I-PRF vs FDBA Alone- A Randomized Clinical Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Bone fill
研究概览
简要总结
The present study is a human, prospective, parallel, randomised controlled clinical trial conducted for radiographic assessment of bone dimension around immediate implants with FDBA and I-PRF vs FDBA Alone The trial is in accordance with the Consolidated Standards of Reporting Trials (CONSORT) criteria, 2010.
详细描述
Twenty healthy individuals satisfying the inclusion and exclusion criteria were recruited for the study. A detailed, thorough medical and dental history was obtained and each patient was subjected to comprehensive clinical and radiological examination. All patients were informed about the nature of the study, the surgical procedure involved, potential benefits and risks associated with the surgical procedure and written informed consent were obtained from all patients. All the patients were treated with immediate implants in endodontically and periodontically compromised sites. FDBA graft along with I-PRF is combined to form a sticky bone, this stable element is placed around the implants where bone is compromised.
The clinical and radiographic parameters were recorded at baseline, three months and six months postoperatively
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
- Single (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
- •Patients between 18-55 years of age.
- •Presence of non-restorable single rooted teeth (maxillary or mandibular) due to trauma, caries, root resorption, root fracture, endodontic or periodontal failure.
- •Grade I or Grade II extraction socket according to El Chaar et al
- •Good oral hygiene.
- •Good patient compliance.
排除标准
- •Systemic complications (uncontrolled diabetes and severe cardiovascular or infectious diseases).
- •Intravenous and oral bisphosphonate therapy.
- •Patients who are psychologically unable to participate.
- •Pregnant patients, patients with bone diseases and patients on chemotherapy or radiotherapy, alcohol or drug abuse.
- •Patients with hemorrhagic disorders.
结局指标
主要结局
Bone fill
时间窗: At baseline, 3 months and 6 months
Standard digital radiographs were taken at baseline, 3 months and 6 months by paralleling/long-cone technique. Radiographic images at all the time intervals were taken by using a metallic counting grid (IOPA film grid® , BlueDent, Chennai, India). The bone-fill was measured in square millimeters by point-counting the number of squares over newly developing radiopacities at different follow up periods. Squares that were half filled or unclear were not counted.
Bone dimensions
时间窗: At baseline, 3 months and 6 months
The sites will be assessed vertically and horizontally by CBCT images taken at baseline and 6 months after the implant placement.
Bone density
时间窗: At baseline, 3 months and 6 months
Bone mineral density is obtained by the CBCT (GENORAY (PAPAYA 3D premium operation software)
Marginal bone level
时间窗: At baseline, 3 months and 6 months
distance between reference point(the implant shoulder) and the first marginal bone-to-implant contact level using standard digital radiographs
Early wound healing index
时间窗: At baseline, 3 months and 6 months
SCORE 1: COMPLETE FLAP CLOSURE NO FIBRIN LINE IN THE INTERPROXIMAL AREA SCORE 2: COMPLETE FLAP CLOSURE FINE FIBRIN LINE IN THEINTERPROXIMAL AREA SCORE 3: COMPLETE FLAP CLOSURE FIBRIN CLOT IN THE INTERPROXIMAL AREA SCORE 4:INCOMPLETE FLAP CLOSURE PARTIAL NECROSIS OF THE INTERPROXIMAL AREA SCORE 5: INCOMPLETE FLAP CLOSURE COMPLETE NECROSIS OF THE INTERPROXIMAL AREA. SCORE 1: COMPLETE FLAP CLOSURE NO FIBRIN LINE IN THE INTERPROXIMAL AREA SCORE 2: COMPLETE FLAP CLOSURE FINE FIBRIN LINE IN THEINTERPROXIMAL AREA SCORE 3: COMPLETE FLAP CLOSURE FIBRIN CLOT IN THE INTERPROXIMAL AREA SCORE 4:INCOMPLETE FLAP CLOSURE PARTIAL NECROSIS OF THE INTERPROXIMAL AREA SCORE 5: INCOMPLETE FLAP CLOSURE COMPLETE NECROSIS OF THE INTERPROXIMAL AREA. Wachet et al wound healing index will be used for obtaining the healing index
次要结局
- GINGIVAL INDEX(3 months and 6 months)
- GINIVAL BLEEDING INDEX(3 months and 6 months)
研究者
Dr Prabhuji MLV
HOD OF PERIODONTOLOGY
Krishnadevaraya College of Dental Sciences & Hospital