跳至主要内容
临床试验/CTRI/2024/05/068192
CTRI/2024/05/068192尚未招募Phase 3 4

Comparative Evaluation of Effectiveness of Demineralized Freeze-Dried Bone Allografts (DFDBA) with Titanium Platelet Rich Fibrin (T-PRF) and Autologous Dentin Graft (ADG) with T-PRF in Alveolar Socket Preservation: A Randomised Control Trial.

Sharad Pawar Dental College Sawangi Meghe Wardha1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2024年7月1日最近更新:

试验速览

阶段
Phase 3 4
状态
尚未招募
发起方
入组人数
16
试验地点
1
主要终点
radiographic analysis, we will access new bone formation, change in sockets vertical alveolar bone

研究概览

简要总结

AIM - assess and compare the effectiveness of DFDBA with T-PRF and ADG with T-PRF in socket preservation using clinical, radiological and histomorphometric analysis.

OBJECTIVES- Comparison of the effectiveness of DFDBA with T-PRF and ADG and T-PRF in alveolar ridge preservation therapy in terms of the quantity of newly formed bone and residual graft material that is histologically retained after four months of healing.

METHODOLOGY- Sixteen patients having teeth indicated for extraction in maxilla and /or mandiblewill be selected. Eight patients in test group and eight patients in control group will be alloted. In test group ADG and T-PRF will be used and in control group DFDBA + T-PRF will be used.

EXPECTED OUTCOME

T-PRF along with Autologous dentin graft will lead to better radiographic bone fill and improved intrasocket measurements after 4 months of surgery.

CONCLUSION- The socket preservation procedure have been proven to be effective in maintaining the ridge dimensions after extractions.

socket preservation using ADG+ T-PRF may result in maintaing the alveolar ridge dimensions.

M

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Patients indicated for implant following extraction.
  • Because of reasons like, fracture of root, failure of endodontic treatment, resorption (internal and external), over-retained primary teeth, non-restorable carious lesions, residual roots.
  • A complete mouth plaque score of less than 25% indicates good oral hygiene.
  • Existence of a natural tooth in opposition 4) Adjacent teeth presence 5) Thick gingival biotype 6) The clinical and radiological appearance of the unbroken alveolar bone walls 7) 4 mm of bone radiographically at root apex 8) D-1, D-2 or D-3 bone quality.

排除标准

  • Patients with impaired systemic health that would interfere with the process involved with repair and healing of bones e.g. (Diabetes mellitus, Osteoporosis, Blood disorders, and Titanium allergy).
  • Significant differences in maxilla-mandibular space.
  • Presence of para functional habits such as bruxism or clenching.
  • Presence of proclined teeth, teeth with interdental spacing, rotated or mal-aligned anterior teeth.
  • History of alcoholism, excessive smoking or drug abuse.
  • D-4 bone quality.
  • Radiotherapy and chemotherapy history.
  • Debilitating tempro-mandibular joint pathosis.
  • Untreated dental diseases.
  • Pregnant and lactating mothers.

结局指标

主要结局

radiographic analysis, we will access new bone formation, change in sockets vertical alveolar bone

时间窗: four months post operatively

次要结局

  • The main results are linear phenotypic dimensional changes, at baseline & four months after healing at two locations in the midfacial & midpalatal bone & soft tissue thickness.(After four months of surgery)

研究者

发起方
Sharad Pawar Dental College Sawangi Meghe Wardha
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Shivani Prafulla Thakre

Sharad Pawar Dental College, Sawangi (Meghe)

研究点 (1)

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