跳至主要内容
临床试验/CTRI/2018/02/011699
CTRI/2018/02/011699招募中2/3 期

Radiographic evaluation of maxillary sinus floor height after direct maxillary sinus augmentation using β-tricalcium phosphate and platelet rich fibrin.

Sinhgad Dental College and Hospital1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2016年12月5日最近更新:

试验速览

阶段
2/3 期
状态
招募中
入组人数
12
试验地点
1
主要终点
a.Vertical distance from alveolar ridge crest to the inferior most point on the sinus floor pre-operatively

研究概览

简要总结

The rehabilitation of patients affected by posterior maxillary atrophy by the aid of implant-supported fixed prosthesis presents a challenge in many cases.  Frequently, the available residual alveolar ridge is insufficient for the placement of dental implants because of alveolar bone resorption, pneumatization of the maxillary sinus, or their combination.

Maxillary sinus floor augmentation is the treatment of choice when insufficient alveolar bone height prevents placement of dental implants in the posterior edentulous maxilla.  Maxillary sinus augmentation was first presented by Tatum in 1976.  Long term results showed that this technique can be an effective treatment option.

Grafting materials used in sinus floor augmentation procedure can be in the form of bone blocks (cancellous or corticocancellous) or bone particles.   Although autogenous bone is considered the gold standard because of its high biocompatibility and osteoinductive potential, its disadvantages include  extra surgical site, donor site morbidity, increased cost and total operation time.

To reduce the problems associated with autografts, many authors have advocated the use of bone substitutes such as demineralized freeze-dried bone allograft(DFDBA), mineralized freeze-dried bone allograft(FDBA), xenografts, hydroxyapatite preparations, calcium sulfate preparations, as well as growth factors embedded in different carrier materials to augment the floor of the maxillary sinus.

Amongst alloplasts, β-tricalcium phosphate (β-TCP) is a biocompatible       alloplast and is of the highest purity. β- TCP has a crystalline structure and its porosity provides optimal biologic properties, i.e., osteoconductivity and total resorbability. It has calcium to phosphate ratio of 1:1.5, with particle size ranging from 0.5 to 1.0 mm and resorbs progressively, releasing calcium and phosphate ions, which promote new bone formation within 3-6 months. It has found its multiple clinical applications in dentistry in the treatment of bone defects, ridge and socket preservations, and periodontal osseous defects including furcation defects.

Platelet rich fibrin (PRF) is an autologous preparation of concentrated platelets created by centrifugation of a patient’s blood.  The use of PRF during surgical procedure is a current treatment concept used to accelerate wound healing and tissue maturation.  It can be used directly as a clot or after compression as a strong membrane.

Aim:

To radiographically evaluate the newly formed bone after direct maxillary sinus floor augmentation using β-TCP and platelet rich fibrin (PRF).

Objectives:

1.     To evaluate distance from alveolar ridge crest to the inferior most point on the sinus floor pre-operatively.

2.    To evaluate distance from alveolar ridge crest to the raised sinus floor post-operatively after 5 months.

3.    To evaluate increase in height of alveolar ridge crest post-operatively after 5 months.

Sample size: 12

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Not Applicable

入排标准

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

入选标准

  • 1.Systemically healthy patients between the age group 18 – 65 years.
  • 2.Maxillary partial (unilateral or bilateral) edentulism involving the premolar/molar areas.
  • 3.Patients willing for placement of implant in maxillary edentulous posterior region.
  • 4.Patients presenting with moderately or severely atrophic posterior maxilla with vertical residual ridge height ≤ 5mm.
  • 5.Patients willing to participate and sign an informed consent.
  • 6.Patients who are compliant.

排除标准

  • 1.Patients who are systemically compromised.
  • 2.Smoking > 5 cigarettes per day during the 3 months preceding the study.
  • 3.Maxillary sinus pathology.
  • 4.Pregnant and lactating females.
  • 5.No untreated periodontal or periapical pathology especially with teeth adjacent to sinus floor.

结局指标

主要结局

a.Vertical distance from alveolar ridge crest to the inferior most point on the sinus floor pre-operatively

时间窗: a.Vertical distance from alveolar ridge crest to the inferior most point on the sinus floor pre-operatively | b.Distance from alveolar ridge crest to the raised sinus floor post-operatively after 5 months.

b.Distance from alveolar ridge crest to the raised sinus floor post-operatively after 5 months.

时间窗: a.Vertical distance from alveolar ridge crest to the inferior most point on the sinus floor pre-operatively | b.Distance from alveolar ridge crest to the raised sinus floor post-operatively after 5 months.

次要结局

未报告次要终点

研究者

申办方类型
Private medical college

研究点 (1)

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