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临床试验/NCT06520332
NCT06520332尚未招募不适用

Comparative Evaluation of the Clinical Efficacy of Short Implants With Standard-Length Implants Placed in Native/Augmented Bone of the Patients With a History of Periodontitis - A Randomised Controlled 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: 2024年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
20
试验地点
2
主要终点
The primary outcome that will be assessed is implant survival rate.

研究概览

简要总结

Periodontal disease , especially in its advanced stages , is one of the main cause for tooth loss .Tooth replacement options include dental implants , fixed partial denture , removable partial denture and complete dentures . Dental implants have become more common treatment for replacing missing teeth and aim to improve chewing efficiency, physical health and esthetic. Although conventional implants cannot be placed in every site due to resorption of the alveolar socket after extraction. Thus short implants can be used as an alternative . Hence, this study aims at comparing the clinical efficacy of short implants with standard length implants placed in native or augmented bone in patients with a history of periodontitis.

详细描述

Implant supported prosthesis have proven as an esthetic , functional restoration with long term predictability by re-establishing appearance , comfort and mastication .

Following extraction , the bony socket undergoes significant horizontal and vertical reduction . This 3D resorption of alveolar sockets after extraction often lead to limitations for implant placement . Severe ridge atrophy complicates rehabilitation of posterior edentulous regions . This lack of adequate bone necessitates additional reconstructive surgeries such as guided bone regeneration, vertical ridge augmentation , sinus floor elevation , block grafts , distraction osteogenesis and transposition procedures of the inferior alveolar nerve to allow anatomically sound placement of dental implants . These complex surgical procedures can result in intra-operative complications like infections of graft/membranes and it's exposure and post-operative complications such as swelling , pain , nerve disturbances with an associated increased reluctance of the patient to undergo them . Also these procedures, has significantly increased treatment duration, morbidity, risk of complications and costs.

Currently , alternative procedures to avoid these additional surgeries and the associated complications encourages the use of less invasive procedures such as short implants. Short implant placements can reduce morbidity and recovery time associated with bone augmentation procedures. Thus use of shorter dental implant has shown to be a plausible solution in cases of confined space , as well as those associated with unavoidable anatomical structures , such as lingual concavities or the maxillary sinus proximation which can be prone to surgical difficulties. Short implants offer a minimally invasive approach with ease of handling , reduced surgical invasiveness and low risk of trauma to vital structures . Evidence suggests that short implants could decrease implant failure , marginal bone loss , biological complications and improve patient satisfaction. The evidence from the literature must be interpreted with caution due to the variable protocols. Clinicians require a thorough comprehension of implant dentistry to achieve predictability.Thus there is a need for well designed RCT's analysing and comparing the clinical outcomes of short implants placed in native bone with long implants placed in native or augmented bone .

Thus, the aim of the current randomised controlled clinical trial (RCT) study will be to analyse the clinical efficacy of short implants (≤6 mm) and compare it with standard length implants (≥10mm) placed in native / augmented bone in patients with history of periodontitis.

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, Investigator)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age group - 18 years and above
  • Presence of >2 mm keratinised tissue to allow flap management.
  • Systemically healthy patients
  • The residual vertical bone height at the implant sites ranging from 6 to 9 mm for short implant placement ; > 9 mm for standard implant placement.
  • History of periodontitis

排除标准

  • Medical conditions contraindicating surgical interventions
  • Uncontrolled diabetes
  • Hemorrhagic disorders
  • Intravenous and oral bisphosphonate therapy.
  • Irradiation in head and neck
  • Pregnant and lactating women
  • Subjects with known bone metabolic disorders (paget's disease , fibrous dysplasia etc.)
  • Known smokers and alcoholics

结局指标

主要结局

The primary outcome that will be assessed is implant survival rate.

时间窗: 6 months

The primary objective of this randomised controlled clinical trial will be to compare the survival rate of short implants (≤ 6 mm ) and standard-length implants (≥ 10 mm) in patients with a history of periodontitis; through clinical and radiographic analysis.

次要结局

未报告次要终点

研究者

发起方
Krishnadevaraya College of Dental Sciences & Hospital
申办方类型
Other
责任方
Sponsor

研究点 (2)

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