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临床试验/NCT06728202
NCT06728202尚未招募不适用

A Horizontal Ridge Augmentation in Atrophic Maxillary Ridge: Evaluating Alveolar Ridge Splitting and Osseodensification

Fayoum University0 个研究点目标入组 46 人开始时间: 2024年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
46
主要终点
Gained bone width :

研究概览

简要总结

Evaluation of clinical and radiological outcomes of the alveolar ridge splitting technique versus Osseodensification burs in atrophic maxillary alveolar ridges in horizontal dimension.

详细描述

The success of dental implant procedures hinges not only on the expertise of the clinician but also on the quality and quantity of bone at the implant site.

The significance of bone parameters in determining the feasibility and long-term outcomes of dental implants cannot be overstated. Over the years, various classifications have been proposed to assess bone quality and quantity, each aiming to provide a comprehensive framework for clinicians to evaluate and plan implant placement effectively.

One of the seminal classifications widely utilized in clinical practice is (the Cawood and Howell classification)1,2,3, which categorizes edentulous ridges into six types based on the quantity and quality of residual bone. In this classification system class IV in maxilla has gained special interest as it provides the adequate length for implant insertion but the width is insufficient. That made lots of researchers come with lots of different solutions to save time,cost and provide the best results for the patient.

Computed tomography (CT) provides an objective means to quantify bone density, expressed in Hounsfield units (HU), as described by T. Misch. The HU derived from CBCT scans correspond to grayscale values. Through linear regression analysis, grayscale values can be subjectively determined from CBCT images by aligning CT images with the same points on CBCT scans. The regression equation used for this analysis was HU = -61.098 + 1.178 × grayscale.4,5,6,7,8

Horizontal bone defects pose significant challenges in dental implantology, often requiring innovative surgical techniques to achieve successful implant placement.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •I. Patients with atrophic maxillary alveolar ridges in horizontal dimension <18 years old. II. the bucco-palatal alveolar ridge dimension 2-4 mm III. a minimal vertical bone height of 10 mm

排除标准

  • •I. Bad oral hygiene. II. Patients with non healthy habits as (Smokers, Alcoholics, or drug abusers). III. Patients with any active periapical pathosis. IV. Patients treated with chemo or radiotherapy during the past 5 years. V. Acute and progressive periodontal disease. VI. Medically compromised patient not indicated for surgical procedures. VII. Patient with history of bleeding disorders. VIII. Patient with osteo-porotic disease.

研究组 & 干预措施

Alveolar ridge split group:

Active Comparator
  • a crestal incision and two vertical releasing incisions will be formed, followed by a full-thickness mucoperiosteal flap.
  • the flap will be raised to expose the whole length facial cortical bone.
  • The palatal mucoperiosteum will also be slightly reflected for better exposure of the crest of the alveolar ridge and free placement of the surgical guides.
  • the patient specific guides will be placed and fixed by monocortical osteosynthesis screws at the pre-planned positions at the labial cortical plate of bone , precisely locate the mid-crestal and two vertical stop cuts to improve the accuracy of the procedure, preventing bad splits with the aim of reducing the final marginal bone loss associated with this technique.
  • bony cut will be performed using a piezoelectric device on the facial aspect of alveolar ridge 1.5 mm away from the adjacent teeth or implants, extending 7 mm apically from the crest of the ridge.implants will be inserted in the osteotomy sites using torque-wrench

干预措施: A Horizontal Ridge Augmentation in Atrophic Maxillary Ridge (Procedure)

Implant placement in pristine bone with Osseodensification burs group:

Active Comparator
  • A crestal incision and two vertical releasing incisions will be formed, followed by a full-thickness mucoperiosteal flap
  • Implant osteotomies are being performed with the assistance of saline irrigation. The osteotomies will be performed at 800-1500 rpm in a counterclockwise direction (Densifying Mode) with the use of sequential burs of similar diameter (OD drilling burs) used with copious irrigation in a Bouncing-Pumping motion (minor vertical pressure to advance the drill into the osteotomy, then pull out for pressure relief, then advance with vertical pressure again and so on in an in/out fashion). the instrumentation will be performed according to the recommended drilling protocols for Densah® Burs implant system; either by standard drilling, as recommended by implant company protocols.
  • The insertion of the implants will be initiated with the motor handpiece, without irrigation at 20-50 rpm, and installation will be completed with a manual surgical torque wrench

干预措施: A Horizontal Ridge Augmentation in Atrophic Maxillary Ridge (Procedure)

结局指标

主要结局

Gained bone width :

时间窗: preoperative , immediate postoperative and 6 months postoperative.

will be measured immediately after surgery by CBCT using the following reference points: 1. Ridge width (RW): the distance between the buccal and palatal border of the bone at the crest. 2. Buccal bone thickness (BBT): the distance from the implant surface to the outer margin of bone. All variables will be measured twice with an interval of 1 week between measurements.

次要结局

  • primary stability:(immediately and 6 months post-operative)
  • Bone density :(Immediate post operative and 6 months postoperative)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Islam Wesam Saied Sayed

Administrative Dentist at Oral and Maxillofacial surgery department - Faculty of Dentistry at Fayoum University

Fayoum University

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