跳至主要内容
临床试验/NCT06705114
NCT06705114已完成不适用

Ultrasound Investigation of Tongue Movement During Mastication for Completely Edentulous Patients Rehabilitated by Mandibular Implant Retained Overdenture

Mansoura University1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2023年10月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
15
试验地点
1
主要终点
ultrasound investigation of tongue movement

研究概览

简要总结

This study aimed to examine the impact of mandibular implant overdentures on tongue movement during mastication.

详细描述

Each patient received a newly constructed conventional complete denture. To construct the radiographic stent, the mandibular denture was duplicated in clear acrylic resin and modified by placing multiple holes filled with radiopaque gutta-percha points. A stereolithographic surgical guide was then constructed using a dual scan technique with cone beam computerized tomography (CBCT, i-CAT Vision®, Imaging Sciences International, Hatfield, PA). Two dental implants were inserted in the patient's mandibular arch at the canine region using guided surgery and a delayed loading protocol. Patients were instructed to rinse their mouth with Chlorohexidine mouthwash just before the implant surgery and continue for one week. A prophylactic antibiotic (Amoxicillin and Clavulanic acid 125 mg) was administered one hour before the surgery and continued for one week after surgery. To control pain, a nonsteroidal anti-inflammatory drug (Ibuprofen 600 mg) was prescribed. After surgery, patients were prohibited from using the complete denture and were advised to follow a soft diet.

After one week, the mandibular denture was relieved and relined with soft relining material (Softliner; PROMEDICA) and delivered to the patient. After 3-4 months, the dental implants were exposed and ball abutments were screwed into the implants (Fig.1A). The housing of the ball attachments were incorporated into the fitting surface of the mandibular denture using a direct pick-up technique (Fig. 1B). The mandibular overdenture was then inserted into the patient's mouth and occlusal adjustment was done using articulating paper to remove any occlusal interferences. Follow-up visits were scheduled.

Tongue movement measurement The evaluation of tongue movement was conducted using an ultrasound imaging system (Toshiba Medical Systems Corporation, Tokyo, Japan) with a 3.1-MHz convex probe. A layer of ultrasound jelly (Sono Jelly, Toshiba Medical Systems Corporation) was applied to the patient's skin under the probe. The patient was instructed to sit in upright position, and the probe was placed under the chin area to allow the beam to pass through the distal surfaces of the second premolars on both the right and left sides. The probe was secured in place using a microphone stand (Panasonic System Networks Co., Ltd., Tokyo, Japan) with adjustable height and angle. The position of the tongue was confirmed on the B-mode image of the sagittal plane, which provided a two-dimensional recording of the slice through the oral cavity. The recording rate was 0.0476 seconds (21 frames per second). Ultrasound images were taken while the patient chewed 1/4 of a cookie in a normal manner until it was swallowed.

The ultrasound images were taken at two different oral conditions: 3 months after complete denture insertion and 3 months after mandibular implant overdenture insertion. The ultrasound data were exported from the imaging system via a USB port and transferred to a personal computer. The Articulate Assistant Advanced (AAA) software program version 221.2.0 was used to analyze the data. The software program provides a measurement fan, which is used to automatically set control points at the intersection of the tongue-surface spline and each radial axis. This is done using the AAA edge-detection algorithm, which detects dark-bright discontinuities in the image. (28) The spline was then fitted to the visible surface of the tongue in each relevant video frame (Fig. 2). From the start time (the beginning of mastication) to the end time (when the tongue moved up towards the palate at the start of swallowing), the tongue surface was traced in AAA.

The following items were measured:

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
50 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •All patients were completely edentulous for at least one year, had a normal maxillo-mandibular relationship, and had available inter-arch space. They were nonsmokers and free from any systemic diseases that could affect implant osseointegration

排除标准

  • •Patients with head and neck surgery, skeletal deformity, and temporomandibular joint disorder were excluded from the study.

研究组 & 干预措施

group I: complete dentures

Active Comparator

Each patient received a newly constructed conventional complete denture.

干预措施: complete denture (Procedure)

group II: mandibular implant overdenture

Active Comparator

Two dental implants were inserted in the patient's mandibular arch at the canine region using guided surgery and a delayed loading protocol.

干预措施: implant overdenture (Procedure)

结局指标

主要结局

ultrasound investigation of tongue movement

时间窗: after 3 months of denture and overdenture insertion

The evaluation of tongue movement was conducted using an ultrasound imaging system (Toshiba Medical Systems Corporation, Tokyo, Japan) with a 3.1-MHz convex probe. A layer of ultrasound jelly (Sono Jelly, Toshiba Medical Systems Corporation) was applied to the patient's skin under the probe. The patient was instructed to sit in upright position, and the probe was placed under the chin area to allow the beam to pass through the distal surfaces of the second premolars on both the right and left sides. The probe was secured in place using a microphone stand (Panasonic System Networks Co., Ltd., Tokyo, Japan) with adjustable height and angle. The position of the tongue was confirmed on the B-mode image of the sagittal plane, which provided a two-dimensional recording of the slice through the oral cavity. The recording rate was 0.0476 seconds (21 frames per second). Ultrasound images were taken while the patient chewed 1/4 of a cookie in a normal manner until it was swallowed.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验