Ultrasound Investigation of Tongue Movement for Implant Overdenture

November 25, 2024 updated by: Mansoura University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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:

1 -Duration of Chewing: From time of food ingestion to the time of beginning of first swallowing.

2- Cumulative displacement of the tongue during Chewing: The distance (in mm) from the tongue surface spline to the anchor point (A) was measured along the radial fan lines at three different points: 30 degrees posterior (B), the center (C), and 30 degrees anterior (D) (Fig. 3). This measurement process was repeated for consecutive video frames. The sum of absolute change between consecutive frames for all measurement points was detected.

3- Tongue surface shape during chewing.

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Mansoura, Egypt, 35516
        • faculty of dentistry, mansoura university Mansoura, Egypt,

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: group I: complete dentures
Each patient received a newly constructed conventional complete denture.
Each patient received a newly constructed conventional complete denture with optimal denture extension and lingualized balanced occlusal concept
Active Comparator: group II: mandibular implant overdenture
Two dental implants were inserted in the patient's mandibular arch at the canine region using guided surgery and a delayed loading protocol.
Two dental implants were inserted in the patient's mandibular arch at the canine region using guided surgery and a delayed loading protocol.After 3-4 months, the dental implants were exposed and ball abutments were screwed into the implants. 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ultrasound investigation of tongue movement
Time Frame: 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.
after 3 months of denture and overdenture insertion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 20, 2023

Primary Completion (Actual)

July 20, 2024

Study Completion (Actual)

September 20, 2024

Study Registration Dates

First Submitted

November 22, 2024

First Submitted That Met QC Criteria

November 25, 2024

First Posted (Estimated)

November 26, 2024

Study Record Updates

Last Update Posted (Estimated)

November 26, 2024

Last Update Submitted That Met QC Criteria

November 25, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • A01010023RP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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