Ultrasound Investigation of Tongue Movement for Implant Overdenture

NCT06705114 | Completed

• 1 other identifier: A01010023RP
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Prosthesis Durability

Keywords

Mastication; implant; mandibular; ultrasound; tongue movement

Outcome Measures

Primary Outcomes (1)

• ultrasound investigation of tongue movement

  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

Study Arms (2)

group I: complete dentures

ACTIVE COMPARATOR

Each patient received a newly constructed conventional complete denture.

Procedure: complete denture

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.

Procedure: implant overdenture

Interventions

complete denture PROCEDURE

Each patient received a newly constructed conventional complete denture with optimal denture extension and lingualized balanced occlusal concept

group I: complete dentures

implant overdenture PROCEDURE

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.

group II: mandibular implant overdenture

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

faculty of dentistry, mansoura university Mansoura, Egypt,

Al Mansurah, 35516, Egypt

Location

Related Publications (1)

• Goncalves GSY, de Magalhaes KMF, Rocha EP, Dos Santos PH, Assuncao WG. Oral health-related quality of life and satisfaction in edentulous patients rehabilitated with implant-supported full dentures all-on-four concept: a systematic review. Clin Oral Investig. 2022 Jan;26(1):83-94. doi: 10.1007/s00784-021-04213-y. Epub 2021 Oct 13.

  PMID: 34647147 RESULT

MeSH Terms

Conditions

Prosthesis Failure

Interventions

Denture, Complete

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dentures; Dental Prosthesis; Prosthodontics; Dentistry; Prostheses and Implants; Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2024
• First Posted: November 26, 2024
• Study Start: October 20, 2023
• Primary Completion: July 20, 2024
• Study Completion: September 20, 2024
• Last Updated: November 26, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)