Hyoid Displacement During Swallowing Function for Completely Edentulous Subjects

NCT06187181 | Completed

• 1 other identifier: A19061222
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

To investigate the effect of wearing mandibular implant retained overdentures on superior and anterior hyoid displacement during swallowing process.

Conditions

Prosthesis Durability

Keywords

Hyoid bone.; implant.; overdenture; swallowing.

Outcome Measures

Primary Outcomes (1)

• swallowing evaluation

  hyoid bone displacement evaluation by videofluriscopy

  after 3 months of denture or overdenture insertion

Study Arms (3)

G. I : Completely edentulous patients

PLACEBO COMPARATOR

videofluroscopy for completely edentulous patients

Radiation: videofluroscopy

G.II: patients with complete dentures

ACTIVE COMPARATOR

complete denture construction for edentulous patient and videofluroscopy evaluation

Procedure: implant overdenture; Radiation: videofluroscopy

G.III: patients with implant overdentures

ACTIVE COMPARATOR

construction of implant overdenture and videofluroscopy evaluation

Procedure: implant overdenture; Radiation: videofluroscopy

Interventions

implant overdenture PROCEDURE

. Videofluoroscopy swallowing evaluation was done using 10 ml of thin liquid bolus at three different oral conditions: Without dentures (WOD), with the conventional complete denture (CDs) and with mandibular implant retained overdenture (IODs).

G.II: patients with complete dentures; G.III: patients with implant overdentures

videofluroscopy RADIATION

videofluroscopy evaluation of swallowing function

G. I : Completely edentulous patients; G.II: patients with complete dentures; G.III: patients with implant overdentures

Eligibility Criteria

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

You may qualify if:

• free from any medical problems that may affect the osseointegration of the dental implants
• class I maxillomandibular relationship and free from any previous swallowing problems

You may not qualify if:

• participants with temporomandibular joint disorder,
• head and neck surgery,
• sleep apnea
• skeletal deformity

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Faculty of Dentistry, Mansoura University

Al Mansurah, 35516, Egypt

Location

Related Publications (2)

• Kern JS, Kern T, Wolfart S, Heussen N. A systematic review and meta-analysis of removable and fixed implant-supported prostheses in edentulous jaws: post-loading implant loss. Clin Oral Implants Res. 2016 Feb;27(2):174-95. doi: 10.1111/clr.12531. Epub 2015 Feb 9.

  PMID: 25664612 BACKGROUND

• Ibrahim AM, Elgamal M, Abdel-Khalek EA. Hyoid displacement during swallowing function for completely edentulous subjects rehabilitated with mandibular implant retained overdenture. BMC Oral Health. 2024 Aug 8;24(1):914. doi: 10.1186/s12903-024-04616-9.

  PMID: 39118020 DERIVED

MeSH Terms

Conditions

Prosthesis Failure

Condition Hierarchy (Ancestors)

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

Study Officials

• abdallah Ibrahim, PhD

  Mansoura university, Faculty of dentistry, prosthodontics department

  PRINCIPAL INVESTIGATOR

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: December 17, 2023
• First Posted: January 2, 2024
• Study Start: December 6, 2022
• Primary Completion: July 10, 2023
• Study Completion: November 20, 2023
• Last Updated: February 28, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)