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Prosthesis DurabilityNCT06187181

Hyoid Displacement During Swallowing Function for Completely Edentulous Subjects

A study testing implant overdenture and videofluroscopy in people with Prosthesis Durability, run by Mansoura University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 50 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Prosthesis Durability
What is being tested?
implant overdenture and videofluroscopy
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
25 participants
Where
1 siteEgypt
Study dates
6 Dec 2022to 20 Nov 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Faculty of Dentistry, Mansoura University

    Al Mansurah, 35516

Other trials in Egypt

About this study

Official title: Hyoid Displacement During Swallowing Function for Completely Edentulous Subjects Rehabilitated With Mandibular Implant Retained Overdenture

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

Read the detailed description

New conventional complete denture with optimal flange extension and well established lingualized balanced occlusal scheme was constructed for every patient. To construct the radiographic stent, clear acrylic resin duplicate for the mandibular denture was constructed, several small holes were made on the polished surface of the duplicate. These holes were filled with radio-opaque gutta-percha points to act as a reference points during determination of the quantity of available bone for implant placement and for construction of stereolithographic surgical guide.

Cone beam computerized tomography [i-CAT] was used to construct the stereolithographic surgical guide by applying dual scan technique. By using the surgical guide, two dental implants (Dentium implants, 12-14mm in length, 3.6-4mm in diameter, Superline II) were placed in the canine regions of the mandibular arch with guided surgical protocol. The patients were instructed to take prophylactic antibiotic two times a day (875mg Amoxicillin and 125mg Clavulanic acid) 24 hours before the surgery and continue after the surgery for seven days. Non-steroidal anti-inflammatory drug was used to control the pain.

After surgery, the complete denture was withdrawn, and the patient was instructed to eat soft diet. After one week, the mandibular denture was relieved and relined with Cold- curing silicon based relining material (Softliner, PROMEDICA). The dentures were delivered to the patients and follow up visits were scheduled. After three to four months, the dental implants were exposed, and the healing abutments were secured to the dental implants. After healing of the soft tissue (7-10 days), the healing abutments were removed, and ball attachments (Dentium ball abutment, Superline II) were screwed to the dental implants. Direct pick-up technique was used to incorporate the housing of the attachments into the fitting surface of the mandibular denture using self-cured acrylic resin material. The occlusion of the overdenture was evaluated to eliminate any premature occlusal contact then the overdenture was delivered to the patient.

Videofluroscopic swallowing study (VFSS):

All subjects were examined by using videofluroscopic swallowing study to evaluate bolus movements. This evaluation was done at three different oral conditions, without complete denture (WCD), after 2 months of conventional complete dentures insertion (CDs), and after 2 months of implant overdenture insertion (IODs). Each patient was instructed to swallow 10 ml of thin liquid {20% barium sulfate (Prontobario H.D®) and 80% water} three times. The records of the videofluroscopic swallowing evaluation were saved to the computer for later analysis. A software Program (EO Program) was used to placing timing on the frame of the video (1/100 second) and analyze the recording by frame by frame data analysis.

a- Spatial measurements: Superior hyoid displacement (vertical movement) and anterior hyoid displacement (horizontal movement) were measured according to dynamic swallowing study performed by Rebecca Leonard \& Katherine Kendall during pseudo rest position and during maximum overall hyoid displacement .24 Aline was drawn from anterior superior point of cervical spine 4 (p1) contacting anterior inferior point of cervical spine 2 (p2) and extended superiorly as necessary, then another line was extended from the anterior, inferior portion of the hyoid bone to meet the P1-P2 line at 90-degree intersection. The Measurement from the P1 to the intersection point (Hsup-rest) and from hyoid bone to the intersection point (Hant-rest) were recorded then the video was advanced until the hyoid bone showed maximum overall displacement and the previous procedure was repeated. The measurements from P1 to the intersection point (Hsup-max) and from the hyoid bone to the intersection point (Hant- max) were recoded. The difference between the maximum hyoid position (Hsup-max) and the pseudo rest position (Hsup-rest) in the vertical direction was called the superior hyoid displacement, while the difference between maximum hyoid position (Hant-max) and pseudo rest position (Hant-rest) in the horizontal direction was called anterior hyoid displacements.

B- Temporal measurements:

  1. Duration of hyoid maximum elevation (DOHME): Measured from the first frame showing maximum hyoid elevation to last frame showing maximum hyoid elevation.
  2. Duration of hyoid maximum anterior excursion (DOHMAE):

Measured from the first frame showing maximum anterior hyoid movement to last frame showing maximum anterior hyoid movement.

C- Penetration / aspiration scale:

Penetration was defined as the food bolus enter the airway down to the vocal folds, while aspiration defined as the food bolus enter the airway below the level of the vocal folds.

0= No penetration or aspiration

  1. Penetration
  2. Aspiration
Being tested
implant overdenture, videofluroscopy
Keywords
Hyoid bone., implant., overdenture, swallowing.
Medical subject headings
Prosthesis Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • implant overdentureProcedure or surgery

    . 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).

  • videofluroscopyRadiation

    videofluroscopy evaluation of swallowing function

Study groups in NCT06187181
Study groupRoleWhat they receive
G. I : Completely edentulous patientsPlacebo comparatorvideofluroscopy for completely edentulous patients
Receives: Radiation: videofluroscopy
G.II: patients with complete denturesActive comparatorcomplete denture construction for edentulous patient and videofluroscopy evaluation
Receives: Procedure: implant overdenture; Radiation: videofluroscopy
G.III: patients with implant overdenturesActive comparatorconstruction of implant overdenture and videofluroscopy evaluation
Receives: Procedure: implant overdenture; Radiation: videofluroscopy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. swallowing evaluation

    hyoid bone displacement evaluation by videofluriscopy

    Measured: after 3 months of denture or overdenture insertion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jan 2024
  2. Study start6 Dec 2022
  3. Primary completion10 Jul 2023
  4. Study completion20 Nov 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Participant
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06187181
Sponsor's protocol ID
A19061222
Status last verified
Dec 2023
First submitted
17 Dec 2023
Last updated
28 Feb 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 25664612
  • 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.

    PubMed 39118020

Questions about this trial

What is this clinical trial studying?

A study testing implant overdenture and videofluroscopy in people with Prosthesis Durability, run by Mansoura University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

swallowing evaluation (time frame: after 3 months of denture or overdenture insertion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06187181, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.

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