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.
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
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- 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.
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:
- Duration of hyoid maximum elevation (DOHME): Measured from the first frame showing maximum hyoid elevation to last frame showing maximum hyoid elevation.
- 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
- Penetration
- Aspiration
- Conditions
- Prosthesis Durability
- 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 group | Role | What they receive |
|---|---|---|
| G. I : Completely edentulous patients | Placebo comparator | videofluroscopy for completely edentulous patients Receives: Radiation: videofluroscopy |
| G.II: patients with complete dentures | Active comparator | complete denture construction for edentulous patient and videofluroscopy evaluation Receives: Procedure: implant overdenture; Radiation: videofluroscopy |
| G.III: patients with implant overdentures | Active comparator | construction 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.
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.
- First posted2 Jan 2024
- Study start6 Dec 2022
- Primary completion10 Jul 2023
- Study completion20 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Prosthesis DurabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- abdallah Ibrahim, PhD, Principal investigator, Mansoura university, Faculty of dentistry, prosthodontics department
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 25664612Ibrahim 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
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyoid Displacement During Swallowing Function for Completely Edentulous Subjects Rehabilitated With Mandibular Implant Retained Overdenture
- ClinicalTrials.gov ID
- NCT06187181
- Acronym / sponsor ID
- A19061222
- Conditions
- Prosthesis Durability
- Keywords
- Hyoid bone., implant., overdenture, swallowing.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 6 Dec 2022 (actual)
- Primary completion
- 10 Jul 2023 (actual)
- Study completion
- 20 Nov 2023 (actual)
- First posted
- 2 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate the effect of wearing mandibular implant retained overdentures on superior and anterior hyoid displacement during swallowing process.
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:
- Duration of hyoid maximum elevation (DOHME): Measured from the first frame showing maximum hyoid elevation to last frame showing maximum hyoid elevation.
- 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
- Penetration
- Aspiration
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| G. I : Completely edentulous patients | Placebo comparator | Radiation: videofluroscopyvideofluroscopy for completely edentulous patients |
| G.II: patients with complete dentures | Active comparator | Procedure: implant overdenture, Radiation: videofluroscopycomplete denture construction for edentulous patient and videofluroscopy evaluation |
| G.III: patients with implant overdentures | Active comparator | Procedure: implant overdenture, Radiation: videofluroscopyconstruction of implant overdenture and videofluroscopy evaluation |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- participants with temporomandibular joint disorder,
- head and neck surgery,
- sleep apnea
- skeletal deformity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| implant overdenture. 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). | Procedure or surgery | G.II: patients with complete dentures, G.III: patients with implant overdentures |
| videofluroscopyvideofluroscopy evaluation of swallowing function | Radiation | G. I : Completely edentulous patients, G.II: patients with complete dentures, G.III: patients with implant overdentures |
Primary outcome
swallowing evaluation
Time frame: after 3 months of denture or overdenture insertion
hyoid bone displacement evaluation by videofluriscopy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Background: PubMed 25664612Kern 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.
- Derived from this study: PubMed 39118020Ibrahim 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
abdallah Ibrahim, PhD principal investigator
Mansoura university, Faculty of dentistry, prosthodontics department
1 site in 1 country: see every site and its status.
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.