Prosthesis DurabilityNCT06958055
Vallecular Bolus Aggregation During Swallowing for Implant Overdenture.
A study testing videofluroscopy evaluation of swallowing function in people with Prosthesis Durability, run by Mansoura University at 1 site in Egypt.
Trial summary
evaluate the effect of implant retained mandibular overdenture on vallecular bolus aggregation during chewing and subsequent swallowing of solid food consistency. Read more about this study
- Who is it for?
- Ages 60 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Prosthesis Durability
- What is being tested?
- videofluroscopy evaluation of swallowing function
- 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
- 16 participants
- Where
- 1 siteEgypt
- Study dates
- 26 Jan 2024to 27 Mar 2025
- 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 60 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age >60 year.
- Class I maxilla-mandibular relation;
- Available inter-arch space.
- adequate bone quality and quality in the mandibular anterior alveolar ridge (inter-foraminal area).
Who cannot join
- Subjects with physical or cognitive limitations,
- Neurodegenerative disorders that could influence their swallowing function,
- Parafunctional habits,
- Smokers,
- Signs or symptoms of temporomandibular disorders,
- Osteoporosis,
- Uncontrolled systemic diseases,
- Previously undergone radiotherapy or laryngeal surgery
Trial locations and contacts
1 site in 1 country.
Egypt1 site
faculty of dentistry, mansoura university Mansoura, Egypt,
Al Mansurah, 35516
About this study
Official title: Vallecular Bolus Aggregation During Swallowing of Solid Food Boluses for Subject Rehabilitated With Mandibular Implant Retained Overdentures. A Crossover Study
evaluate the effect of implant retained mandibular overdenture on vallecular bolus aggregation during chewing and subsequent swallowing of solid food consistency.
Read the detailed description
Healthy edentulous subjects seeking prosthetic treatment at the prosthodontics department, Faculty of Dentistry, Mansoura University will be eligible for this study. The inclusion criteria will be: age >60 year; Class I maxilla-mandibular relation; available inter-arch space; and adequate bone quality and quality in the mandibular anterior alveolar ridge (inter-foraminal area). Subjects with physical or cognitive limitations, neurodegenerative disorders that could influence their swallowing function, parafunctional habits, smokers, signs or symptoms of temporomandibular disorders, osteoporosis, uncontrolled systemic diseases, previously undergone radiotherapy or laryngeal surgery will be excluded from the study.
Sample size estimation is based on a previous study evaluated the oral and pharyngeal phases of swallowing by videofluroscopy and found significant differences between groups. We determined that 16 participants will be required for the detection of significant differences with effect size of 0.78, 90% power, and 5% error probability. Ethical agreement will be taken from ethical committee of the faculty of dentistry and written consent will be gotten from all the participants after illustrating in detail the whole research protocol.
Prosthetic and surgical procedures:
For each patient, new conventional complete denture will be constructed with optimal denture extension and lingualized balanced occlusal scheme. The new prosthesis will be inserted intraorally and adjusted for occlusal interferences. Subsequently, two dental implants will be placed in the canines region according to guided surgery protocol and two-stage approach. After osseointegration, locator attachments will be screwed to the dental implants to convert the conventional mandibular denture to mandibular implant retained overdenture. The mandibular implant overdentutre will be inserted and occlusal adjustment will be done and follow up visits will be scheduled.
II- Evaluation method:
Each patient will be subjected to videofluoroscopic imaging at 3 different oral conditions; without denture, after 3 months of complete dentures insertion, and after 3 months of mandibular implant overdenture insertion.
Videofluroscopic (VF) assessment:
All participants will be evaluated by using videofluoroscopic evaluation of bolus movement. Each patient will be asked to chew ¼ of cookie (coated with pudding and barium powder) and swallow the bolus once they will be ready. The videofluoroscopic recordings will be transferred to the computer for later data analysis. EO program (Version 1.36) was used to analyze the videofluoroscopic recordings by placing numbers (1/100 second) on the video frame for later frame-by-frame data analysis.
The following parameters will be measured:
- Bolus location at swallow onset (BLSO).
- Swallow reaction time (SRT), that is, the interval, from bolus passing the mandible (BPM) to hyoid burst (HYB) onset.
- Vallecular aggregation time (VAT), that is, the interval, from BPM to end of aggregation (EOA), with EOA defined as the first frame showing the leading edge of the bolus moving below the level of the pit of the vallecular space.
- The EOA-to-HYB interval.
- Conditions
- Prosthesis Durability
- Being tested
- videofluroscopy evaluation of swallowing function
- Keywords
- vallecular aggregation, swallowing, solid food, implant overdenture
- Medical subject headings
- Prosthesis Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
videofluroscopy evaluation of swallowing functionRadiation
Videofluoroscopy swallowing evaluation was done using solid food bolus at three different oral conditions: Without dentures (WOD), with the conventional complete denture (CDs) and with mandibular implant retained overdenture (IODs).
| Study group | Role | What they receive |
|---|---|---|
| group I : complete edentulous patients | Placebo comparator | videofluroscopy for completely edentulous patients Receives: Radiation: videofluroscopy evaluation of swallowing function |
| group II: Conventional complete denture | Active comparator | complete denture construction for edentulous patient and videofluroscopy evaluation Receives: Radiation: videofluroscopy evaluation of swallowing function |
| group III: Implant overdentutres | Active comparator | construction of implant overdenture and videofluroscopy evaluation Receives: Radiation: videofluroscopy evaluation of swallowing function |
What is being measured
The primary outcome is the main question the study is designed to answer.
swallowing evaluation
videofluroscopy evaluation for swallowing function
Measured: after 3 months of denture and overdenture insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2025
- Study start26 Jan 2024
- Primary completion26 Oct 2024
- Study completion27 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prosthesis DurabilityStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- 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
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- abdallah M Ibrahim, PhD, Principal investigator, Mansoura university, Faculty of dentistry, prosthodontics department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06958055
- Sponsor's protocol ID
- A0102025RP
- Status last verified
- Apr 2025
- First submitted
- 27 Apr 2025
- Last updated
- 6 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vallecular Bolus Aggregation During Swallowing of Solid Food Boluses for Subject Rehabilitated With Mandibular Implant Retained Overdentures. A Crossover Study
- ClinicalTrials.gov ID
- NCT06958055
- Acronym / sponsor ID
- A0102025RP
- Conditions
- Prosthesis Durability
- Keywords
- vallecular aggregation, swallowing, solid food, implant overdenture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 26 Jan 2024 (actual)
- Primary completion
- 26 Oct 2024 (actual)
- Study completion
- 27 Mar 2025 (actual)
- First posted
- 6 May 2025 (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.
evaluate the effect of implant retained mandibular overdenture on vallecular bolus aggregation during chewing and subsequent swallowing of solid food consistency.
Detailed description
Healthy edentulous subjects seeking prosthetic treatment at the prosthodontics department, Faculty of Dentistry, Mansoura University will be eligible for this study. The inclusion criteria will be: age >60 year; Class I maxilla-mandibular relation; available inter-arch space; and adequate bone quality and quality in the mandibular anterior alveolar ridge (inter-foraminal area). Subjects with physical or cognitive limitations, neurodegenerative disorders that could influence their swallowing function, parafunctional habits, smokers, signs or symptoms of temporomandibular disorders, osteoporosis, uncontrolled systemic diseases, previously undergone radiotherapy or laryngeal surgery will be excluded from the study.
Sample size estimation is based on a previous study evaluated the oral and pharyngeal phases of swallowing by videofluroscopy and found significant differences between groups. We determined that 16 participants will be required for the detection of significant differences with effect size of 0.78, 90% power, and 5% error probability. Ethical agreement will be taken from ethical committee of the faculty of dentistry and written consent will be gotten from all the participants after illustrating in detail the whole research protocol.
Prosthetic and surgical procedures:
For each patient, new conventional complete denture will be constructed with optimal denture extension and lingualized balanced occlusal scheme. The new prosthesis will be inserted intraorally and adjusted for occlusal interferences. Subsequently, two dental implants will be placed in the canines region according to guided surgery protocol and two-stage approach. After osseointegration, locator attachments will be screwed to the dental implants to convert the conventional mandibular denture to mandibular implant retained overdenture. The mandibular implant overdentutre will be inserted and occlusal adjustment will be done and follow up visits will be scheduled.
II- Evaluation method:
Each patient will be subjected to videofluoroscopic imaging at 3 different oral conditions; without denture, after 3 months of complete dentures insertion, and after 3 months of mandibular implant overdenture insertion.
Videofluroscopic (VF) assessment:
All participants will be evaluated by using videofluoroscopic evaluation of bolus movement. Each patient will be asked to chew ¼ of cookie (coated with pudding and barium powder) and swallow the bolus once they will be ready. The videofluoroscopic recordings will be transferred to the computer for later data analysis. EO program (Version 1.36) was used to analyze the videofluoroscopic recordings by placing numbers (1/100 second) on the video frame for later frame-by-frame data analysis.
The following parameters will be measured:
- Bolus location at swallow onset (BLSO).
- Swallow reaction time (SRT), that is, the interval, from bolus passing the mandible (BPM) to hyoid burst (HYB) onset.
- Vallecular aggregation time (VAT), that is, the interval, from BPM to end of aggregation (EOA), with EOA defined as the first frame showing the leading edge of the bolus moving below the level of the pit of the vallecular space.
- The EOA-to-HYB interval.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| group I : complete edentulous patients | Placebo comparator | Radiation: videofluroscopy evaluation of swallowing functionvideofluroscopy for completely edentulous patients |
| group II: Conventional complete denture | Active comparator | Radiation: videofluroscopy evaluation of swallowing functioncomplete denture construction for edentulous patient and videofluroscopy evaluation |
| group III: Implant overdentutres | Active comparator | Radiation: videofluroscopy evaluation of swallowing functionconstruction of implant overdenture and videofluroscopy evaluation |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age >60 year.
- Class I maxilla-mandibular relation;
- Available inter-arch space.
- adequate bone quality and quality in the mandibular anterior alveolar ridge (inter-foraminal area).
Key exclusion criteria (8 listed)
- Subjects with physical or cognitive limitations,
- Neurodegenerative disorders that could influence their swallowing function,
- Parafunctional habits,
- Smokers,
- Signs or symptoms of temporomandibular disorders,
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 |
|---|---|---|
| videofluroscopy evaluation of swallowing functionVideofluoroscopy swallowing evaluation was done using solid food bolus at three different oral conditions: Without dentures (WOD), with the conventional complete denture (CDs) and with mandibular implant retained overdenture (IODs). | Radiation | group I : complete edentulous patients, group II: Conventional complete denture, group III: Implant overdentutres |
Primary outcome
swallowing evaluation
Time frame: after 3 months of denture and overdenture insertion
videofluroscopy evaluation for swallowing function
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 6 May 2025.
- Results publication: 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 M 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 videofluroscopy evaluation of swallowing function 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 4 inclusion and 8 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 6 May 2025. 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 and 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 NCT06958055, which also lists 1 linked publication.
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 6 May 2025.