Vallecular Bolus Aggregation During Swallowing for Implant Overdenture.
1 other identifier
interventional
16
1 country
1
Brief Summary
evaluate the effect of implant retained mandibular overdenture on vallecular bolus aggregation during chewing and subsequent swallowing of solid food consistency.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 26, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 26, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 27, 2025
CompletedFirst Submitted
Initial submission to the registry
April 27, 2025
CompletedFirst Posted
Study publicly available on registry
May 6, 2025
CompletedMay 6, 2025
April 1, 2025
9 months
April 27, 2025
April 27, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
swallowing evaluation
videofluroscopy evaluation for swallowing function
after 3 months of denture and overdenture insertion
Study Arms (3)
group I : complete edentulous patients
PLACEBO COMPARATORvideofluroscopy for completely edentulous patients
group II: Conventional complete denture
ACTIVE COMPARATORcomplete denture construction for edentulous patient and videofluroscopy evaluation
group III: Implant overdentutres
ACTIVE COMPARATORconstruction of implant overdenture and videofluroscopy evaluation
Interventions
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).
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
faculty of dentistry, mansoura university Mansoura, Egypt,
Al Mansurah, 35516, Egypt
Related Publications (1)
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: 39118020RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
abdallah M Ibrahim, PhD
Mansoura university, Faculty of dentistry, prosthodontics department
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
April 27, 2025
First Posted
May 6, 2025
Study Start
January 26, 2024
Primary Completion
October 26, 2024
Study Completion
March 27, 2025
Last Updated
May 6, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will not share