Vallecular Bolus Aggregation During Swallowing for Implant Overdenture.

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.

Study Overview

• Status: Completed
• Conditions: Prosthesis Durability
• Intervention / Treatment: Radiation: videofluroscopy evaluation of swallowing function

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 Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Mansoura, Egypt, 35516
    • faculty of dentistry, mansoura university Mansoura, Egypt,

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: group I : complete edentulous patients; videofluroscopy for completely edentulous patients	Radiation: videofluroscopy evaluation of swallowing function; 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).
Active Comparator: group II: Conventional complete denture; complete denture construction for edentulous patient and videofluroscopy evaluation	Radiation: videofluroscopy evaluation of swallowing function; 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).
Active Comparator: group III: Implant overdentutres; construction of implant overdenture and videofluroscopy evaluation	Radiation: videofluroscopy evaluation of swallowing function; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
swallowing evaluation	videofluroscopy evaluation for swallowing function	after 3 months of denture and overdenture insertion

Collaborators and Investigators

• Sponsor: Mansoura University
• Investigators: Principal Investigator: abdallah M Ibrahim, PhD, Mansoura university, Faculty of dentistry, prosthodontics department

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 26, 2024
• Primary Completion (Actual): October 26, 2024
• Study Completion (Actual): March 27, 2025

Study Registration Dates

• First Submitted: April 27, 2025
• First Submitted That Met QC Criteria: April 27, 2025
• First Posted (Actual): May 6, 2025

Study Record Updates

• Last Update Posted (Actual): May 6, 2025
• Last Update Submitted That Met QC Criteria: April 27, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: swallowing; solid food; implant overdenture; vallecular aggregation
• Additional Relevant MeSH Terms: Postoperative Complications; Pathologic Processes; Prosthesis Failure
• Other Study ID Numbers: A0102025RP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No