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CompletedNCT06795295Updated Jan 28, 2025

Swallowing Dynamic of Implant Retained Mandibular Overdentures

An interventional study of Implant retained mandibular overdenture in Swallowing, sponsored by Mansoura University. Completed at 1 site in Egypt. Open to participants aged 45 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-01-28.

Sponsored by Mansoura University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 4 months after the study started (first participant enrolled Sep 2023, registered Jan 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
8
Allocation
Randomized
Ages
45 Years to 70 Years
Sex
All
01

Study summary

This Randomized clinical study was conducted to compare between two-implant versus single implant-retained mandibular overdenture regarding swallowing dynamic using The Test of Mastication and Swallowing Solids (TOMASS) and the Timed Water Swallow Test (TWST)

Read the detailed description

There are lack of studies comparing single and two implant-retained mandibular overdentures regarding swallowing dynamic. This Randomized clinical study aimed to compare the effect of two treatment modalities of mandibular implant over denture on the swallowing dynamic.

8 completely edentulous patients were selected from the Out-Patient Clinic of Prosthodontics' Department, Faculty of Dentistry, Mansoura University seeking prosthetic rehabilitation. All patients were randomly distributed into two equal groups; Group I (Patients received two-implant mandibular overdenture with locator attachment) and Group II ( Patients received single implant mandibular overdenture with locator attachment) All subjects received a newly carefully constructed complete dentures and then the lower dentures were changed into mandibular implant retained overdentures using locator attachments by placing two implants on the mandibular canine regions for group I and single midline implant for group II.

Swallowing dynamic was evaluated after 3 months of complete denture insertion for both groups. After mandibular overdenture insertion swallowing dynamic was evaluated 2 weeks after insertion and three months after overdenture insertion for both groups.

02

Conditions studied

  • Swallowing

Keywords

  • swallowing dynamic
03

In context

Lead sponsor

Mansoura University is the lead sponsor of 1,077 studies on the registry; 182 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Free from any systemic disease.
  • Free from any medical or surgical conditions that cause dysphagia (swallowing problems).
  • A sufficient residual alveolar bone quantity (height and width). This was verified by a CT scan using cone-beam computed tomography for each patient.
  • All patients had sufficient bone either D2 or D3 by measuring the Hounsfield unit on CBCT scan.
  • Residual ridges are covered by firm healthy mucosa.
  • Class I maxilla-mandibular relationship.
  • sufficient inter-arch space and restorative space for locator retained mandibular overdenture.

Exclusion criteria

Exclusion Criteria:

  • Patient with absolute contraindications for implant placement such as active cancer, immunosuppression, bleeding issues, and metabolic diseases that directly affect the bone such as osteoporosis, and hyperparathyroidism.
  • Patients with relative contraindication: history of para functional habits such as bruxism, clenching, and bad habits such as smoking and alcoholism, uncontrolled diabetic patients.
  • Patients with local contraindications for implant placement due to localized bone defects.
  • Non-cooperative patients who don't follow instructions during and after the operation.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
8 participants (actual)

Study arms

  • Active comparator
    Group І 2- IMOVD

    Patients received two implant on the mandibular canine regions to retain mandibular overdenture with locator attachment

    Procedure: Implant retained mandibular overdenture

  • Active comparator
    Group ІІ 1-IMOVD

    Patients received single mandibular midline implant to retain mandibular overdenture with locator attachment

    Procedure: Implant retained mandibular overdenture

Interventions

  • ProcedureImplant retained mandibular overdenture

    Participants received dental implants to retain mandibular overdentures.

    Also known as: BTK implant

06

What researchers measure

Primary outcomes

  1. Swallowing Dynamic Of Two Implant Versus Single Implant Retained Mandibular Overdentures

    Evaluation of swallowing dynamic of both groups was done by The Test of Mastication and Swallowing Solids (TOMASS) to measure (number of swallows,number of chews,and total time)

    Time frame: The evaluation of swallowing by TOMASS for(no swallows, no of chews,and total time)was done after 3 months (3M-CD) of CD insertion, three months (3M-OD) after overdenture insertion.

  2. Swallowing Dynamic Of Two Implant Versus Single Implant Retained Mandibular Overdentures

    swallowing dynamic of both groups was evaluated by the Timed Water Swallow Test (TWST) to measure (time per swallow, volume per swallow,and swallowing capcity)

    Time frame: The evaluation of swallowing by TWST for (time per swallow, volume per swallow, and swallowing capcity) was done after 3 months (3M-CD) of CD insertion, three months (3M-OD) after overdenture insertion.

07

Study locations

1 site
  • Faculty of Dentistry, Mansoura Universty
    Mansoura, Egypt
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 28, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06795295
Lead sponsor
Mansoura University
Responsible party
Mohamed Taha Abdo El_Baz (Clinical demonstrator, Prosthodontic Department, Faculty of dentistry, Mansoura University, Mansoura University) — Principal investigator
First posted
Jan 28, 2025
Start date
Sep 18, 2023
Primary completion
Sep 18, 2024
Completion
Dec 20, 2024
Last update
Jan 28, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

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