Swallowing Dynamic of Implant Retained Mandibular Overdentures

January 25, 2025 updated by: Mohamed Taha Abdo El_Baz, Mansoura University

Swallowing Dynamic of Two Implant Versus Single Implant Retained Mandibular Overdentures

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Mansoura, Egypt
        • Faculty of Dentistry, Mansoura Universty

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Participants received dental implants to retain mandibular overdentures.
Other Names:
  • BTK implant
Active Comparator: Group ІІ 1-IMOVD
Patients received single mandibular midline implant to retain mandibular overdenture with locator attachment
Procedure: Implant retained mandibular overdenture
Participants received dental implants to retain mandibular overdentures.
Other Names:
  • BTK implant

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Swallowing Dynamic Of Two Implant Versus Single Implant Retained Mandibular Overdentures
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.
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)
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.
Swallowing Dynamic Of Two Implant Versus Single Implant Retained Mandibular Overdentures
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.
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)
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 18, 2023

Primary Completion (Actual)

September 18, 2024

Study Completion (Actual)

December 20, 2024

Study Registration Dates

First Submitted

January 20, 2025

First Submitted That Met QC Criteria

January 25, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 25, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • A05011122

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

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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