NCT06795295

Brief 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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2023

Geographic Reach
1 country

1 active site

Status
completed

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

September 18, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 18, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 20, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 28, 2025

Completed
Last Updated

January 28, 2025

Status Verified

January 1, 2025

Enrollment Period

1 year

First QC Date

January 20, 2025

Last Update Submit

January 25, 2025

Conditions

Swallowing

Keywords

swallowing dynamic

Outcome Measures

Primary Outcomes (2)

  • 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)

    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

    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.

Study Arms (2)

Group І 2- IMOVD

ACTIVE COMPARATOR

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

Procedure: Implant retained mandibular overdenture

Group ІІ 1-IMOVD

ACTIVE COMPARATOR

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

Procedure: Implant retained mandibular overdenture

Interventions

Implant retained mandibular overdenturePROCEDURE

Participants received dental implants to retain mandibular overdentures.

Also known as: BTK implant
Group І 2- IMOVDGroup ІІ 1-IMOVD

Eligibility Criteria

Age45 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry, Mansoura Universty

Al Mansurah, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical demonstrator, Prosthodontic Department, Faculty of dentistry, Mansoura University

Study Record Dates

First Submitted

January 20, 2025

First Posted

January 28, 2025

Study Start

September 18, 2023

Primary Completion

September 18, 2024

Study Completion

December 20, 2024

Last Updated

January 28, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)