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Completed

NCT Number: NCT06795295

Swallowing Dynamic of 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)

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Key information

Conditions

Age range

45 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Mansoura Universty

Al Mansurah, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Implant retained mandibular overdenture

Procedure

Participants received dental implants to retain mandibular overdentures.

Other names: BTK implant

Primary outcomes

  1. 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)

  2. 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)

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

Swallowing Dynamic of Two Implant Versus Single Implant Retained Mandibular Overdentures

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 28, 2025
Registry last updated
Jan 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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