Swallowing Dynamic of Implant Retained Mandibular Overdentures

NCT ID: NCT06795295

Last Updated: 2025-01-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-18

Study Completion Date

2024-12-20

Brief Summary

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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)

Detailed Description

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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.

Conditions

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Swallowing

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group І 2- IMOVD

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

Group Type ACTIVE_COMPARATOR

Implant retained mandibular overdenture

Intervention Type PROCEDURE

Participants received dental implants to retain mandibular overdentures.

Group ІІ 1-IMOVD

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

Group Type ACTIVE_COMPARATOR

Implant retained mandibular overdenture

Intervention Type PROCEDURE

Participants received dental implants to retain mandibular overdentures.

Interventions

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Implant retained mandibular overdenture

Participants received dental implants to retain mandibular overdentures.

Intervention Type PROCEDURE

Other Intervention Names

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BTK implant

Eligibility Criteria

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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.
Minimum Eligible Age

45 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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Mohamed Taha Abdo El_Baz

Clinical demonstrator, Prosthodontic Department, Faculty of dentistry, Mansoura University

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of Dentistry, Mansoura Universty

Al Mansurah, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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A05011122

Identifier Type: -

Identifier Source: org_study_id

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