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Swallowing Dynamic of Implant Retained Mandibular Overdentures

M

Mansoura University

Status

Completed

Conditions

Swallowing

Treatments

Procedure: Implant retained mandibular overdenture

Study type

Interventional

Funder types

Other

Identifiers

NCT06795295
A05011122

Details and patient eligibility

About

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)

Full 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.

Enrollment

8 patients

Sex

All

Ages

45 to 70 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

8 participants in 2 patient groups

Group І 2- IMOVD
Active Comparator group
Description:
Patients received two implant on the mandibular canine regions to retain mandibular overdenture with locator attachment
Treatment:
Procedure: Implant retained mandibular overdenture
Group ІІ 1-IMOVD
Active Comparator group
Description:
Patients received single mandibular midline implant to retain mandibular overdenture with locator attachment
Treatment:
Procedure: Implant retained mandibular overdenture

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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