Four Mandibular Implant-retained Overdentures in Individuals With Type 2 Diabetes

M

Mansoura University

Status

Enrolling

Conditions

Bone Resorption

Treatments

Other: Observational study

Study type

Observational

Funder types

Other

Identifiers

NCT06206005
A03012023RP

Details and patient eligibility

About

Studies clinically evaluate the long-term outcome of 4 implant attachment-retained mandibular OVDs among patients with high glycemic levels are lacking.

Full description

Chronic hyperglycemia is considered as a typical risk-factor that causes soft tissue inflammation and bone loss around natural teeth and implants. One possible explanation for this mechanism is that chronic hyperglycemia has the propensity to increase the levels of accumulated glycation end products (AGEs) in the serum and oral tissues that accelerates the production of proinflammatory cytokines that induce bone destruction around natural teeth and implants. However, it is relevant to indicate that dental implants in chronic hyperglycemia under ideal glycemic conditions can successfully osseointegrate and show predictable outcomes over long durations in both diabetic and non-diabetic patients. Studies clinically evaluate the long-term outcome of 4 implant attachment-retained mandibular OVDs among patients with high glycemic levels are lacking.

Enrollment

20 estimated patients

Sex

All

Ages

55 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients with edentulous maxilla and mandible for at least 12 months.
  • Patients have problems with mandibular denture retention and stability.
  • Patients with a mandibular bone height measured on a panoramic x-ray between 15 and 25 mm at the mandibular symphysis region.

Exclusion criteria

  • Patients who did not receive implants at the department clinic.
  • Patients with more or less than 4 implants in the mandible.
  • Patients with well controlled diabetics.
  • Patients with relative contraindications, such as a history of parafunctional habits, daily smokers of more than 10 cigarettes, or alcoholism.
  • Patients who have previously received head and neck radiation therapy; furthermore, patients receiving intravenous bisphosphonates, chemotherapy, or psychological disorders could jeopardize their cooperation.

Trial design

20 participants in 2 patient groups

Group1 with Haemoglobin A1c ≤6.5%
Description:
This group represents a well-controlled type 2 Diabetics mellitus.
Treatment:
Other: Observational study
Group 2 with Haemoglobin A1c >6.5%
Description:
This group represents a poorly controlled type 2 Diabetics mellitus.
Treatment:
Other: Observational study

Trial contacts and locations

1

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Central trial contact

Doaa A. mewafy, PhD; Mohammed Elsawy, PhD

Data sourced from clinicaltrials.gov

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