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RecruitingNCT06206005Updated Jan 26, 2024

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

An observational study in Bone Resorption, sponsored by Mansoura University. Recruiting at 1 site in Egypt. Open to participants aged 55 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-01-26.

Sponsored by Mansoura University · Observational

From the registry’s dates

  • Primary completion was expected by May 2024, 2 years 6 months ago, but the record still lists the study as recruiting.
  • Started Dec 2023; still recruiting 2 years 11 months later.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
20
Ages
55 Years to 65 Years
Sex
All
01

Study summary

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

Read the detailed 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.

02

Conditions studied

  • Bone Resorption

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03

In context

Bone Resorption

167 studies on the registry are indexed under Bone Resorption; 28 are open to participants now.

This study's planned enrollment of 20 is below the median of 43 across 18 observational studies indexed under Bone Resorption.

Browse Bone Resorption studies →

Lead sponsor

Mansoura University is the lead sponsor of 1,119 studies on the registry; 183 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
55 Years to 65 Years
Sexes eligible
All
Sampling method
Probability sample

Study population

20 participants at least.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 , 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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
20 participants (estimated)
Patient registry
No

Groups and cohorts

  • Group1 with Haemoglobin A1c ≤6.5%

    This group represents a well-controlled type 2 Diabetics mellitus.

    Other: Observational study

  • Group 2 with Haemoglobin A1c >6.5%

    This group represents a poorly controlled type 2 Diabetics mellitus.

    Other: Observational study

Interventions

  • OtherObservational study

    evaluate implant survival, peri-implant outcome of 4 implant retained mandibular OVD after 10 years of function.

06

What researchers measure

Primary outcomes

  1. Crestal bone loss around implants

    amount of bone loss which appears on a periapical radiograph

    Time frame: This is a retrospective study, Measurement will be performed after implants being in service by 10 years

Secondary outcomes

  1. Probing depth

    By using a plastic periodontal probe to measure the probing depth around the implants

    Time frame: This is a retrospective study, Measurement will be performed after implants being in service by 10 years

07

Study locations

1 of 1 sites recruiting
  • Mohammed ELSawy
    Mansoura, 12345, Egypt
    Recruiting
08

References and documents

Individual participant data

Plan to share: No — The IPD is upon request from the corresponding author

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 26, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06206005
Collaborators
Menoufia University
Responsible party
Mohamed Elsawy (lecturer, Department of prosthodontics, principle investigator, Mansoura University) — Principal investigator
First posted
Jan 16, 2024
Start date
Dec 4, 2023
Primary completion
May 5, 2024 (estimated)
Completion
Aug 5, 2024 (estimated)
Last update
Jan 26, 2024

Study contacts

Mohammed Elsawy, PhD
Contact
Dr_sawy@windowslive.com
00201061314522
Doaa A. mewafy, PhD
Contact
Doaamowafy@mans.edu.eg
00201061133971

Oversight

FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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