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

NCT06206005 | Unknown

• 1 other identifier: A03012023RP
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Bone Resorption

Outcome Measures

Primary Outcomes (1)

• Crestal bone loss around implants

  amount of bone loss which appears on a periapical radiograph

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

Secondary Outcomes (1)

• Probing depth

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

Study Arms (2)

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

Observational study OTHER

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

Group 2 with Haemoglobin A1c >6.5%; Group1 with Haemoglobin A1c ≤6.5%

Eligibility Criteria

• Age: 55 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

20 participants at least.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mansoura University: lead
• Menoufia University: collaborator

Study Sites (1)

Mohammed ELSawy

Al Mansurah, 12345, Egypt

RECRUITING

MeSH Terms

Conditions

Bone Resorption

Interventions

Observation

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Central Study Contacts

Mohammed Elsawy, PhD

CONTACT

00201061314522; Dr_sawy@windowslive.com

Doaa A. mewafy, PhD

CONTACT

00201061133971; Doaamowafy@mans.edu.eg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer, Department of prosthodontics, principle investigator

Study Record Dates

• First Submitted: January 4, 2024
• First Posted: January 16, 2024
• Study Start: December 4, 2023
• Primary Completion: May 5, 2024
• Study Completion: August 5, 2024
• Last Updated: January 26, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)