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Clinical Trials/NCT06488599
NCT06488599
Enrolling by Invitation
N/A

Marginal Bone Loss Around Mandibular Implant-retaining Overdentures and Implant Supported Fixed Hybrid Prosthesis: A 5-year Follow-up

Saint-Joseph University1 site in 1 country19 target enrollmentDecember 15, 2023

Overview

Phase
N/A
Intervention
Not specified
Conditions
Bone Loss in Jaw
Sponsor
Saint-Joseph University
Enrollment
19
Locations
1
Primary Endpoint
Marginal Bone Loss in mm (MBL)
Status
Enrolling by Invitation
Last Updated
last year

Overview

Brief Summary

Few if any studies have compared marginal bone loss (MBL) around implant-retaining overdentures (2 implants with locators) versus implant supported fixed hybrid prosthesis (over 4 implants) in the mandible.

Detailed Description

Material and Methods: Patients of the saint Joseph university dental clinics, who have already in their records peri-apical radiographs of the implants post loading, will be divided in 2 groups depending on the prosthetic treatment that they have had for 5 years in mouth, and will be recalled for a check-up session during which the investigators will take new peri-apical X-rays by means of the parallel long-cone technique for the implants that are supporting/retaining the prosthesis. A total of minimum 50 implants placed in a minimum of 19 patients will be examined. The mean mesial and distal radiographic MBL and bone to implant contact (BIC) will be recorded by comparing the two X-rays for each implant. the investigators will also investigate the possibly related factors that may have contributed to this marginal bone loss such as the medical history, smoking habits, oral hygiene, compliance, presence of keratinized tissue and possibility of proper cleaning. Results: the investigators aim to find a statistically significant difference in the Marginal bone loss around implants assisting these two types of prosthesis and a possible correlation with some risk and modifying factors.

Registry
clinicaltrials.gov
Start Date
December 15, 2023
End Date
July 20, 2024
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Saint-Joseph University
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patients treated with mandibular implant-retaining overdentures (2 implants)
  • Patients treated with mandibular implant-supported fixed hybrid prosthesis (4 implants)
  • Patients having in their records a post-loading peri-apical radiograph for the implants
  • Patients who have had their prosthesis for 5 years in mouth

Exclusion Criteria

  • Patients treated with mandibular implant-retaining overdentures with more or less than 2 implants
  • Patients treated with mandibular implant-supported fixed hybrid prosthesis with more or less than 4 implants Patients treated with any other prosthetic option on implants Patients who don't have a post-loading peri-apical radiograph in their records

Outcomes

Primary Outcomes

Marginal Bone Loss in mm (MBL)

Time Frame: 5 years

MBL in mm around implants in patients having a removable prosthesis over locators and in patients having a screw retained hybrid prosthesis

Secondary Outcomes

  • sex(5 years)
  • age(5 years)
  • framework design(5 years)
  • compliance and attendance to recall sessions(5 years)
  • keratinized tissue hight(5 years)
  • health status(5 years)
  • plaque score(5 years)
  • smoking status(5 years)

Study Sites (1)

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