Marginal Bone Loss Around Mandibular Implant-retaining Overdentures and Implant Supported Fixed Hybrid Prosthesis

NCT06488599 | Enrolling By Invitation

• 1 other identifier: USJ-2023-20
• Study Type: observational
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Bone Loss in Jaw; Dental Implant Failure Nos; Dental Implant Failed

Outcome Measures

Primary Outcomes (1)

• Marginal Bone Loss in mm (MBL)

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

  5 years

Secondary Outcomes (8)

• smoking status

  5 years

• compliance and attendance to recall sessions

  5 years

• keratinized tissue hight

  5 years

• framework design

  5 years

• age

  5 years

Study Arms (2)

1- hybrid prosthesis

Patients having fixed hybrid prosthesis over 4 implants in the mandible for 5 years

Radiation: Peri-apical radiographs on the implants

2- over denture

Patients having removable overdenture with locators over 2 implants in the mandible for 5 years

Radiation: Peri-apical radiographs on the implants

Interventions

Peri-apical radiographs on the implants RADIATION

Peri-apical radiographs on the implants supporting the prosthesis

1- hybrid prosthesis; 2- over denture

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

To determine the sample size, a power analysis was conducted for independent Student t test using G\*Power and considering a power = 80%, alpha = 5%, and an effect size = 1.06. The minimum sample size required for this study is 50 implants in total: (25 per group)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Saint-Joseph University: lead

Study Sites (1)

Saint Joseph University of beirut

Beirut, 00000, Lebanon

Location

Study Officials

• Elies El Hachem, DDS

  Saint Joseph University of Beirut, Faculty of dental Medicine, Periodontolgy department

  PRINCIPAL INVESTIGATOR

• Nadim Mokbel, PhD

  Saint Joseph University of Beirut, Faculty of dental Medicine, Periodontolgy department

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2024
• First Posted: July 5, 2024
• Study Start: December 15, 2023
• Primary Completion: May 30, 2024
• Study Completion: July 20, 2024
• Last Updated: July 5, 2024

Record last verified: 2024-06

Locations

LE (1)