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

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Dental Implant Failed; Dental Implant Failure Nos; Bone Loss in Jaw
• Intervention / Treatment: Radiation: Peri-apical radiographs on the implants

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.

• Study Type: Observational
• Enrollment (Estimated): 19

Contacts and Locations

Study Locations

• Lebanon
  • Beirut, Lebanon, 00000
    • Saint Joseph University of Beirut

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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)

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
1- hybrid prosthesis; Patients having fixed hybrid prosthesis over 4 implants in the mandible for 5 years	Radiation: Peri-apical radiographs on the implants; Peri-apical radiographs on the implants supporting the prosthesis
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; Peri-apical radiographs on the implants supporting the prosthesis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
smoking status	non smoker, smoker less than 10 cig/day, smoker more than 10 cig/day	5 years
compliance and attendance to recall sessions	patient attending the recall sessions or no	5 years
keratinized tissue hight	measured in mm with a periodontal probe	5 years
framework design	prosthetic framework fit/misfit	5 years
age	in years	5 years
health status	diabetes yes/no ; cardiovascular disease yes/no	5 years
sex	male female	5 years
plaque score	using the modified plaque index (0 absence,1 detectable by a probe, 2 visible, 3 abundant)	5 years

Collaborators and Investigators

• Sponsor: Saint-Joseph University
• Investigators: Principal Investigator: Elies El Hachem, DDS, Saint Joseph University of Beirut, Faculty of dental Medicine, Periodontolgy department; Study Director: Nadim Mokbel, PhD, Saint Joseph University of Beirut, Faculty of dental Medicine, Periodontolgy department

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2023
• Primary Completion (Actual): May 30, 2024
• Study Completion (Estimated): July 20, 2024

Study Registration Dates

• First Submitted: June 24, 2024
• First Submitted That Met QC Criteria: July 3, 2024
• First Posted (Actual): July 5, 2024

Study Record Updates

• Last Update Posted (Actual): July 5, 2024
• Last Update Submitted That Met QC Criteria: July 3, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic
• Other Study ID Numbers: USJ-2023-20

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No