Clinical trial NCT06488599: Marginal Bone Loss Around Mandibular Implant-retaining Overdentures and Implant Supported Fixed Hybrid Prosthesis
Official title: Marginal Bone Loss Around Mandibular Implant-retaining Overdentures and Implant Supported Fixed Hybrid Prosthesis: A 5-year Follow-up
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Bone Loss in Jaw
Dental Implant Failure Nos
Dental Implant Failed
Lead sponsor: Saint-Joseph University
Sponsor class: OTHER
First posted: 2024-07-05
Enrollment: 19
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
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)

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.

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

Primary outcomes:
measure: Marginal Bone Loss in mm (MBL)
timeFrame: 5 years
Secondary outcomes:
measure: smoking status
timeFrame: 5 years
measure: compliance and attendance to recall sessions
timeFrame: 5 years
measure: keratinized tissue hight
timeFrame: 5 years
measure: framework design
timeFrame: 5 years
measure: age
timeFrame: 5 years
measure: health status
timeFrame: 5 years
measure: sex
timeFrame: 5 years
measure: plaque score
timeFrame: 5 years
Other outcomes:
Locations:
city: Beirut
country: Lebanon
facility: Saint Joseph University of beirut
Study officials:
affiliation: Saint Joseph University of Beirut, Faculty of dental Medicine, Periodontolgy department
name: Elies El Hachem, DDS
role: PRINCIPAL_INVESTIGATOR
affiliation: Saint Joseph University of Beirut, Faculty of dental Medicine, Periodontolgy department
name: Nadim Mokbel, PhD
role: STUDY_DIRECTOR
References: