An observational study in Bone Loss in Jaw, Dental Implant Failure Nos and Dental Implant Failed, sponsored by Saint-Joseph University. Enrolling by invitation at 1 site in Lebanon. Per ClinicalTrials.gov, last updated 2024-07-05.
Sponsored by Saint-Joseph University · Observational
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.
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.
470 studies on the registry are indexed under Bone Diseases, Metabolic; 71 are open to participants now.
This study's planned enrollment of 19 is below the median of 81 across 103 observational studies indexed under Bone Diseases, Metabolic.
Browse Bone Diseases, Metabolic studies →Saint-Joseph University is the lead sponsor of 71 studies on the registry; 11 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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)
Exclusion Criteria:
Patients having fixed hybrid prosthesis over 4 implants in the mandible for 5 years
Radiation: Peri-apical radiographs on the implants
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
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
Time frame: 5 years
smoking status
non smoker, smoker less than 10 cig/day, smoker more than 10 cig/day
Time frame: 5 years
compliance and attendance to recall sessions
patient attending the recall sessions or no
Time frame: 5 years
keratinized tissue hight
measured in mm with a periodontal probe
Time frame: 5 years
framework design
prosthetic framework fit/misfit
Time frame: 5 years
age
in years
Time frame: 5 years
health status
diabetes yes/no ; cardiovascular disease yes/no
Time frame: 5 years
sex
male female
Time frame: 5 years
plaque score
using the modified plaque index (0 absence,1 detectable by a probe, 2 visible, 3 abundant)
Time frame: 5 years
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Saint-Joseph University