Bone Loss in JawNCT06488599
Marginal Bone Loss Around Mandibular Implant-retaining Overdentures and Implant Supported Fixed Hybrid Prosthesis
An observational study of Bone Loss in Jaw and Dental Implant Failure Nos, run by Saint-Joseph University at 1 site in Lebanon.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Bone Loss in Jaw, Dental Implant Failure Nos, Dental Implant Failed
- What is being tested?
- Peri-apical radiographs on the implants
- Type of treatment
- Surgery or procedure
- How many people
- 19 participants
- Where
- 1 siteLebanon
- Study dates
- 15 Dec 2023to 20 Jul 2024
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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)
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Peri-apical radiographs on the implants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peri-apical radiographs on the implantsRadiation
Peri-apical radiographs on the implants supporting the prosthesis
| Study group | Role | What they receive |
|---|---|---|
| 1- hybrid prosthesis | Patients having fixed hybrid prosthesis over 4 implants in the mandible for 5 years Receives: 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 Receives: Radiation: Peri-apical radiographs on the implants |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 5 years
Secondary outcomes (8)
smoking status
non smoker, smoker less than 10 cig/day, smoker more than 10 cig/day
Measured: 5 years
compliance and attendance to recall sessions
patient attending the recall sessions or no
Measured: 5 years
keratinized tissue hight
measured in mm with a periodontal probe
Measured: 5 years
framework design
prosthetic framework fit/misfit
Measured: 5 years
age
in years
Measured: 5 years
health status
diabetes yes/no ; cardiovascular disease yes/no
Measured: 5 years
sex
male female
Measured: 5 years
plaque score
using the modified plaque index (0 absence,1 detectable by a probe, 2 visible, 3 abundant)
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2024
- Study start15 Dec 2023
- Primary completion30 May 2024
- Study completion20 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone Loss in JawStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 19 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Saint-Joseph University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elies El Hachem, DDS, Principal investigator, Saint Joseph University of Beirut, Faculty of dental Medicine, Periodontolgy departmentNadim Mokbel, PhD, Study director, Saint Joseph University of Beirut, Faculty of dental Medicine, Periodontolgy department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06488599
- Sponsor's protocol ID
- USJ-2023-20
- Status last verified
- Jun 2024
- First submitted
- 24 Jun 2024
- Last updated
- 5 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Marginal Bone Loss Around Mandibular Implant-retaining Overdentures and Implant Supported Fixed Hybrid Prosthesis: A 5-year Follow-up
- ClinicalTrials.gov ID
- NCT06488599
- Acronym / sponsor ID
- USJ-2023-20
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 19 participants (estimated)
- Lead sponsor
- Saint-Joseph UniversityUniversity, hospital or other
- Study start
- 15 Dec 2023 (actual)
- Primary completion
- 30 May 2024 (actual)
- Study completion
- 20 Jul 2024 (estimated)
- First posted
- 5 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1- hybrid prosthesis | – | Radiation: Peri-apical radiographs on the implantsPatients having fixed hybrid prosthesis over 4 implants in the mandible for 5 years |
| 2- over denture | – | Radiation: Peri-apical radiographs on the implantsPatients having removable overdenture with locators over 2 implants in the mandible for 5 years |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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)
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peri-apical radiographs on the implantsPeri-apical radiographs on the implants supporting the prosthesis | Radiation | 1- hybrid prosthesis, 2- over denture |
Primary outcome
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
8 secondary outcomes
smoking status
Time frame: 5 years
compliance and attendance to recall sessions
Time frame: 5 years
keratinized tissue hight
Time frame: 5 years
framework design
Time frame: 5 years
age
Time frame: 5 years
health status
Time frame: 5 years
sex
Time frame: 5 years
plaque score
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elies El Hachem, DDS principal investigator
Saint Joseph University of Beirut, Faculty of dental Medicine, Periodontolgy department
Nadim Mokbel, PhD study director
Saint Joseph University of Beirut, Faculty of dental Medicine, Periodontolgy department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bone Loss in Jaw and Dental Implant Failure Nos, run by Saint-Joseph University at 1 site in Lebanon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lebanon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Marginal Bone Loss in mm (MBL) (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2024.