PeriimplantitisNCT04942808
A Study of the Crestal Bone Loss Around Bone Level Versus Tissue Level Implants in Non-compliant Patients With Healthy or Reduced Periodontium After 5-8 Years in Function
An observational study of Periimplantitis and Marginal Bone Loss, run by Saint-Joseph University at 1 site in Lebanon.
Trial summary
The goal is to evaluate, after 5 to 8 years, the marginal bone loss around tissue-level implants and bone-level implants in patients who have not followed the maintenance program. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Periimplantitis, Marginal Bone Loss
- What is being tested?
- Periapical radiographs
- Type of treatment
- Surgery or procedure
- How many people
- 130 participants
- Where
- 1 siteLebanon
- Study dates
- 1 Jun 2021to 29 Jul 2022
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All patients who had implants between 2012 and 2015 and who did not follow a maintenance program and whose inclusion criteria are present will be included in the study.
Who may be able to join
- Patients who have undergone the initial phase followed by implant placement in the posterior region.
- Implants placed for more than 5 years.
- The implant systems selected are:
- Tissue Level Implants: Straumann (Straumann Dental Implants System, Switzerland),
- Bone Level implants: Branemark, 3i Biomet (external and internal connection), Nobel replace and Astra.
- Patients who did not comply with the maintenance program and who missed more than 30% of appointments.
Who cannot join
- Systemic diseases (uncontrolled diabetes, drugs which may affect bone metabolism).
- Totally edentulous.
- Severe periodontitis not stabilized
- Inappropriate, unavailable or distorted x-rays.
- Augmented sites.
- Implants placed at a supra or infraosseous level.
- Implants placed immediately after extraction.
Trial locations and contacts
1 site in 1 country.
Lebanon1 site, 1 recruiting
- Recruiting
Saint Joseph University of Beirut
Beirut, Mount Lebanon
Layal Bou Semaan, DDS, +96178898880, layal.bs@live.com
About this study
Official title: A Comparative Observational Study of the Crestal Bone Loss Around Bone Level Versus Tissue Level Implants in Non-compliant Patients With Healthy or Reduced Periodontium After 5-8 Years in Function"
The goal is to evaluate, after 5 to 8 years, the marginal bone loss around tissue-level implants and bone-level implants in patients who have not followed the maintenance program.
Medical records of patients who have been implanted for at least 5 to 8 years and who have been lost during this period are collected from three private clinics in Beirut,Lebanon and the Saint Joseph University Health Center in Beirut,Lebanon.
Read more
On an individual sheet, the patient as well as the implants data will be noted. Patients will be called for reevaluation after 5-8 years. After signing the informed consent, the measurements by a PCP-15 probe of the plaque index (FMPS) and the bleeding index (FMBS) as well as the height of the keratinized tissue are indicated on the sheet. If the smoking status has changed, this will be mentioned too.
The marginal bone loss will be measured on the X-rays taken immediately after the implant placement, after 1 year of loading and then at the reevaluation session.
Read the detailed description
On the individual sheet for each patient, the data concerning the name, age, sex, general condition, smoking status, periodontal status , the number of follow-up sessions and the plaque index as well as bleeding on probing (if noted in the file before placing the implants) will be recorded.
Then, the data concerning the implant such as the site (maxilla or mandibular), the type of implant, the length, the diameter, the surface, sealed or screwed, presence of a cantilever, hiatus or over-contour, a one or two surgical time, the date of placement and the number of years of operation will also be noted on the form.
Patients will be called for reassessment appointments after 5-8 years. After signing the informed consent, the measurements by a PCP-15 periodontal probe of the plaque index (FMPS), bleeding on probing (FMBS) as well as the height and thickness of the keratinized mucosa are indicated on the sheet. The smoking status will also be updated and indicated.
Implants will be classified into one of these groups:
- Patients with tissue implants (TL).
- Patients with bone level implants with internal connection (BL, Internal hex).
- Patients with bone level implants with external connection (BL, External hex).
X-rays taken after insertion, after 1 year of loading and after 5-8 years will be collected and analyzed on the DBSWIN software. Mesial and distal bone loss after implant placement and after 5 to 8 years will be measured on retro-alveolar radiographs with calibration and recorded on the patient file. The total bone loss will then be calculated.
The radiographic measurement technique is as follows. The platform of the mesial and distal implant (MIS: Mesial Implant Shoulder and DIS: Distal Implant Shoulder) will be defined and a line (A) connecting the two is drawn. Another line (B) tangential to the apex of the implant and parallel to A is also drawn. The bisecting line at A and B is therefore produced and measured to assess the distorted implant length (DIL: Distorted Implant Length). Bone level (BL) measurements will be recorded from the implant platform (MIS-DIS) to the most coronary bone-to-implant contact (BIC) on the mesial and distal sides of each implant. The length of the implant will be used as an actual measurement to calibrate the other measurements.
- Conditions
- Periimplantitis, Marginal Bone Loss
- Being tested
- Periapical radiographs
- Keywords
- Oral hygiene, Dental implant, Periodontal maintenance, Marginal bone loss, Tissue level implant, Bone level implant, Internal connection, External connection
- Medical subject headings
- Peri-Implantitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Periapical radiographsRadiation
Periapical radiographs on reevaluation
What is being measured
The primary outcome is the main question the study is designed to answer.
Marginal bone loss
It will be measured mesially and distally on each implant platform until the bone's first coronal contact with the implant. Then, the total bone loss on each implant will be calculated. This is done on the software in millimeters.
Measured: 5 to 8 years
Level of oral hygiene
The second factor studied is the level of hygiene which will be calculated by measuring the plaque index and bleeding on probing. This is done with a PCP-15 periodontal probe by a light sweeping movement at the level of the 4 sites of each tooth and implant and then written on the personalized card for each patient.
Measured: 5 to 8 years
Secondary outcomes (8)
Smoking status
Non-smoker, smoker <10 cig/d, smoker equal or > to 10 cig/d, Former smoker
Measured: 5 to 8 years
Periodontal status
Gingivitis or periodontitis with stage and grade
Measured: 5 to 8 years
success and survival of the implant
- absence of persistent pain, dysesthesia or paresthesia 2) absence of peri-implant infection with or without suppuration 3) absence of noticeable mobility of the implant and 4) absence of persistent peri-implant bone resorption> 1.5 mm during the first year of loading and 0.2 mm per year for the following years.
Measured: 5 to 8 years
Years in function
Years in function
Measured: 5 to 8 years
Height and thickness of the peri-implant keratinized mucosa
Height and thickness of the peri-implant keratinized mucosa
Measured: 5 to 8 years
Overhang or hiatus or cantilever
Overhang or hiatus or cantilever
Measured: 5 to 8 years
Full mouth plaque score
With a periodontal probe, we measure at 4 sites (vestibular, mesial, distal, palatine / lingual) of each implant and tooth, we note 0 / - in the absence of plaque and 1 / + in the presence of plaque.
Measured: 1 year
Full mouth bleeding score
With a periodontal probe and after a gentle sweeping motion over the marginal surface of the implant, detect the presence or absence of bleeding at the 4 sites of each implant and tooth denoted by 1 / + and 0 / - respectively.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2021
- Study start1 Jun 2021
- Primary completion29 May 2022 (estimated)
- Study completion29 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriimplantitisStudies 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saint-Joseph University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Layal Bou Semaan, Saint-Joseph University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04942808
- Sponsor's protocol ID
- FMDA9/21
- Status last verified
- Jun 2021
- First submitted
- 16 Jun 2021
- Last updated
- 28 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Observational Study of the Crestal Bone Loss Around Bone Level Versus Tissue Level Implants in Non-compliant Patients With Healthy or Reduced Periodontium After 5-8 Years in Function"
- ClinicalTrials.gov ID
- NCT04942808
- Acronym / sponsor ID
- FMDA9/21
- Conditions
- Periimplantitis, Marginal Bone Loss
- Keywords
- Oral hygiene, Dental implant, Periodontal maintenance, Marginal bone loss, Tissue level implant, Bone level implant, Internal connection, External connection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Saint-Joseph UniversityUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 29 May 2022 (estimated)
- Study completion
- 29 Jul 2022 (estimated)
- First posted
- 28 Jun 2021 (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.
The goal is to evaluate, after 5 to 8 years, the marginal bone loss around tissue-level implants and bone-level implants in patients who have not followed the maintenance program.
Medical records of patients who have been implanted for at least 5 to 8 years and who have been lost during this period are collected from three private clinics in Beirut,Lebanon and the Saint Joseph University Health Center in Beirut,Lebanon.
On an individual sheet, the patient as well as the implants data will be noted. Patients will be called for reevaluation after 5-8 years. After signing the informed consent, the measurements by a PCP-15 probe of the plaque index (FMPS) and the bleeding index (FMBS) as well as the height of the keratinized tissue are indicated on the sheet. If the smoking status has changed, this will be mentioned too.
The marginal bone loss will be measured on the X-rays taken immediately after the implant placement, after 1 year of loading and then at the reevaluation session.
Detailed description
On the individual sheet for each patient, the data concerning the name, age, sex, general condition, smoking status, periodontal status , the number of follow-up sessions and the plaque index as well as bleeding on probing (if noted in the file before placing the implants) will be recorded.
Then, the data concerning the implant such as the site (maxilla or mandibular), the type of implant, the length, the diameter, the surface, sealed or screwed, presence of a cantilever, hiatus or over-contour, a one or two surgical time, the date of placement and the number of years of operation will also be noted on the form.
Patients will be called for reassessment appointments after 5-8 years. After signing the informed consent, the measurements by a PCP-15 periodontal probe of the plaque index (FMPS), bleeding on probing (FMBS) as well as the height and thickness of the keratinized mucosa are indicated on the sheet. The smoking status will also be updated and indicated.
Implants will be classified into one of these groups:
- Patients with tissue implants (TL).
- Patients with bone level implants with internal connection (BL, Internal hex).
- Patients with bone level implants with external connection (BL, External hex).
X-rays taken after insertion, after 1 year of loading and after 5-8 years will be collected and analyzed on the DBSWIN software. Mesial and distal bone loss after implant placement and after 5 to 8 years will be measured on retro-alveolar radiographs with calibration and recorded on the patient file. The total bone loss will then be calculated.
The radiographic measurement technique is as follows. The platform of the mesial and distal implant (MIS: Mesial Implant Shoulder and DIS: Distal Implant Shoulder) will be defined and a line (A) connecting the two is drawn. Another line (B) tangential to the apex of the implant and parallel to A is also drawn. The bisecting line at A and B is therefore produced and measured to assess the distorted implant length (DIL: Distorted Implant Length). Bone level (BL) measurements will be recorded from the implant platform (MIS-DIS) to the most coronary bone-to-implant contact (BIC) on the mesial and distal sides of each implant. The length of the implant will be used as an actual measurement to calibrate the other measurements.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All patients who had implants between 2012 and 2015 and who did not follow a maintenance program and whose inclusion criteria are present will be included in the study.
Key inclusion criteria (6 listed)
- Patients who have undergone the initial phase followed by implant placement in the posterior region.
- Implants placed for more than 5 years.
- The implant systems selected are:
- Patients who did not comply with the maintenance program and who missed more than 30% of appointments.
Key exclusion criteria (7 listed)
- Systemic diseases (uncontrolled diabetes, drugs which may affect bone metabolism).
- Totally edentulous.
- Severe periodontitis not stabilized
- Inappropriate, unavailable or distorted x-rays.
- Augmented sites.
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 |
|---|---|---|
| Periapical radiographsPeriapical radiographs on reevaluation | Radiation | – |
Primary outcome
Marginal bone loss
Time frame: 5 to 8 years
It will be measured mesially and distally on each implant platform until the bone's first coronal contact with the implant. Then, the total bone loss on each implant will be calculated. This is done on the software in millimeters.
Level of oral hygiene
Time frame: 5 to 8 years
The second factor studied is the level of hygiene which will be calculated by measuring the plaque index and bleeding on probing. This is done with a PCP-15 periodontal probe by a light sweeping movement at the level of the 4 sites of each tooth and implant and then written on the personalized card for each patient.
8 secondary outcomes
Smoking status
Time frame: 5 to 8 years
Periodontal status
Time frame: 5 to 8 years
success and survival of the implant
Time frame: 5 to 8 years
Years in function
Time frame: 5 to 8 years
Height and thickness of the peri-implant keratinized mucosa
Time frame: 5 to 8 years
Overhang or hiatus or cantilever
Time frame: 5 to 8 years
Full mouth plaque score
Time frame: 1 year
Full mouth bleeding score
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2021.
- Individual participant dataSharing planned: Yes
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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.
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 Periimplantitis and Marginal Bone Loss, 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 6 inclusion and 7 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 28 Jun 2021. 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?
Contact Layal Bou Semaan, DDS (+96178898880, layal.bs@live.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Marginal bone loss (time frame: 5 to 8 years). The study lists 2 primary outcomes in all. 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 28 Jun 2021.