Dental Implant-Abutment DesignsNCT06544746
Association Between Restorative Emergence Profiles and Peri-implant Bone Loss in Different Implant Systems:
An observational study of Dental Implant-Abutment Designs, run by Saint-Joseph University at 1 site in Lebanon.
Trial summary
The goal of this observational study is evaluate the association between different emergence profile angulation on marginal bone loss progression around different implant systems (bone level, tissue level and switching platform). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental Implant-Abutment Designs
- What is being tested?
- Periapical radiographs
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 76 participants
- Where
- 1 siteLebanon
- Study dates
- 1 Dec 2022to 1 Aug 2024
- 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: Patients with implants placed and prosthesis delivered for over 3 years. Implants in the premolar/molar region. Non-smokers. Good oral hygiene. 237 implant surfaces in 76 patients. Follow-up: 3 to 7 years. Study conducted at Saint Joseph University of Beirut.
Who may be able to join
- Patients who have undergone the initial phase followed by implant placement.
- Implants placed and prosthesis delivered for more than 3 years.
- Implants placed in premolar/molar region
- No reconstructive bone procedure done on the site of study
- Presence of opposing occlusion
- Non-smokers
Who cannot join
- Systemic diseases (uncontrolled diabetes, drugs that can affect bone metabolism).
- Total edentulousness.
- Inappropriate, unavailable, or distorted x-rays.
- Implants placed at a supra or infra bone level.
- Implants placed immediately after an extraction.
- Poor oral hygiene (High plaque score FMPS control record > 30%)
Show all 10Show fewer
- Smokers
- Signs of peri-implantitis development during the first year following functional loading
- Lack or incomplete information regarding peri-implant conditions (clinical and radiographic documentation at the required study time-points)
- Surgical treatment on the study implants during the first 2 years after peri-implantitis diagnosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Association Between Restorative Emergence Profiles and Peri-implant Bone Loss in Different Implant Systems: A Retrospective Study With up to 7 Years of Follow up
The goal of this observational study is evaluate the association between different emergence profile angulation on marginal bone loss progression around different implant systems (bone level, tissue level and switching platform).
Does different emergence profile angulation have the same effect on peri-implant marginal bone loss? Standardized periapical radiograph that were captured after crown placement on implants will be compared with the new radiographs done after recalling the patient.
Read the detailed description
The present retrospective study reported the data collected on partially edentulous patients who were restored with fixed implant supported restorations. The implants were inserted in the periodontology department at the Faculty of Dental Medicine at the Saint Joseph University of Beirut, Lebanon, from 2012 to 2019. The study protocol received approval from the Institutional Review Board at Saint Joseph University of Beirut.
Under the guidance of academic members, all surgical procedures were carried out by postgraduate students. For each implant system, the surgical procedure followed the conventional recommendations. Patients got cemented or screw-retained fixed prostheses after adequate healing time of 3 to 6 months.
Patients were urged to practice proper oral hygiene after receiving their final crown. Even though all patients are told to participate in a regular Supportive periodontal therapy program, some of them did not, they were not selected and excluded in this study Patients or implants were excluded under the following conditions: (a) insufficient clinical records; (b) patients with systemic diseases or conditions; (c) smokers; (d) irregular maintenance care; (e) patients with calculus presence on radiographs; (f) implants placed on reconstructed sites; (g) implant-assisted removable prostheses; (h) peri-implantitis diagnosis; (i) failed implants;(j) Bone loss before prothesis delivery (k) previously treated peri-implantitis cases; and (l)Bone level implants placed supracrestally; (m) lack of intra-oral radiographs taken using the paralleling technique at baseline (the first year of prosthesis insertion) and after 3 years.
Patients were called for reassessment appointments after 3-7 years. After signing the informed consent, measurements by a PCP-15(periondontal probe) probe of plaque index (FMPS) and bleeding on probing (FMBS) are indicated on the form. If the smoking status has changed, it is also mentioned.
For data analysis, the following categories were included: implant connection type (bone-level platform switching, bone-level non platform switching, or tissue level); Emergence Angle (mesial and distal, separately); Emergence Profile (mesial and distal, separately); location; history of periodontitis, abutment height. Radiographic and clinical parameters taken at the time implant placement, after prosthetic delivery, and following a minimum of 3 years follow-up visit were provided.
Single and multiple restorations were included.
- Conditions
- Dental Implant-Abutment Designs
- Being tested
- Periapical radiographs
- Keywords
- Bone loss, Emergence profile, Platform switching
- Medical subject headings
- Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Periapical radiographsRadiation
oral radiographs taken with the paralleling technique and film holders at 1- and 3-years post-prosthesis insertion with an X-ray apparatus equipped with a long cone and a Rinn Universal Collimator (Dentsply RINN, York, PA, USA). All radiographs were stored on a PC and analyzed with the software program DBSWIN software. Each radiograph was calibrated using the implant diameter and length as reference measures to correct any distortion before measurement. An image processing program was employed to quantify peri-implant MBL, the EA, EP.
| Study group | Role | What they receive |
|---|---|---|
| Bone level Implants | Marginal bone loss will be assessed according to the emergence profile in each system of implants. Standardized periapical radiograph that were captured after crown placement on implants will be compared with the new radiographs done after recalling the patient. Receives: Radiation: Periapical radiographs | |
| Tissue Level Implants | Marginal bone loss will be assessed according to the emergence profile in each system of implants. Standardized periapical radiograph that were captured after crown placement on implants will be compared with the new radiographs done after recalling the patient. Receives: Radiation: Periapical radiographs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare Marginal Bone Loss (MBL):
measured mesially and distally from the implant platform until the first coronal contact of the bone with the implant. Then the total bone loss on each implant is calculated. This is achieved on the software in millimeters.
Measured: Minimum of 3 years post loading
Compare Emergence angulation assessment
The EA was calculated as the angle between the implant's long axis and a line tangent to the restoration. First, a line parallel to the implant's long axis was drawn at the outer collar of the implant. Then, another line tangential to the restoration from the platform was drawn. The angle of intersection was measured as the emergence angle. Measured in degree
Measured: Minimum of 3 years post loading
Compare Emergence profile assessment:
Each EP was categorized as either concave, straight, or convex.
Measured: Minimum of 3 years post loading
Secondary outcomes (2)
Number of Platform switching
Available or not
Measured: Minimum of 3 years post loading
Height of Abutments
Height measurement of the abutment. Measured in mm
Measured: Minimum of 3 years post loading
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start1 Dec 2022
- Primary completion15 Jul 2024
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Implant-Abutment DesignsStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saint-Joseph University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gabriel Menassa, PHD, Study director, Saint Joseph University Of Beirut
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06544746
- Sponsor's protocol ID
- USJ-2023-63
- Status last verified
- Aug 2024
- First submitted
- 5 Aug 2024
- Last updated
- 13 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Restorative Emergence Profiles and Peri-implant Bone Loss in Different Implant Systems: A Retrospective Study With up to 7 Years of Follow up
- ClinicalTrials.gov ID
- NCT06544746
- Acronym / sponsor ID
- USJ-2023-63
- Conditions
- Dental Implant-Abutment Designs
- Keywords
- Bone loss, Emergence profile, Platform switching
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Saint-Joseph UniversityUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 15 Jul 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 9 Aug 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.
The goal of this observational study is evaluate the association between different emergence profile angulation on marginal bone loss progression around different implant systems (bone level, tissue level and switching platform).
Does different emergence profile angulation have the same effect on peri-implant marginal bone loss? Standardized periapical radiograph that were captured after crown placement on implants will be compared with the new radiographs done after recalling the patient.
Detailed description
The present retrospective study reported the data collected on partially edentulous patients who were restored with fixed implant supported restorations. The implants were inserted in the periodontology department at the Faculty of Dental Medicine at the Saint Joseph University of Beirut, Lebanon, from 2012 to 2019. The study protocol received approval from the Institutional Review Board at Saint Joseph University of Beirut.
Under the guidance of academic members, all surgical procedures were carried out by postgraduate students. For each implant system, the surgical procedure followed the conventional recommendations. Patients got cemented or screw-retained fixed prostheses after adequate healing time of 3 to 6 months.
Patients were urged to practice proper oral hygiene after receiving their final crown. Even though all patients are told to participate in a regular Supportive periodontal therapy program, some of them did not, they were not selected and excluded in this study Patients or implants were excluded under the following conditions: (a) insufficient clinical records; (b) patients with systemic diseases or conditions; (c) smokers; (d) irregular maintenance care; (e) patients with calculus presence on radiographs; (f) implants placed on reconstructed sites; (g) implant-assisted removable prostheses; (h) peri-implantitis diagnosis; (i) failed implants;(j) Bone loss before prothesis delivery (k) previously treated peri-implantitis cases; and (l)Bone level implants placed supracrestally; (m) lack of intra-oral radiographs taken using the paralleling technique at baseline (the first year of prosthesis insertion) and after 3 years.
Patients were called for reassessment appointments after 3-7 years. After signing the informed consent, measurements by a PCP-15(periondontal probe) probe of plaque index (FMPS) and bleeding on probing (FMBS) are indicated on the form. If the smoking status has changed, it is also mentioned.
For data analysis, the following categories were included: implant connection type (bone-level platform switching, bone-level non platform switching, or tissue level); Emergence Angle (mesial and distal, separately); Emergence Profile (mesial and distal, separately); location; history of periodontitis, abutment height. Radiographic and clinical parameters taken at the time implant placement, after prosthetic delivery, and following a minimum of 3 years follow-up visit were provided.
Single and multiple restorations were included.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bone level Implants | – | Radiation: Periapical radiographsMarginal bone loss will be assessed according to the emergence profile in each system of implants. Standardized periapical radiograph that were captured after crown placement on implants will be compared with the new radiographs done after recalling the patient. |
| Tissue Level Implants | – | Radiation: Periapical radiographsMarginal bone loss will be assessed according to the emergence profile in each system of implants. Standardized periapical radiograph that were captured after crown placement on implants will be compared with the new radiographs done after recalling the patient. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with implants placed and prosthesis delivered for over 3 years. Implants in the premolar/molar region. Non-smokers. Good oral hygiene. 237 implant surfaces in 76 patients. Follow-up: 3 to 7 years. Study conducted at Saint Joseph University of Beirut.
Key inclusion criteria (6 listed)
- Patients who have undergone the initial phase followed by implant placement.
- Implants placed and prosthesis delivered for more than 3 years.
- Implants placed in premolar/molar region
- No reconstructive bone procedure done on the site of study
- Presence of opposing occlusion
Key exclusion criteria (10 listed)
- Systemic diseases (uncontrolled diabetes, drugs that can affect bone metabolism).
- Total edentulousness.
- Inappropriate, unavailable, or distorted x-rays.
- Implants placed at a supra or infra bone level.
- Implants placed immediately after an extraction.
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 radiographsoral radiographs taken with the paralleling technique and film holders at 1- and 3-years post-prosthesis insertion with an X-ray apparatus equipped with a long cone and a Rinn Universal Collimator (Dentsply RINN, York, PA, USA). All radiographs were stored on a PC and analyzed with the software program DBSWIN software. Each radiograph was calibrated using the implant diameter and length as reference measures to correct any distortion before measurement. An image processing program was employed to quantify peri-implant MBL, the EA, EP. | Radiation | Bone level Implants, Tissue Level Implants |
Primary outcome
Compare Marginal Bone Loss (MBL):
Time frame: Minimum of 3 years post loading
measured mesially and distally from the implant platform until the first coronal contact of the bone with the implant. Then the total bone loss on each implant is calculated. This is achieved on the software in millimeters.
Compare Emergence angulation assessment
Time frame: Minimum of 3 years post loading
The EA was calculated as the angle between the implant's long axis and a line tangent to the restoration. First, a line parallel to the implant's long axis was drawn at the outer collar of the implant. Then, another line tangential to the restoration from the platform was drawn. The angle of intersection was measured as the emergence angle. Measured in degree
Compare Emergence profile assessment:
Time frame: Minimum of 3 years post loading
Each EP was categorized as either concave, straight, or convex.
2 secondary outcomes
Number of Platform switching
Time frame: Minimum of 3 years post loading
Height of Abutments
Time frame: Minimum of 3 years post loading
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2024.
- Individual participant dataSharing planned: No
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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.
Gabriel Menassa, PHD study director
Saint Joseph University Of Beirut
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 Dental Implant-Abutment Designs, 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 10 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: finished, as of the sponsor's last update on 13 Aug 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Compare Marginal Bone Loss (MBL): (time frame: Minimum of 3 years post loading). The study lists 3 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 13 Aug 2024.