Peri-implant Bone LossNCT04761445
Comparison Between Two Different Tissue-Level Implant Systems: A Prospective Clinical Study
A study testing Straumann Standard Plus implant and JDental care (JD) Octa implant in people with Peri-implant Bone Loss and Implant Stability, run by Saint-Joseph University at 1 site in Lebanon.
Trial summary
The objective of this prospective study is to compare clinically and radiographically two different tissue-level implants, in partially edentulous patients in the posterior area of the maxilla and mandible. The primary objective of the study was to track the crestal bone level changes around the two implant systems. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Peri-implant Bone Loss, Implant Stability, Vertical Soft Tissue Thickness
- What is being tested?
- Straumann Standard Plus implant and JDental care (JD) Octa implant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteLebanon
- Study dates
- 10 Jan 2019to 10 Jul 2021
- Phase
- Interventional
- 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
Who may be able to join
- Patients over the age of 18, requiring placement of at least two adjacent implants in the posterior maxilla or mandible (premolar-molar area)
- Patients willing to sign the consent form and respect the follow-up period of the study
- Non-smokers or light smokers (less than 10 cig/day)
- No bone augmentation procedures before or during implant placement in the area of interest
- Healthy soft tissue conditions (full mouth plaque scores < 20% and full mouth bleeding index < 20%)
- Minimum height of 2 mm of keratinized tissue
Show all 9Show fewer
- Minimum of 6 mm in bone width and 10 mm in bone height
- Minimal distance of 2 mm between predicted implant tip and inferior alveolar nerve
- Healed sockets (at least 4 months post-extraction)
Who cannot join
- Patients not satisfying the inclusion criteria
- Patients with any local or systemic disease
- Patients taking any kind of medication that interferes with bone metabolism
- Pregnant or breast-feeding women
- Patients with parafunctional disorders
- Patients with poor oral hygiene
- Heavy smokers (>10 cig/day)
Trial locations and contacts
1 site in 1 country.
About this study
The objective of this prospective study is to compare clinically and radiographically two different tissue-level implants, in partially edentulous patients in the posterior area of the maxilla and mandible. The primary objective of the study was to track the crestal bone level changes around the two implant systems. Secondary objectives were implant stability as well as initial soft tissue thickness which were evaluated throughout this study.
Read the detailed description
The study is designed as a prospective clinical trial with a parallel design comparing two different tissue-level implants placed adjacently in the posterior maxilla and mandible. The primary outcome is the change in the interproximal crestal bone level.
Patients in this study were recruited from the general population attending the department of Periodontology at the Saint-Joseph University. Adult patients (males and females) in need of implant rehabilitation for partial edentulism in the posterior maxilla and mandible have been selected to take part in this study. Following initial screening procedures, each patient underwent a site-specific intraoral and radiographic examination (Cone Beam Computed Tomography analysis and periapical radiographs) in order to make sure that the inclusion criteria were satisfied. Patients presenting with bone width of less than 6 mm or more than 9 mm were immediately excluded from the study. The day of the surgery, each implantation site was given a number depending on the tooth missing. Then, using a random team generator software each site was randomly assigned to one of the two groups based on the implant system used:
The first group (group 1) consisted of patients receiving Straumann Standard Plus (SP) implants of 4.1 mm in diameter and length of 10 mm.
The second group (group 2) included patients receiving JD Octa implants of 4.3 mm in diameter and 10 mm in length.
Participants were blinded as to the assignment in the first or second group. The implant placement procedures were planned based on clinical and radiographic evaluation.
The following parameters were monitored for each case:
Crestal bone level changes (CBL)
Primary and secondary implant stability
Initial soft tissue thickness
After a healing time of 3 months Patients were recalled 6 and 12 months after prosthetic treatment. At each visit, the restorations were evaluated for mobility, oral hygiene, peri-implant soft tissue conditions and patient satisfaction. Intraoral standardized radiographs were also taken at the 12-months follow-up visit to evaluate crestal bone level changes. CBL changes were defined as the difference between two consecutive CBL measurements. Secondary implant stability was evaluated. Impressions were taken at the implant level. Abutments were fixed on the implants with titanium screws.
In order to reduce the risk of bias in the study, all the implant-supported crowns were screw retained. However, in only one case, and due to prosthetic considerations, two implant-supported crowns were cemented using a temporary cement. In this case, the restorations were thoroughly checked for excessive cement.
Final restorations were delivered within 2 weeks of referral. Finally, standardized radiographs were taken to ensure abutment seating and check for residual cement (in the case of cemented crowns).
Patients were recalled 6 and 12 months after prosthetic treatment. At each visit, the restorations were evaluated for mobility, oral hygiene, peri-implant soft tissue conditions and patient satisfaction. Intraoral standardized radiographs were also taken at the 12-months follow-up visit to evaluate crestal bone level changes. As described previously, CBL changes were defined as the difference between two consecutive CBL measurements.
- Being tested
- Straumann Standard Plus implant and JDental care (JD) Octa implant
- Keywords
- Marginal bone loss, Crestal bone stability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Straumann Standard Plus implant and JDental care (JD) Octa implantOther
Also called Straumann SP implants, JD Octa implants (J Dental Care)
Two different implant systems were used. The above-mentioned implants share many features in common, such as implant design. They both have a machined implant collar of 1.8 mm.
| Study group | Role | What they receive |
|---|---|---|
| Straumann Standard Plus (SP) | Experimental | Patients receiving Straumann SP implants of 4.1 mm in diameter and length of 10 mm. Receives: Other: Straumann Standard Plus implant and JDental care (JD) Octa implant |
| JDental care Octa (JD Octa) | Experimental | Patients receiving JD Octa implants of 4.3 mm in diameter and 10 mm in length. Receives: Other: Straumann Standard Plus implant and JDental care (JD) Octa implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Crestal bone level changes.
Peri-implant CBL changes were assessed using periapical radiographs. Radiographs were taken according to the long cone, paralleling technique, using a positioner (XCP Rinn holders, Dentsply Friadent Schweiz, Nidau, Switzerland) parallel to the implant axis and perpendicular to the cone of rays. An individualized radiographic mount (foam and acrylic) was used for each patient to standardize the periapical radiographs. This technique allows the repositioning of the image plate in future radiologic examinations. For the digital process, an image measuring program, Image J (Wayne Rasband, National Institutes of Health) was used.
Measured: Radiographic evaluation took place at three time periods: at implant placement, at implant loading and one year after implant loading.
Secondary outcomes (2)
Initial soft tissue thickness.
Vertical soft tissue thickness was measured with a periodontal probe (PCP-UNC 15; Hu-Friedy, Chicago, IL) placed at the center of the future implant site after full thickness buccal flap elevation.
Measured: Vertical soft tissue thickness was measured immediately during the implant placement.
Primary and secondary implant stability.
Primary and secondary implant stability were measured with Osstell ISQ (Osstell AB, Gothenburg, Sweden).
Measured: Primary and secondary implant stability were measured immediately after implant placement (t1) and after 3 months (t2) respectively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start10 Jan 2019
- Primary completion10 Jul 2020
- Study completion10 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peri-implant Bone LossStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study is designed as a prospective clinical trial with a parallel design comparing two different tissue-level implants placed adjacently in the posterior maxilla and mandible.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saint-Joseph University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sandrine Abi Rached, Saint-Joseph University
- Investigators
- Carole Chakar, DDS, PhD, Study director, Head of the department of periodontology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04761445
- Sponsor's protocol ID
- FMD187
- Status last verified
- Aug 2021
- First submitted
- 16 Dec 2020
- Last updated
- 3 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Study protocol
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Two Different Tissue-Level Implant Systems: A Prospective Clinical Study
- ClinicalTrials.gov ID
- NCT04761445
- Acronym / sponsor ID
- FMD187
- Keywords
- Marginal bone loss, Crestal bone stability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Saint-Joseph UniversityUniversity, hospital or other
- Study start
- 10 Jan 2019 (actual)
- Primary completion
- 10 Jul 2020 (actual)
- Study completion
- 10 Jul 2021 (actual)
- First posted
- 21 Feb 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 objective of this prospective study is to compare clinically and radiographically two different tissue-level implants, in partially edentulous patients in the posterior area of the maxilla and mandible. The primary objective of the study was to track the crestal bone level changes around the two implant systems. Secondary objectives were implant stability as well as initial soft tissue thickness which were evaluated throughout this study.
Detailed description
The study is designed as a prospective clinical trial with a parallel design comparing two different tissue-level implants placed adjacently in the posterior maxilla and mandible. The primary outcome is the change in the interproximal crestal bone level.
Patients in this study were recruited from the general population attending the department of Periodontology at the Saint-Joseph University. Adult patients (males and females) in need of implant rehabilitation for partial edentulism in the posterior maxilla and mandible have been selected to take part in this study. Following initial screening procedures, each patient underwent a site-specific intraoral and radiographic examination (Cone Beam Computed Tomography analysis and periapical radiographs) in order to make sure that the inclusion criteria were satisfied. Patients presenting with bone width of less than 6 mm or more than 9 mm were immediately excluded from the study. The day of the surgery, each implantation site was given a number depending on the tooth missing. Then, using a random team generator software each site was randomly assigned to one of the two groups based on the implant system used:
The first group (group 1) consisted of patients receiving Straumann Standard Plus (SP) implants of 4.1 mm in diameter and length of 10 mm.
The second group (group 2) included patients receiving JD Octa implants of 4.3 mm in diameter and 10 mm in length.
Participants were blinded as to the assignment in the first or second group. The implant placement procedures were planned based on clinical and radiographic evaluation.
The following parameters were monitored for each case:
Crestal bone level changes (CBL)
Primary and secondary implant stability
Initial soft tissue thickness
After a healing time of 3 months Patients were recalled 6 and 12 months after prosthetic treatment. At each visit, the restorations were evaluated for mobility, oral hygiene, peri-implant soft tissue conditions and patient satisfaction. Intraoral standardized radiographs were also taken at the 12-months follow-up visit to evaluate crestal bone level changes. CBL changes were defined as the difference between two consecutive CBL measurements. Secondary implant stability was evaluated. Impressions were taken at the implant level. Abutments were fixed on the implants with titanium screws.
In order to reduce the risk of bias in the study, all the implant-supported crowns were screw retained. However, in only one case, and due to prosthetic considerations, two implant-supported crowns were cemented using a temporary cement. In this case, the restorations were thoroughly checked for excessive cement.
Final restorations were delivered within 2 weeks of referral. Finally, standardized radiographs were taken to ensure abutment seating and check for residual cement (in the case of cemented crowns).
Patients were recalled 6 and 12 months after prosthetic treatment. At each visit, the restorations were evaluated for mobility, oral hygiene, peri-implant soft tissue conditions and patient satisfaction. Intraoral standardized radiographs were also taken at the 12-months follow-up visit to evaluate crestal bone level changes. As described previously, CBL changes were defined as the difference between two consecutive CBL measurements.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The study is designed as a prospective clinical trial with a parallel design comparing two different tissue-level implants placed adjacently in the posterior maxilla and mandible.
| Arm | Type | Receives |
|---|---|---|
| Straumann Standard Plus (SP) | Experimental | Other: Straumann Standard Plus implant and JDental care (JD) Octa implantPatients receiving Straumann SP implants of 4.1 mm in diameter and length of 10 mm. |
| JDental care Octa (JD Octa) | Experimental | Other: Straumann Standard Plus implant and JDental care (JD) Octa implantPatients receiving JD Octa implants of 4.3 mm in diameter and 10 mm in length. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients over the age of 18, requiring placement of at least two adjacent implants in the posterior maxilla or mandible (premolar-molar area)
- Patients willing to sign the consent form and respect the follow-up period of the study
- Non-smokers or light smokers (less than 10 cig/day)
- No bone augmentation procedures before or during implant placement in the area of interest
- Healthy soft tissue conditions (full mouth plaque scores < 20% and full mouth bleeding index < 20%)
Key exclusion criteria (7 listed)
- Patients not satisfying the inclusion criteria
- Patients with any local or systemic disease
- Patients taking any kind of medication that interferes with bone metabolism
- Pregnant or breast-feeding women
- Patients with parafunctional disorders
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 |
|---|---|---|
| Straumann Standard Plus implant and JDental care (JD) Octa implantAlso: Straumann SP implants, JD Octa implants (J Dental Care)Two different implant systems were used. The above-mentioned implants share many features in common, such as implant design. They both have a machined implant collar of 1.8 mm. | Other | JDental care Octa (JD Octa), Straumann Standard Plus (SP) |
Primary outcome
Crestal bone level changes.
Time frame: Radiographic evaluation took place at three time periods: at implant placement, at implant loading and one year after implant loading.
Peri-implant CBL changes were assessed using periapical radiographs. Radiographs were taken according to the long cone, paralleling technique, using a positioner (XCP Rinn holders, Dentsply Friadent Schweiz, Nidau, Switzerland) parallel to the implant axis and perpendicular to the cone of rays. An individualized radiographic mount (foam and acrylic) was used for each patient to standardize the periapical radiographs. This technique allows the repositioning of the image plate in future radiologic examinations. For the digital process, an image measuring program, Image J (Wayne Rasband, National Institutes of Health) was used.
2 secondary outcomes
Initial soft tissue thickness.
Time frame: Vertical soft tissue thickness was measured immediately during the implant placement.
Primary and secondary implant stability.
Time frame: Primary and secondary implant stability were measured immediately after implant placement (t1) and after 3 months (t2) respectively.
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 3 Aug 2021.
- Individual participant dataSharing planned: No. Study protocol
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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.
Carole Chakar, DDS, PhD study director
Head of the department of periodontology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Straumann Standard Plus implant and JDental care (JD) Octa implant in people with Peri-implant Bone Loss and Implant Stability, 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 9 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: finished, as of the sponsor's last update on 3 Aug 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?
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?
Crestal bone level changes. (time frame: Radiographic evaluation took place at three time periods: at implant placement, at implant loading and one year after implant loading.). 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 3 Aug 2021.