Dental ImplantNCT06138392
Long-term Study in Early Loaded Hydrophilic Surface Implants
An observational study of Dental Implant, run by University of Bern at 1 site in Switzerland.
Trial summary
Objective: To assess the clinical outcomes and patient satisfaction of early loaded implants with a hydrophilic, moderately rough surface for partially edentulous patients after a follow-up of 8.5 to 9.5 years. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Implant
- What is being tested?
- Dental implant (ELEMENT RC INICELL, Thommen Medical)
- Type of treatment
- Medical device
- How many people
- 12 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Sep 2020to 1 Dec 2021
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients treated in an University Clinic
Who may be able to join
- Individuals between the ages of 18 and 75 years (inclusive)
- Partially edentulous patients with missing teeth in the posterior mandible (positions 34-37 and 44-47) and a healed site at least four weeks after tooth extraction
- Patients requiring a single dental implant
- Patients with physical status 1 or 2 according to the American Society of Anesthesiologists Classification System
- Inadequate native bone quality and quantity to place implants with a diameter of ≥4.0 mm
- Removable prosthesis or complete dentures in the antagonizing dentition
- Written informed consent
Who cannot join
- Patients with compromised general health contraindicating surgical intervention
- Presence of conditions requiring chronic routine prophylactic or prolonged use of antibiotics
- Heavy smokers (exceeding ten cigarettes/day or equivalent) and chewing tobacco users
- Pregnancy or childbearing potential with a positive urine pregnancy test
- Insufficient oral hygiene, untreated periodontitis (any residual pockets >4 mm), or persistent intra-oral infection
- Mucosal diseases such as erosive lichen planus
- Patients with severe bruxism or clenching habits
- Unwillingness to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical and Radiographic Performance of Early Loaded Dental Implants With a Conditioned Hydrophilic Surface: A Prospective Cohort Study With an 8.5- to 9.5-year Follow-up
Objective: To assess the clinical outcomes and patient satisfaction of early loaded implants with a hydrophilic, moderately rough surface for partially edentulous patients after a follow-up of 8.5 to 9.5 years.
Materials and methods: A prospective observational single-centre study involving 15 patients with single, delayed placement and early loaded implants in the posterior area was performed. Clinical and radiographical parameters, including biological and technical complications and patient satisfaction, were assessed.
- Conditions
- Dental Implant
- Being tested
- Dental implant (ELEMENT RC INICELL, Thommen Medical)
- Keywords
- Dental implant, Implant crowns, Hydrophilic implant surface, Early loading, Late implant placement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental implant (ELEMENT RC INICELL, Thommen Medical)Device
Dental implant
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Not described Receives: Device: Dental implant (ELEMENT RC INICELL, Thommen Medical) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical performance - survival
Survival was classified as the continued presence of both the implant and reconstruction in the mouth with no need of replacement and/or repair
Measured: 10 years
Clinical performance - implant success
Implant success was classified as the absence of persisting subjective discomfort (patient compliance), lack of recurrent peri-implant infection with suppuration (European Federation of Periodontology 2018), absence of implant mobility on manual palpation, absence of any continuous peri-implant radiolucency at the radiological assessment.
Measured: 10 years
Clinical performance - prosthetic success
Prosthetic success was defined as the absence of technical complications without needing any reconstruction repair.
Measured: 10 years
Clinical performance - complications
A visual exploration of each implant and reconstruction was performed to detect any biological and technical complications.
Measured: 10 years
Clinical performance - peri-implant health
During the clinical follow-up appointments, peri-implant health was evaluated by using a periodontal probe.
Periodontal pockets (1-20) All parameters were evaluated mesially, distally, buccally, and orally in each implant; following the EFP guidelines (European Federation of Periodontology 2018).
Measured: 10 years
Clinical performance - peri-implant health
During the clinical follow-up appointments, peri-implant health was evaluated by using a periodontal probe.
Plaque index (1-3) All parameters were evaluated mesially, distally, buccally, and orally in each implant; following the EFP guidelines (European Federation of Periodontology 2018).
Measured: 10 years
Clinical performance - peri-implant health
During the clinical follow-up appointments, peri-implant health was evaluated by using a periodontal probe.
Bleeding on probing (yes/no) All parameters were evaluated mesially, distally, buccally, and orally in each implant; following the EFP guidelines (European Federation of Periodontology 2018).
Measured: 10 years
Clinical performance - peri-implant health
During the clinical follow-up appointments, peri-implant health was evaluated by using a periodontal probe.
Pus (yes/no) All parameters were evaluated mesially, distally, buccally, and orally in each implant; following the EFP guidelines (European Federation of Periodontology 2018).
Measured: 10 years
Clinical performance - peri-implant health
During the clinical follow-up appointments, peri-implant health was evaluated by using a periodontal probe.
Keratinized mucosa (mm) All parameters were evaluated mesially, distally, buccally, and orally in each implant; following the EFP guidelines (European Federation of Periodontology 2018).
Measured: 10 years
Clinical performance - PIBL, implant-crown fit
To assess Peri-implant Bone Level (mm), a standardized digital periapical radiograph was taken at the scheduled follow-up visits.
An independent examiner performed a radiological linear evaluation (mm) using image analysis software (ImageJ)
Measured: 10 years
Clinical performance - PIBL, implant-crown fit
To assess implant-crown fit (misfit yes/no), a standardized digital periapical radiograph was taken at the scheduled follow-up visits.
An independent examiner performed a radiological linear evaluation (mm) using image analysis software (ImageJ)
Measured: 10 years
Clinical performance
Patient satisfaction with the implant treatment was evaluated using a 10 cm visual analogue scale (VAS). From 0 (The worst) to 10 (The best).
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start1 Sep 2020
- Primary completion1 Sep 2021
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental ImplantStudies 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
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martin Schimmel, Prof, Study chair, University of Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06138392
- Sponsor's protocol ID
- Performance of early loading
- Status last verified
- Nov 2023
- First submitted
- 10 Oct 2023
- Last updated
- 18 Nov 2023
- 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 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Performance of Early Loaded Dental Implants With a Conditioned Hydrophilic Surface: A Prospective Cohort Study With an 8.5- to 9.5-year Follow-up
- ClinicalTrials.gov ID
- NCT06138392
- Acronym / sponsor ID
- Performance of early loading
- Conditions
- Dental Implant
- Keywords
- Dental implant, Implant crowns, Hydrophilic implant surface, Early loading, Late implant placement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of BernUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 18 Nov 2023 (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.
Objective: To assess the clinical outcomes and patient satisfaction of early loaded implants with a hydrophilic, moderately rough surface for partially edentulous patients after a follow-up of 8.5 to 9.5 years.
Materials and methods: A prospective observational single-centre study involving 15 patients with single, delayed placement and early loaded implants in the posterior area was performed. Clinical and radiographical parameters, including biological and technical complications and patient satisfaction, were assessed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental group | – | Device: Dental implant (ELEMENT RC INICELL, Thommen Medical) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated in an University Clinic
Key inclusion criteria (7 listed)
- Individuals between the ages of 18 and 75 years (inclusive)
- Partially edentulous patients with missing teeth in the posterior mandible (positions 34-37 and 44-47) and a healed site at least four weeks after tooth extraction
- Patients requiring a single dental implant
- Patients with physical status 1 or 2 according to the American Society of Anesthesiologists Classification System
- Inadequate native bone quality and quantity to place implants with a diameter of ≥4.0 mm
Key exclusion criteria (8 listed)
- Patients with compromised general health contraindicating surgical intervention
- Presence of conditions requiring chronic routine prophylactic or prolonged use of antibiotics
- Heavy smokers (exceeding ten cigarettes/day or equivalent) and chewing tobacco users
- Pregnancy or childbearing potential with a positive urine pregnancy test
- Insufficient oral hygiene, untreated periodontitis (any residual pockets >4 mm), or persistent intra-oral infection
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 |
|---|---|---|
| Dental implant (ELEMENT RC INICELL, Thommen Medical)Dental implant | Device | Experimental group |
Primary outcome
Clinical performance - survival
Time frame: 10 years
Survival was classified as the continued presence of both the implant and reconstruction in the mouth with no need of replacement and/or repair
Clinical performance - implant success
Time frame: 10 years
Implant success was classified as the absence of persisting subjective discomfort (patient compliance), lack of recurrent peri-implant infection with suppuration (European Federation of Periodontology 2018), absence of implant mobility on manual palpation, absence of any continuous peri-implant radiolucency at the radiological assessment.
Clinical performance - prosthetic success
Time frame: 10 years
Prosthetic success was defined as the absence of technical complications without needing any reconstruction repair.
Clinical performance - complications
Time frame: 10 years
A visual exploration of each implant and reconstruction was performed to detect any biological and technical complications.
Clinical performance - peri-implant health
Time frame: 10 years
During the clinical follow-up appointments, peri-implant health was evaluated by using a periodontal probe. Periodontal pockets (1-20) All parameters were evaluated mesially, distally, buccally, and orally in each implant; following the EFP guidelines (European Federation of Periodontology 2018).
Clinical performance - peri-implant health
Time frame: 10 years
During the clinical follow-up appointments, peri-implant health was evaluated by using a periodontal probe. Plaque index (1-3) All parameters were evaluated mesially, distally, buccally, and orally in each implant; following the EFP guidelines (European Federation of Periodontology 2018).
Clinical performance - peri-implant health
Time frame: 10 years
During the clinical follow-up appointments, peri-implant health was evaluated by using a periodontal probe. Bleeding on probing (yes/no) All parameters were evaluated mesially, distally, buccally, and orally in each implant; following the EFP guidelines (European Federation of Periodontology 2018).
Clinical performance - peri-implant health
Time frame: 10 years
During the clinical follow-up appointments, peri-implant health was evaluated by using a periodontal probe. Pus (yes/no) All parameters were evaluated mesially, distally, buccally, and orally in each implant; following the EFP guidelines (European Federation of Periodontology 2018).
Clinical performance - peri-implant health
Time frame: 10 years
During the clinical follow-up appointments, peri-implant health was evaluated by using a periodontal probe. Keratinized mucosa (mm) All parameters were evaluated mesially, distally, buccally, and orally in each implant; following the EFP guidelines (European Federation of Periodontology 2018).
Clinical performance - PIBL, implant-crown fit
Time frame: 10 years
To assess Peri-implant Bone Level (mm), a standardized digital periapical radiograph was taken at the scheduled follow-up visits. An independent examiner performed a radiological linear evaluation (mm) using image analysis software (ImageJ)
Clinical performance - PIBL, implant-crown fit
Time frame: 10 years
To assess implant-crown fit (misfit yes/no), a standardized digital periapical radiograph was taken at the scheduled follow-up visits. An independent examiner performed a radiological linear evaluation (mm) using image analysis software (ImageJ)
Clinical performance
Time frame: 10 years
Patient satisfaction with the implant treatment was evaluated using a 10 cm visual analogue scale (VAS). From 0 (The worst) to 10 (The best).
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 18 Nov 2023.
- 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.
Martin Schimmel, Prof study chair
University of Bern
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, run by University of Bern at 1 site in Switzerland.
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 7 inclusion and 8 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 18 Nov 2023. 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 Switzerland. 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?
Clinical performance - survival (time frame: 10 years). The study lists 12 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 18 Nov 2023.