Edentulous Alveolar Ridge AtrophyNCT05638958
Immediate Implants With Customized Abutments
A study testing Immediate post-extractive Implant placement in people with Edentulous Alveolar Ridge Atrophy, run by University Hospital, Geneva at 1 site in Switzerland.
Trial summary
Tooth extraction is followed by marked alterations of the tissue volume. The resorption process of at least the surrounding mucosa can be altered by using immediate implant placement and additional features such as immediate provisional crown, platform switching and grafting the gap between implant and buccal bone… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Edentulous Alveolar Ridge Atrophy
- What is being tested?
- Immediate post-extractive Implant placement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSwitzerland
- Study dates
- 10 Mar 2018to 10 Mar 2023
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient is ≥ 18 years old
- Extraction of single rooted tooth with healthy adjacent teeth (PD<5mm, no BOP)
- Patient must be able to understand the purpose of the study and to sign the consent form
Who cannot join
- Smoking status of more than 10 cigarettes/day
- History of uncontrolled metabolic disorders (e.g. diabetes mellitus)
- History of malignancy, radiotherapy, or chemotherapy
- Pregnant or breast feeding
- History of immunodeficiences
- existence of metabolic bone disease or disease affecting bone healing
- untreated or active periodontitis (BOP and PD>5mm)
- absence or defects of the buccal bone plate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Peri-implant Gap Grafting and Immediate Provisionalization With Customized Healing Abutments on the Stability of Peri-implant Soft Tissues - a Randomized Clinical Trial
Tooth extraction is followed by marked alterations of the tissue volume. The resorption process of at least the surrounding mucosa can be altered by using immediate implant placement and additional features such as immediate provisional crown, platform switching and grafting the gap between implant and buccal bone plate. The support of the gingival margin with a provisional crown led to an increase of buccal gingival tissue.
Teeth scheduled for extraction will be used to study the effect of a customized healing abutment.
Read more
The following groups will be randomly assigned:
Control: A commercially available healing abutment will be screwed on top of the implant and a collagen sponge will be used to protect the graft.
Test: A customized PEEK abutment mimicking the subgingival emergence of the extracted tooth will be screw retained on top of the implant to seal the extraction site.
Read the detailed description
Tooth extraction is followed by marked alterations of the tissue volume. Incorporation of biomaterials into a fresh extraction socket can significantly reduce alveolar resorption but is not able to diminish the biologic process of the buccal bone plate. The resorption process of at least the surrounding mucosa can be altered by using immediate implant placement and additional features such as immediate provisional crown, platform switching and grafting the gap between implant and buccal bone plate. The support of the gingival margin with a provisional crown led to an increase of buccal gingival tissue. Platform switching seems to be a viable option to reduce interproximal bone level alterations and to limit the buccal soft tissue recession. Furthermore, augmenting the defect between the implant and the buccal bone plate has been proven to reduce the resorption process and lead to less shrinkage.
The primary objective is:
- The implant success
The Secondary objectives are:
- The Changes in mid-facial mucosal recession
- The changes in papilla height
- The changes in soft tissue ridge width
- The aesthetic evaluation
- The implant stability
- Conditions
- Edentulous Alveolar Ridge Atrophy
- Being tested
- Immediate post-extractive Implant placement
- Keywords
- immediate implants, immediate provvisional, soft tissue recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate post-extractive Implant placementDevice
Teeth scheduled for extraction will be used to study the effect of a customized healing abutment. All patients should receive prophylactic antibiotic therapy of 2g of amoxicillin (or clindamycin 600mg if allergic to penicillin) 1 hour before the surgery. Implant placed along the lingual/palatal bone plate and the implant platform should be placed at the level of the buccal bone plate. GUIDOR easy-graft CRYSTAL will be used to fill the defect between implant and buccal bone plate, subsequently, a standard healing abutment or a customized healing abutment will be screw-retained on the implants.
| Study group | Role | What they receive |
|---|---|---|
| Test group | Experimental | A customized PEEK abutment mimicking the subgingival emergence of the extraction site will be screw-retained on the implant to seal the extraction site and to support healing of buccal soft tissues. Receives: Device: Immediate post-extractive Implant placement |
| Control group | Active comparator | A commercially available healing abutment will be screwed on top of the implant and a collagen sponge will be used to protect the graft. Receives: Device: Immediate post-extractive Implant placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant success
Evaluated according to the criteria of Albrektsson et al. (1986):
- the implant is immobile when tested clinically
- Radiography does not demonstrate evidence of peri-implant radiolucency
- Bone loss that is less than 0.2 mm annually after the implant's first year of service
- No pain, discomfort or infection
Measured: 1 year of follow up
Peri-implant marginal bone level- Radiographic Measurements
Peri-implant bone level will be assessed based on individual peri-apical x-rays performed at baseline, after implant placement, at the time of final impression at 90 days and after insertion of the definitive crown after 160 days using an individualized impression tray with resin imprints and at 1, 2, 3 years of follow up. The radiographic measurements will be performed by an independent evaluator, who will be unware of the assigned treatment.
Measured: 1 year of follow up
Peri-implant marginal bone level- Radiographic Measurements
Peri-implant bone level will be assessed based on individual peri-apical x-rays performed at baseline, after implant placement, at the time of final impression at 90 days and after insertion of the definitive crown after 160 days using an individualized impression tray with resin imprints and at 1, 2, 3 years of follow up. The radiographic measurements will be performed by an independent evaluator, who will be unware of the assigned treatment.
Measured: 2 years of follow up
Peri-implant marginal bone level- Radiographic Measurements
Peri-implant bone level will be assessed based on individual peri-apical x-rays performed at baseline, after implant placement, at the time of final impression at 90 days and after insertion of the definitive crown after 160 days using an individualized impression tray with resin imprints and at 1, 2, 3 years of follow up. The radiographic measurements will be performed by an independent evaluator, who will be unware of the assigned treatment.
Measured: 3 years of follow up
Implant success
Evaluated according to the criteria of Albrektsson et al. (1986):
- the implant is immobile when tested clinically
- Radiography does not demonstrate evidence of peri-implant radiolucency
- Bone loss that is less than 0.2 mm annually after the implant's first year of service
- No pain, discomfort or infection
Measured: 2 years of follow up
Implant success
Evaluated according to the criteria of Albrektsson et al. (1986):
- the implant is immobile when tested clinically
- Radiography does not demonstrate evidence of peri-implant radiolucency
- Bone loss that is less than 0.2 mm annually after the implant's first year of service
- No pain, discomfort or infection
Measured: 3 years of follow up
Secondary outcomes (17)
Changes in mid-facial mucosal recession
The height of the mid-facial mucosa will be measured using the drilling template at baseline before tooth extraction after implant placement at day 45±5 (wound healing day 160±5 (primary endpoint - impression for final restoration) and at 1, 2, 3 years of follow up. Changes of mid-facial mucosal recession will be drawn by subtracting the post-op measurements from the baseline measurements.
Measured: 1 year of follow up
Changes in mid-facial mucosal recession
The height of the mid-facial mucosa will be measured using the drilling template at baseline before tooth extraction after implant placement at day 45±5 (wound healing day 160±5 (primary endpoint - impression for final restoration) and at 1, 2, 3 years of follow up. Changes of mid-facial mucosal recession will be drawn by subtracting the post-op measurements from the baseline measurements.
Measured: 2 years of follow up
Changes in mid-facial mucosal recession
The height of the mid-facial mucosa will be measured using the drilling template at baseline before tooth extraction after implant placement at day 45±5 (wound healing day 160±5 (primary endpoint - impression for final restoration) and at 1, 2, 3 years of follow up. Changes of mid-facial mucosal recession will be drawn by subtracting the post-op measurements from the baseline measurements.
Measured: 3 years of follow up
Changes in papilla height
Height of the mesial and distal papilla will be assessed by measuring the distance between the incisal edge and the tip of the papilla using a caliper to the nearest 0.5mm before tooth extraction, after implant placement 45±5 during wound healing and at the time of final impression at 90±5 days, at 160±14 days after insertion of the definitive crown and at 1, 2, 3 years of follow up. Papilla height changes will be assessed by subtracting post-op measurements from baseline measurements before tooth extraction or after implant placement.
Measured: 1 year of follow up
Changes in papilla height
Height of the mesial and distal papilla will be assessed by measuring the distance between the incisal edge and the tip of the papilla using a caliper to the nearest 0.5mm before tooth extraction, after implant placement 45±5 during wound healing and at the time of final impression at 90±5 days, at 160±14 days after insertion of the definitive crown and at 1, 2, 3 years of follow up. Papilla height changes will be assessed by subtracting post-op measurements from baseline measurements before tooth extraction or after implant placement.
Measured: 2 years of follow up
Changes in papilla height
Height of the mesial and distal papilla will be assessed by measuring the distance between the incisal edge and the tip of the papilla using a caliper to the nearest 0.5mm before tooth extraction, after implant placement 45±5 during wound healing and at the time of final impression at 90±5 days, at 160±14 days after insertion of the definitive crown and at 1, 2, 3 years of follow up. Papilla height changes will be assessed by subtracting post-op measurements from baseline measurements before tooth extraction or after implant placement.
Measured: 3 years of follow up
Changes in soft tissue ridge width - Volumetric measurements
Digital scans of the implant region will be obtained at baseline before tooth extraction and after implant placement, at day 45±5 during wound healing of final impression at 90 days, at 160 days after insertion of the definitive crown and at 1, 2, 3 years of follow up.
Measured: 1 year of follow up
Changes in soft tissue ridge width - Volumetric measurements
Digital scans of the implant region will be obtained at baseline before tooth extraction and after implant placement, at day 45±5 during wound healing of final impression at 90 days, at 160 days after insertion of the definitive crown and at 1, 2, 3 years of follow up.
Measured: 2 years of follow up
Changes in soft tissue ridge width - Volumetric measurements
Digital scans of the implant region will be obtained at baseline before tooth extraction and after implant placement, at day 45±5 during wound healing of final impression at 90 days, at 160 days after insertion of the definitive crown and at 1, 2, 3 years of follow up.
Measured: 3 years of follow up
Aesthetic evaluation (PES)
Pink esthetic score will be assessed on photographic images the tooth after final restoration and the insertion of the definitive crown. The assessment will be performed by an independent evaluator unaware of the assigned treatment.
Measured: 1 year of follow up
Aesthetic evaluation (PES)
Pink esthetic score will be assessed on photographic images the tooth after final restoration and the insertion of the definitive crown. The assessment will be performed by an independent evaluator unaware of the assigned treatment.
Measured: 2 years of follow up
Aesthetic evaluation (PES)
Pink esthetic score will be assessed on photographic images the tooth after final restoration and the insertion of the definitive crown. The assessment will be performed by an independent evaluator unaware of the assigned treatment.
Measured: 3 years of follow up
Implant stability (ISQ)
Implant stability will be assessed using a resonance frequency measurement device and assessing Implant Stability Quotient (ISQ) scores after implant placement, at the time of final impression at 90 days, at 160 days after insertion of the definitive crown and at 1, 2, 3 years of follow up.
Measured: 90 days after insertion of the definitive crown
Implant stability (ISQ)
Implant stability will be assessed using a resonance frequency measurement device and assessing Implant Stability Quotient (ISQ) scores after implant placement, at the time of final impression at 90 days, at 160 days after insertion of the definitive crown and at 1, 2, 3 years of follow up.
Measured: 160 days after insertion of the definitive crown
Implant stability (ISQ)
Implant stability will be assessed using a resonance frequency measurement device and assessing Implant Stability Quotient (ISQ) scores after implant placement, at the time of final impression at 90 days, at 160 days after insertion of the definitive crown and at 1, 2, 3 years of follow up.
Measured: 1 year of followup
Implant stability (ISQ)
Implant stability will be assessed using a resonance frequency measurement device and assessing Implant Stability Quotient (ISQ) scores after implant placement, at the time of final impression at 90 days, at 160 days after insertion of the definitive crown and at 1, 2, 3 years of follow up.
Measured: 2 years of follow up
Implant stability (ISQ)
Implant stability will be assessed using a resonance frequency measurement device and assessing Implant Stability Quotient (ISQ) scores after implant placement, at the time of final impression at 90 days, at 160 days after insertion of the definitive crown and at 1, 2, 3 years of follow up.
Measured: 3 years of follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2022
- Study start10 Mar 2018
- Primary completion10 Mar 2020
- Study completion10 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Edentulous Alveolar Ridge AtrophyStudies 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
- Test: A customized PEEK abutment mimicking the subgingival emergence of the extracted tooth will be screw retained on top of the implant to seal the extraction site. Control: A commercially available healing abutment will be screwed on top of the implant and a collagen sponge will be used to protect the graft.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexandre Perez, University of Geneva, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05638958
- Sponsor's protocol ID
- AB0005
- Status last verified
- Nov 2022
- First submitted
- 15 Nov 2022
- Last updated
- 6 Dec 2022
- Results posted
- 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 6 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Peri-implant Gap Grafting and Immediate Provisionalization With Customized Healing Abutments on the Stability of Peri-implant Soft Tissues - a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05638958
- Acronym / sponsor ID
- AB0005
- Conditions
- Edentulous Alveolar Ridge Atrophy
- Keywords
- immediate implants, immediate provvisional, soft tissue recession
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- 10 Mar 2018 (actual)
- Primary completion
- 10 Mar 2020 (actual)
- Study completion
- 10 Mar 2023 (estimated)
- First posted
- 6 Dec 2022 (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.
Tooth extraction is followed by marked alterations of the tissue volume. The resorption process of at least the surrounding mucosa can be altered by using immediate implant placement and additional features such as immediate provisional crown, platform switching and grafting the gap between implant and buccal bone plate. The support of the gingival margin with a provisional crown led to an increase of buccal gingival tissue.
Teeth scheduled for extraction will be used to study the effect of a customized healing abutment.
The following groups will be randomly assigned:
Control: A commercially available healing abutment will be screwed on top of the implant and a collagen sponge will be used to protect the graft.
Test: A customized PEEK abutment mimicking the subgingival emergence of the extracted tooth will be screw retained on top of the implant to seal the extraction site.
Detailed description
Tooth extraction is followed by marked alterations of the tissue volume. Incorporation of biomaterials into a fresh extraction socket can significantly reduce alveolar resorption but is not able to diminish the biologic process of the buccal bone plate. The resorption process of at least the surrounding mucosa can be altered by using immediate implant placement and additional features such as immediate provisional crown, platform switching and grafting the gap between implant and buccal bone plate. The support of the gingival margin with a provisional crown led to an increase of buccal gingival tissue. Platform switching seems to be a viable option to reduce interproximal bone level alterations and to limit the buccal soft tissue recession. Furthermore, augmenting the defect between the implant and the buccal bone plate has been proven to reduce the resorption process and lead to less shrinkage.
The primary objective is:
- The implant success
The Secondary objectives are:
- The Changes in mid-facial mucosal recession
- The changes in papilla height
- The changes in soft tissue ridge width
- The aesthetic evaluation
- The implant stability
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Test: A customized PEEK abutment mimicking the subgingival emergence of the extracted tooth will be screw retained on top of the implant to seal the extraction site. Control: A commercially available healing abutment will be screwed on top of the implant and a collagen sponge will be used to protect the graft.
| Arm | Type | Receives |
|---|---|---|
| Test group | Experimental | Device: Immediate post-extractive Implant placementA customized PEEK abutment mimicking the subgingival emergence of the extraction site will be screw-retained on the implant to seal the extraction site and to support healing of buccal soft tissues. |
| Control group | Active comparator | Device: Immediate post-extractive Implant placementA commercially available healing abutment will be screwed on top of the implant and a collagen sponge will be used to protect the graft. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- The patient is ≥ 18 years old
- Extraction of single rooted tooth with healthy adjacent teeth (PD<5mm, no BOP)
- Patient must be able to understand the purpose of the study and to sign the consent form
Key exclusion criteria (8 listed)
- Smoking status of more than 10 cigarettes/day
- History of uncontrolled metabolic disorders (e.g. diabetes mellitus)
- History of malignancy, radiotherapy, or chemotherapy
- Pregnant or breast feeding
- History of immunodeficiences
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 |
|---|---|---|
| Immediate post-extractive Implant placementTeeth scheduled for extraction will be used to study the effect of a customized healing abutment. All patients should receive prophylactic antibiotic therapy of 2g of amoxicillin (or clindamycin 600mg if allergic to penicillin) 1 hour before the surgery. Implant placed along the lingual/palatal bone plate and the implant platform should be placed at the level of the buccal bone plate. GUIDOR easy-graft CRYSTAL will be used to fill the defect between implant and buccal bone plate, subsequently, a standard healing abutment or a customized healing abutment will be screw-retained on the implants. | Device | Control group, Test group |
Primary outcome
Implant success
Time frame: 1 year of follow up
Evaluated according to the criteria of Albrektsson et al. (1986): * the implant is immobile when tested clinically * Radiography does not demonstrate evidence of peri-implant radiolucency * Bone loss that is less than 0.2 mm annually after the implant's first year of service * No pain, discomfort or infection
Peri-implant marginal bone level- Radiographic Measurements
Time frame: 1 year of follow up
Peri-implant bone level will be assessed based on individual peri-apical x-rays performed at baseline, after implant placement, at the time of final impression at 90 days and after insertion of the definitive crown after 160 days using an individualized impression tray with resin imprints and at 1, 2, 3 years of follow up. The radiographic measurements will be performed by an independent evaluator, who will be unware of the assigned treatment.
Peri-implant marginal bone level- Radiographic Measurements
Time frame: 2 years of follow up
Peri-implant bone level will be assessed based on individual peri-apical x-rays performed at baseline, after implant placement, at the time of final impression at 90 days and after insertion of the definitive crown after 160 days using an individualized impression tray with resin imprints and at 1, 2, 3 years of follow up. The radiographic measurements will be performed by an independent evaluator, who will be unware of the assigned treatment.
Peri-implant marginal bone level- Radiographic Measurements
Time frame: 3 years of follow up
Peri-implant bone level will be assessed based on individual peri-apical x-rays performed at baseline, after implant placement, at the time of final impression at 90 days and after insertion of the definitive crown after 160 days using an individualized impression tray with resin imprints and at 1, 2, 3 years of follow up. The radiographic measurements will be performed by an independent evaluator, who will be unware of the assigned treatment.
Implant success
Time frame: 2 years of follow up
Evaluated according to the criteria of Albrektsson et al. (1986): * the implant is immobile when tested clinically * Radiography does not demonstrate evidence of peri-implant radiolucency * Bone loss that is less than 0.2 mm annually after the implant's first year of service * No pain, discomfort or infection
Implant success
Time frame: 3 years of follow up
Evaluated according to the criteria of Albrektsson et al. (1986): * the implant is immobile when tested clinically * Radiography does not demonstrate evidence of peri-implant radiolucency * Bone loss that is less than 0.2 mm annually after the implant's first year of service * No pain, discomfort or infection
17 secondary outcomes
Changes in mid-facial mucosal recession
Time frame: 1 year of follow up
Changes in mid-facial mucosal recession
Time frame: 2 years of follow up
Changes in mid-facial mucosal recession
Time frame: 3 years of follow up
Changes in papilla height
Time frame: 1 year of follow up
Changes in papilla height
Time frame: 2 years of follow up
Changes in papilla height
Time frame: 3 years of follow up
Changes in soft tissue ridge width - Volumetric measurements
Time frame: 1 year of follow up
Changes in soft tissue ridge width - Volumetric measurements
Time frame: 2 years of follow up
Changes in soft tissue ridge width - Volumetric measurements
Time frame: 3 years of follow up
Aesthetic evaluation (PES)
Time frame: 1 year of follow up
Aesthetic evaluation (PES)
Time frame: 2 years of follow up
Aesthetic evaluation (PES)
Time frame: 3 years of follow up
Implant stability (ISQ)
Time frame: 90 days after insertion of the definitive crown
Implant stability (ISQ)
Time frame: 160 days after insertion of the definitive crown
Implant stability (ISQ)
Time frame: 1 year of followup
Implant stability (ISQ)
Time frame: 2 years of follow up
Implant stability (ISQ)
Time frame: 3 years of follow up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2022.
- Individual participant dataSharing planned: No
Related trials for Edentulous Alveolar Ridge Atrophy
Active, not recruiting
Osseodensification for Narrow Alveolar Ridge Expansion
Osseodensification, Bone Expansion
Recruiting
Crestal Bone Loss Around Narrow Diameter Implants Versus Standard Diameter Implants With Bone Augmentation in Horizontally Deficient Posterior Mandibular Sites.
Horizontal Atrophy of Edentulous Alveolar Ridge
Recruiting
Freeze-dried Bone Allograft vs Autologous Bone Blocks in the Lateral Augmentation of the Jaws
Edentulous Alveolar Ridge, Edentulous Alveolar Ridge Atrophy
Not yet recruitingObservational study
Multicentric Prospective Observational Study of Neodent Implantable Devices of Helix Short System
Edentulism, Dental Implant
Recruiting
Morphological Characteristics of Anterior Maxillary Bone and Dynamic Navigation in Full-Arch Implant Placement
Atrophy of Edentulous Maxillary Alveolar Ridge, Alveolar Bone Atrophy
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immediate post-extractive Implant placement in people with Edentulous Alveolar Ridge Atrophy, run by University Hospital, Geneva 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 3 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: status not confirmed, as of the sponsor's last update on 6 Dec 2022. 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?
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?
Implant success (time frame: 1 year of follow up). The study lists 6 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 6 Dec 2022.