Peri-ImplantitisNCT04847648
Air-polishing in the Treatment of Peri-implantitis
A study testing Air-polishing and Mechanical decontamination in people with Peri-Implantitis, run by Göteborg University at 1 site in Sweden.
Trial summary
The aim of the present study is to evaluate the potential benefit of the adjunctive use of an air-polishing device in the non-surgical treatment of peri-implantitis as compared to mechanical infection control alone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peri-Implantitis
- What is being tested?
- Air-polishing and Mechanical decontamination
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSweden
- Study dates
- 14 Oct 2021to 1 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Probing pocket depth of ≥6 mm
- Bleeding and/or suppuration on probing at ≥3 aspects per implant
- Documented radiographic bone loss of ≥2 mm.
Who cannot join
- Implants with bone loss ≥80% of implant length will not be considered.
- No medical conditions prohibiting non-surgical/surgical treatment of peri-implantitis
- Implant(s) in function ≥1 year
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site
Department of Periodontology, Institute of Odontology
Gothenburg, 40530
About this study
Official title: Air-polishing in the Treatment of Peri-implantitis - a Randomized Controlled Trial
The aim of the present study is to evaluate the potential benefit of the adjunctive use of an air-polishing device in the non-surgical treatment of peri-implantitis as compared to mechanical infection control alone. Following establishment of adequate patient-performed infection control, 80 patients diagnosed with moderate/severe peri-implantitis at ≥1 implant will be randomized to one of two groups. Non-surgical will be carried out by experienced operators in three clinical centers and the mechanical instrumentation (control group) will be supplemented by the use of air-polishing with erythritol powder (AirFlow Master, EMS, Nyon, Switzerland) in the test group. The primary outcome assessed is "pocket closure" (ie probing pocket depth ≤5 mm \& absence of profuse bleeding on probing) after 6 months. Secondary outcomes include changes of clinical signs of soft tissue inflammation, adverse events and patient-reported outcome measures. Outcomes of non-surgical therapy will be evaluated at 3 and 6 months. Sites with remaining pathology at 6 months will be subjected to surgical therapy. Patients are then provided with personalized maintenance care and followed up to a 5-year evaluation.
Read the detailed description
The project will be conducted as a two-armed randomized controlled clinical trial of 5-year duration in three clinical centers. 80 systemically healthy patients diagnosed with moderate/severe peri-implantitis at ≥1 implant will be enrolled.
Upon enrolment, all patients will receive instructions in oral hygiene measures until adequate plaque control has been established (Plaque Index ≤20%). If required, supraconstructions will be adjusted to facilitate adequate oral hygiene measures. Thereafter, study participants will be randomized into two groups, stratified for smoking (yes/no) and number of implants in need of treatment (single/multiple).
The control group will be subjected to professionally administered non-surgical, mechanical infection control including the use of hand instruments and polishing cups aiming at the removal of all supra-mucosal soft and hard deposits from the target sites. In the test group the aforementioned treatment will be supplemented by the use of an air-polishing device (AirFlow Master, EMS, Nyon, Switzerland) with a specially designed nozzle for sub-mucosal application (PerioFlow Handpiece, EMS, Nyon, Switzerland). Following local anesthesia, the instrument will be used sub-mucosally at all aspects (ie mesial, distal, buccal, lingual) of the affected implant(s) at a power setting reduced to 60% and with a erythritol powder (14 mikrometer, AirFlow Plus Powder, EMS, Nyon, Switzerland). The handpiece will be guided in a circular motion in a corono-apical direction not in contact with the implant surface. Instrumentation time will be limited to 5 seconds at each aspect. Implant-supported supraconstructions will not be removed for the non-surgical treatment. Patients are recalled two weeks later for assessment of patient-experienced outcomes, professional supramucosal cleaning and reinforcement of oral hygiene.
Peri-implant soft tissues will be evaluated at three months. Implant sites with remaining signs of pathology (PPD ≥6 mm and presence of BOP at ≥3 aspects per implant will be subjected to re-treatment according to the initial allocation. The clinical evaluation will be repeated at 6 months. In case of residual signs of pathology, affected sites will be subjected to surgical therapy of peri-implantitis within the subsequent 4 weeks. Full thickness flaps will be elevated and inflamed tissues will be removed. Mineralized deposits on the implant surfaces will be removed with titanium-coated curettes. Surface decontamination will be performed using a rotating titanium brush under irrigation with saline. No bone recontouring of bony walls is intended. Flaps will be sutured to the level of the bone and sutures will be removed after 2 weeks. Implant-supported supraconstructions will be removed for the surgical intervention, if possible.
Maintenance therapy will be provided at 9 and 12 months and based on individual needs during the subsequent follow-up. A renewed evaluation will be performed at 12 and 18 months. Long-term assessments will be carried out annually from years 3 to 5. Should any implant site present with signs of disease progression (increase of PPD >2 mm and additional bone loss >1 mm compared to baseline) at any of the follow-up examinations, the implant will be exited from the study and appropriate additional therapy will be provided.
- Conditions
- Peri-Implantitis
- Being tested
- Air-polishing, Mechanical decontamination
- Keywords
- Non-surgical therapy, Surgical therapy, Air abrasives, Air polishing
- Medical subject headings
- Peri-Implantitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Air-polishingProcedure or surgery
Air-polishing with erythritol powder during non-surgical therapy (at baseline, 5 seconds per surface, and, if necessary, at 3 months).
Mechanical decontaminationProcedure or surgery
Mechanical instrumentation of implant surfaces during non-surgical therapy (at baseline and, if necesarry at 3 months) including the use of hand instruments and polishing cups aiming at the removal of all soft and hard deposits from the target implant.
| Study group | Role | What they receive |
|---|---|---|
| Control - Mechanical instrumentation of implant surface | Active comparator | The control group will be subjected to non-surgical decontamination including the use of hand instruments and polishing cups aiming at the removal of all supra-mucosal soft and hard deposits from the implant surfaces. Receives: Procedure: Mechanical decontamination |
| Test - Mechanical instrumentation and air-polishing of implant surface | Experimental | In the test group the mechanical instrumentation will be supplemented by the use of an air-polishing device during non-surgical therapy. Receives: Procedure: Air-polishing; Procedure: Mechanical decontamination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants/implants displaying pocket closure
Pocket closure: Probing pocket depth of ≤5 mm and absence of bleeding on probing at ≥3 aspects per implant and absence of suppuration on probing
Measured: 3 months
Proportion of participants/implants displaying pocket closure
Pocket closure: Probing pocket depth of ≤5 mm and absence of bleeding on probing at ≥3 aspects per implant and absence of suppuration on probing
Measured: 6 months
Proportion of participants/implants displaying pocket closure
Pocket closure: Probing pocket depth of ≤5 mm and absence of bleeding on probing at ≥3 aspects per implant and absence of suppuration on probing
Measured: 18 months
Patient satisfaction assessed by visual analogue scale
Patient satisfaction as assessed on a 100 mm VAS
Measured: 3 months
Patient satisfaction assessed by visual analogue scale
Patient satisfaction as assessed on a 100 mm VAS
Measured: 6 months
Patient satisfaction assessed by visual analogue scale
Patient satisfaction as assessed on a 100 mm VAS
Measured: 18 months
Secondary outcomes (30)
Changes in probing pocket depth
Reductions in PPD relative to baseline
Measured: 3 months
Changes in probing pocket depth
Reductions in PPD relative to baseline
Measured: 6 months
Changes in probing pocket depth
Reductions in PPD relative to baseline
Measured: 18 months
Changes in probing pocket depth
Reductions in PPD relative to baseline
Measured: 3 years
Changes in probing pocket depth
Reductions in PPD relative to baseline
Measured: 4 years
Changes in probing pocket depth
Reductions in PPD relative to baseline
Measured: 5 years
Changes in bleeding on probing
Reductions in BOP relative to baseline
Measured: 3 months
Changes in bleeding on probing
Reductions in BOP relative to baseline
Measured: 6 months
Changes in bleeding on probing
Reductions in BOP relative to baseline
Measured: 18 months
Changes in bleeding on probing
Reductions in BOP relative to baseline
Measured: 3 years
Changes in bleeding on probing
Reductions in BOP relative to baseline
Measured: 4 years
Changes in bleeding on probing
Reductions in BOP relative to baseline
Measured: 5 years
Changes in marginal soft soft tissue levels
Changes in marginal soft soft tissue levels relative to baseline
Measured: 3 months
Changes in marginal soft soft tissue levels
Changes in marginal soft soft tissue levels relative to baseline
Measured: 6 months
Changes in marginal soft soft tissue levels
Changes in marginal soft soft tissue levels relative to baseline
Measured: 18 months
Changes in marginal soft soft tissue levels
Changes in marginal soft soft tissue levels relative to baseline
Measured: 3 years
Changes in marginal soft soft tissue levels
Changes in marginal soft soft tissue levels relative to baseline
Measured: 4 years
Changes in marginal soft soft tissue levels
Changes in marginal soft soft tissue levels relative to baseline
Measured: 5 years
Changes in radiographic bone levels
Changes in radiographic bone levels relative to baseline
Measured: 6 months
Changes in radiographic bone levels
Changes in radiographic bone levels relative to baseline
Measured: 18 months
Changes in radiographic bone levels
Changes in radiographic bone levels relative to baseline
Measured: 3 years
Changes in radiographic bone levels
Changes in radiographic bone levels relative to baseline
Measured: 5 years
Rate of adverse events
Emphysema
Measured: 3 months
Rate of adverse events
Emphysema
Measured: 6 months
Rate of adverse events
Emphysema
Measured: 18 months
Patient discomfort as expressed on a visual analogue scale
Patient discomfort 2 weeks after non-surgical treatment as expressed on a 100 mm VAS
Measured: 3.5 months
Patient discomfort as expressed on a visual analogue scale
Patient discomfort 2 weeks after surgical treatment as expressed on a 100 mm VAS
Measured: 6.5 months
Esthetic appreciation as expressed on a visual analogue scale
Esthetic appreciation as expressed on a 100 mm VAS
Measured: 3 months
Esthetic appreciation as expressed on a visual analogue scale
Esthetic appreciation as expressed on a 100 mm VAS
Measured: 6 months
Esthetic appreciation as expressed on a visual analogue scale
Esthetic appreciation as expressed on a 100 mm VAS
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2021
- Study start14 Oct 2021
- Primary completion15 Dec 2026 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peri-ImplantitisStudies of the same condition, open and under way.
- More trials run by Göteborg UniversityThe sponsor's other registered studies.
- 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 project will be conducted as a two-armed randomized controlled clinical trial of 5-year duration in three clinical centers.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jan Derks, Göteborg University
- Investigators
- Kostas Bougas, PhD, Study director, Göteborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04847648
- Sponsor's protocol ID
- 2021-00169
- Status last verified
- Sep 2026
- First submitted
- 7 Apr 2021
- Last updated
- 9 Sep 2026
- 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 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Air-polishing in the Treatment of Peri-implantitis - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04847648
- Acronym / sponsor ID
- 2021-00169
- Conditions
- Peri-Implantitis
- Keywords
- Non-surgical therapy, Surgical therapy, Air abrasives, Air polishing
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Study start
- 14 Oct 2021 (actual)
- Primary completion
- 15 Dec 2026 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 19 Apr 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 aim of the present study is to evaluate the potential benefit of the adjunctive use of an air-polishing device in the non-surgical treatment of peri-implantitis as compared to mechanical infection control alone. Following establishment of adequate patient-performed infection control, 80 patients diagnosed with moderate/severe peri-implantitis at ≥1 implant will be randomized to one of two groups. Non-surgical will be carried out by experienced operators in three clinical centers and the mechanical instrumentation (control group) will be supplemented by the use of air-polishing with erythritol powder (AirFlow Master, EMS, Nyon, Switzerland) in the test group. The primary outcome assessed is "pocket closure" (ie probing pocket depth ≤5 mm \& absence of profuse bleeding on probing) after 6 months. Secondary outcomes include changes of clinical signs of soft tissue inflammation, adverse events and patient-reported outcome measures. Outcomes of non-surgical therapy will be evaluated at 3 and 6 months. Sites with remaining pathology at 6 months will be subjected to surgical therapy. Patients are then provided with personalized maintenance care and followed up to a 5-year evaluation.
Detailed description
The project will be conducted as a two-armed randomized controlled clinical trial of 5-year duration in three clinical centers. 80 systemically healthy patients diagnosed with moderate/severe peri-implantitis at ≥1 implant will be enrolled.
Upon enrolment, all patients will receive instructions in oral hygiene measures until adequate plaque control has been established (Plaque Index ≤20%). If required, supraconstructions will be adjusted to facilitate adequate oral hygiene measures. Thereafter, study participants will be randomized into two groups, stratified for smoking (yes/no) and number of implants in need of treatment (single/multiple).
The control group will be subjected to professionally administered non-surgical, mechanical infection control including the use of hand instruments and polishing cups aiming at the removal of all supra-mucosal soft and hard deposits from the target sites. In the test group the aforementioned treatment will be supplemented by the use of an air-polishing device (AirFlow Master, EMS, Nyon, Switzerland) with a specially designed nozzle for sub-mucosal application (PerioFlow Handpiece, EMS, Nyon, Switzerland). Following local anesthesia, the instrument will be used sub-mucosally at all aspects (ie mesial, distal, buccal, lingual) of the affected implant(s) at a power setting reduced to 60% and with a erythritol powder (14 mikrometer, AirFlow Plus Powder, EMS, Nyon, Switzerland). The handpiece will be guided in a circular motion in a corono-apical direction not in contact with the implant surface. Instrumentation time will be limited to 5 seconds at each aspect. Implant-supported supraconstructions will not be removed for the non-surgical treatment. Patients are recalled two weeks later for assessment of patient-experienced outcomes, professional supramucosal cleaning and reinforcement of oral hygiene.
Peri-implant soft tissues will be evaluated at three months. Implant sites with remaining signs of pathology (PPD ≥6 mm and presence of BOP at ≥3 aspects per implant will be subjected to re-treatment according to the initial allocation. The clinical evaluation will be repeated at 6 months. In case of residual signs of pathology, affected sites will be subjected to surgical therapy of peri-implantitis within the subsequent 4 weeks. Full thickness flaps will be elevated and inflamed tissues will be removed. Mineralized deposits on the implant surfaces will be removed with titanium-coated curettes. Surface decontamination will be performed using a rotating titanium brush under irrigation with saline. No bone recontouring of bony walls is intended. Flaps will be sutured to the level of the bone and sutures will be removed after 2 weeks. Implant-supported supraconstructions will be removed for the surgical intervention, if possible.
Maintenance therapy will be provided at 9 and 12 months and based on individual needs during the subsequent follow-up. A renewed evaluation will be performed at 12 and 18 months. Long-term assessments will be carried out annually from years 3 to 5. Should any implant site present with signs of disease progression (increase of PPD >2 mm and additional bone loss >1 mm compared to baseline) at any of the follow-up examinations, the implant will be exited from the study and appropriate additional therapy will be provided.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The project will be conducted as a two-armed randomized controlled clinical trial of 5-year duration in three clinical centers.
| Arm | Type | Receives |
|---|---|---|
| Control - Mechanical instrumentation of implant surface | Active comparator | Procedure: Mechanical decontaminationThe control group will be subjected to non-surgical decontamination including the use of hand instruments and polishing cups aiming at the removal of all supra-mucosal soft and hard deposits from the implant surfaces. |
| Test - Mechanical instrumentation and air-polishing of implant surface | Experimental | Procedure: Air-polishing, Procedure: Mechanical decontaminationIn the test group the mechanical instrumentation will be supplemented by the use of an air-polishing device during non-surgical therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Probing pocket depth of ≥6 mm
- Bleeding and/or suppuration on probing at ≥3 aspects per implant
- Documented radiographic bone loss of ≥2 mm.
Key exclusion criteria (3 listed)
- Implants with bone loss ≥80% of implant length will not be considered.
- No medical conditions prohibiting non-surgical/surgical treatment of peri-implantitis
- Implant(s) in function ≥1 year
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 |
|---|---|---|
| Air-polishingAir-polishing with erythritol powder during non-surgical therapy (at baseline, 5 seconds per surface, and, if necessary, at 3 months). | Procedure or surgery | Test - Mechanical instrumentation and air-polishing of implant surface |
| Mechanical decontaminationMechanical instrumentation of implant surfaces during non-surgical therapy (at baseline and, if necesarry at 3 months) including the use of hand instruments and polishing cups aiming at the removal of all soft and hard deposits from the target implant. | Procedure or surgery | Control - Mechanical instrumentation of implant surface, Test - Mechanical instrumentation and air-polishing of implant surface |
Primary outcome
Proportion of participants/implants displaying pocket closure
Time frame: 3 months
Pocket closure: Probing pocket depth of ≤5 mm and absence of bleeding on probing at ≥3 aspects per implant and absence of suppuration on probing
Proportion of participants/implants displaying pocket closure
Time frame: 6 months
Pocket closure: Probing pocket depth of ≤5 mm and absence of bleeding on probing at ≥3 aspects per implant and absence of suppuration on probing
Proportion of participants/implants displaying pocket closure
Time frame: 18 months
Pocket closure: Probing pocket depth of ≤5 mm and absence of bleeding on probing at ≥3 aspects per implant and absence of suppuration on probing
Patient satisfaction assessed by visual analogue scale
Time frame: 3 months
Patient satisfaction as assessed on a 100 mm VAS
Patient satisfaction assessed by visual analogue scale
Time frame: 6 months
Patient satisfaction as assessed on a 100 mm VAS
Patient satisfaction assessed by visual analogue scale
Time frame: 18 months
Patient satisfaction as assessed on a 100 mm VAS
30 secondary outcomes
Changes in probing pocket depth
Time frame: 3 months
Changes in probing pocket depth
Time frame: 6 months
Changes in probing pocket depth
Time frame: 18 months
Changes in probing pocket depth
Time frame: 3 years
Changes in probing pocket depth
Time frame: 4 years
Changes in probing pocket depth
Time frame: 5 years
Changes in bleeding on probing
Time frame: 3 months
Changes in bleeding on probing
Time frame: 6 months
Changes in bleeding on probing
Time frame: 18 months
Changes in bleeding on probing
Time frame: 3 years
Changes in bleeding on probing
Time frame: 4 years
Changes in bleeding on probing
Time frame: 5 years
Changes in marginal soft soft tissue levels
Time frame: 3 months
Changes in marginal soft soft tissue levels
Time frame: 6 months
Changes in marginal soft soft tissue levels
Time frame: 18 months
Changes in marginal soft soft tissue levels
Time frame: 3 years
Changes in marginal soft soft tissue levels
Time frame: 4 years
Changes in marginal soft soft tissue levels
Time frame: 5 years
Changes in radiographic bone levels
Time frame: 6 months
Changes in radiographic bone levels
Time frame: 18 months
Changes in radiographic bone levels
Time frame: 3 years
Changes in radiographic bone levels
Time frame: 5 years
Rate of adverse events
Time frame: 3 months
Rate of adverse events
Time frame: 6 months
Rate of adverse events
Time frame: 18 months
Patient discomfort as expressed on a visual analogue scale
Time frame: 3.5 months
Patient discomfort as expressed on a visual analogue scale
Time frame: 6.5 months
Esthetic appreciation as expressed on a visual analogue scale
Time frame: 3 months
Esthetic appreciation as expressed on a visual analogue scale
Time frame: 6 months
Esthetic appreciation as expressed on a visual analogue scale
Time frame: 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Peri-Implantitis
Not yet recruiting
Effect of Customized Versus Stock Healing Abutments on Peri-Implant Soft Tissue
Peri-Implantitis
RecruitingObservational study
Evaluation of 25(OH)D3 and LL-37 Levels in Periimplant Sulcus Fluid
Peri Implantitis, Peri Implant Mucositis
Not yet recruitingObservational study
Diagnostic Accuracy of Large Language Models for Peri-Implant Marginal Bone Loss on Panoramic Radiographs
Peri-implantitis, Alveolar Bone Loss
RecruitingObservational study
Access to Probing and Peri-implant Diseases
Peri-implantitis, Peri-implant Bone Loss
Not yet recruitingObservational study
ATR-FTIR and Raman Spectroscopy of Peri-Implant Crevicular Fluid in Peri-Implantitis
Peri-Implantitis
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.
Kostas Bougas, PhD study director
Göteborg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Air-polishing and Mechanical decontamination in people with Peri-Implantitis, run by Göteborg University at 1 site in Sweden.
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 3 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: enrolling by invitation, as of the sponsor's last update on 9 Sep 2026. 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 Sweden. 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?
This study is still under way. Results are not available in the source record yet.
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?
Proportion of participants/implants displaying pocket closure (time frame: 3 months). 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 9 Sep 2026.