Peri-implant MucositisNCT05801315
Non-surgical Treatment of Peri-implant Mucositis: FMUD vs FMUD and Air-Flow Master Piezon®
A study testing Glycine powder air polishing and Full mouth ultrasonic debridement in people with Peri-implant Mucositis, run by University of Siena at 1 site in Italy.
Trial summary
The aim of the present study is to evaluate the adjunctive effect of glycine-powder air-polishing (GPAP) to full-mouth ultrasonic debridement (Fm-UD) in the treatment of peri-implant mucositis, and to determine the predictive role of implant and patient-level variables for disease resolution. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Peri-implant Mucositis
- What is being tested?
- Glycine powder air polishing and Full mouth ultrasonic debridement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteItaly
- Study dates
- 1 Mar 2020to 20 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age between 18 and 70 years old;
- presence of one implant loaded at least one year before;
- bleeding on probing and/or suppuration of the peri-implant mucosa;
- pain and/or tenderness of the peri-implant mucosa;
- good general health conditions.
Who cannot join
- radiographic bone loss ≥ 2mm;
- intake of anticoagulants, antiplatelet, antibiotic or cortisone drugs;
- inability to perform oral hygiene maneuvers.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Peri-implant Mucositis: Adjunctive Benefit of Glycine Powder Air Polishing Device to Professional Mechanical Biofilm Removal. A Randomized Parallel Arm Clinical Study
The aim of the present study is to evaluate the adjunctive effect of glycine-powder air-polishing (GPAP) to full-mouth ultrasonic debridement (Fm-UD) in the treatment of peri-implant mucositis, and to determine the predictive role of implant and patient-level variables for disease resolution. Both treatments are described in the literature, but few studies are available on their comparison.
Read the detailed description
52 patients (132 implants) with peri-implant mucositis were included in this randomized parallel arm clinical study. Following baseline variables assessment, participants received Fm-UD. Implants allocated to the test group (n=64) were additionally treated with GPAP. Clinical outcomes were evaluated at 3 and 12 months following intervention. Complete and partial disease resolution were defined as absence of BoP (DR1) or <2 BoP+ sites (DR2), respectively.
- Conditions
- Peri-implant Mucositis
- Being tested
- Glycine powder air polishing, Full mouth ultrasonic debridement
- Keywords
- Peri-implant Mucosits, air polishing device, non-surgical treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glycine powder air polishingDevice
Peri-implant mucositis sites treated with a glycine powder air polishing device (Air-Flow Master Piezon®).
Full mouth ultrasonic debridementDevice
Peri-implant mucositis sites are treated with thin ultrasonic tips.
| Study group | Role | What they receive |
|---|---|---|
| Full mouth ultrasonic debridement plus glycine powder air polishing | Experimental | Plaque and calculus are firstly removed through full mouth ultrasonic debridement (FMUD) in all sites (both dental and implant). After this procedure an air polishing device (Air-flow Master Piezon®) is used as additional therapy to further debride peri-implant trans-mucosal tract. Receives: Device: Glycine powder air polishing; Device: Full mouth ultrasonic debridement |
| Full mouth ultrasonic debridement | Active comparator | Plaque and calculus are removed through full mouth ultrasonic debridement (FMUD) in all sites (both dental and implant). Receives: Device: Full mouth ultrasonic debridement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bleeding on probing
After probing dental and implant sites a dichotomic value (0/1) is assigned for each site. 0: not bleeding site; 1: bleeding site.
Measured: 12 months
Secondary outcomes (1)
Probing pocket depth change
Change in probing pocket depth measured in millimeter through a periodontal probe.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2023
- Study start1 Mar 2020
- Primary completion20 Mar 2023
- Study completion20 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peri-implant MucositisStudies 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
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Siena
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicola Discepoli, University of Siena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05801315
- Sponsor's protocol ID
- MU001
- Status last verified
- Jul 2023
- First submitted
- 4 Mar 2020
- Last updated
- 27 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Nicola D, Isabella R, Carolina C, Baldini N, Raffaele M. Treatment of peri-implant mucositis: Adjunctive effect of glycine powder air polishing to professional mechanical biofilm removal. 12 months randomized clinical study. Clin Implant Dent Relat Res. 2024 Apr;26(2):415-426. doi: 10.1111/cid.13304. Epub 2024 Feb 5.
PubMed 38317375
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Peri-implant Mucositis: Adjunctive Benefit of Glycine Powder Air Polishing Device to Professional Mechanical Biofilm Removal. A Randomized Parallel Arm Clinical Study
- ClinicalTrials.gov ID
- NCT05801315
- Acronym / sponsor ID
- MU001
- Conditions
- Peri-implant Mucositis
- Keywords
- Peri-implant Mucosits, air polishing device, non-surgical treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University of SienaUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 20 Mar 2023 (actual)
- Study completion
- 20 Mar 2023 (actual)
- First posted
- 6 Apr 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.
The aim of the present study is to evaluate the adjunctive effect of glycine-powder air-polishing (GPAP) to full-mouth ultrasonic debridement (Fm-UD) in the treatment of peri-implant mucositis, and to determine the predictive role of implant and patient-level variables for disease resolution. Both treatments are described in the literature, but few studies are available on their comparison.
Detailed description
52 patients (132 implants) with peri-implant mucositis were included in this randomized parallel arm clinical study. Following baseline variables assessment, participants received Fm-UD. Implants allocated to the test group (n=64) were additionally treated with GPAP. Clinical outcomes were evaluated at 3 and 12 months following intervention. Complete and partial disease resolution were defined as absence of BoP (DR1) or <2 BoP+ sites (DR2), respectively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Full mouth ultrasonic debridement plus glycine powder air polishing | Experimental | Device: Glycine powder air polishing, Device: Full mouth ultrasonic debridementPlaque and calculus are firstly removed through full mouth ultrasonic debridement (FMUD) in all sites (both dental and implant). After this procedure an air polishing device (Air-flow Master Piezon®) is used as additional therapy to further debride peri-implant trans-mucosal tract. |
| Full mouth ultrasonic debridement | Active comparator | Device: Full mouth ultrasonic debridementPlaque and calculus are removed through full mouth ultrasonic debridement (FMUD) in all sites (both dental and implant). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age between 18 and 70 years old;
- presence of one implant loaded at least one year before;
- bleeding on probing and/or suppuration of the peri-implant mucosa;
- pain and/or tenderness of the peri-implant mucosa;
- good general health conditions.
Key exclusion criteria (3 listed)
- radiographic bone loss ≥ 2mm;
- intake of anticoagulants, antiplatelet, antibiotic or cortisone drugs;
- inability to perform oral hygiene maneuvers.
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 |
|---|---|---|
| Glycine powder air polishingPeri-implant mucositis sites treated with a glycine powder air polishing device (Air-Flow Master Piezon®). | Device | Full mouth ultrasonic debridement plus glycine powder air polishing |
| Full mouth ultrasonic debridementPeri-implant mucositis sites are treated with thin ultrasonic tips. | Device | Full mouth ultrasonic debridement, Full mouth ultrasonic debridement plus glycine powder air polishing |
Primary outcome
Bleeding on probing
Time frame: 12 months
After probing dental and implant sites a dichotomic value (0/1) is assigned for each site. 0: not bleeding site; 1: bleeding site.
1 secondary outcome
Probing pocket depth change
Time frame: 12 months
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 27 Jul 2023.
- Derived from this study: PubMed 38317375Nicola D, Isabella R, Carolina C, Baldini N, Raffaele M. Treatment of peri-implant mucositis: Adjunctive effect of glycine powder air polishing to professional mechanical biofilm removal. 12 months randomized clinical study. Clin Implant Dent Relat Res. 2024 Apr;26(2):415-426. doi: 10.1111/cid.13304. Epub 2024 Feb 5.
Related trials for Peri-implant Mucositis
RecruitingObservational study
Evaluation of 25(OH)D3 and LL-37 Levels in Periimplant Sulcus Fluid
Peri Implantitis, Peri Implant Mucositis
Recruiting
Home-Use Dual-Light Antibacterial Photodynamic Therapy for Peri-Implant Mucositis in Full-Arch Implant Prostheses
Peri Implant Mucositis, Dental Implant Rehabilitation
Not yet recruiting
Adjunctive Diode Laser Therapy for Peri-Implant Mucositis
Peri-implant Mucositis
Not yet recruitingObservational study
Short Versus Standard Dental Implants: Clinical and Biomarker Outcomes
Peri-Implant Mucositis
RecruitingObservational study
Impact of Smoking on Immune Responses in Peri-implant Health and Disease
Peri-Implant Health, Peri Implant Mucositis
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 Glycine powder air polishing and Full mouth ultrasonic debridement in people with Peri-implant Mucositis, run by University of Siena at 1 site in Italy.
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 5 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: finished, as of the sponsor's last update on 27 Jul 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 Italy. 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?
Bleeding on probing (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05801315, which also lists 1 linked publication.
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 27 Jul 2023.