Peri-implant MucositisNCT03951636
Non Surgical Protocol for Treatment of Mucositis
A study testing Mechanical debridement with curettes, Er:YAG laser and Air Powder in people with Peri-implant Mucositis, run by Università Vita-Salute San Raffaele at 1 site in Italy.
Trial summary
Peri-implant mucositis is an important disease entity as a result of its high prevalence and the lack of a standard mode of therapy. Non-surgical therapy of peri-implant mucositis appears to be partially effective in resolving the disease. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Peri-implant Mucositis
- What is being tested?
- Mechanical debridement with curettes, Er:YAG laser and Air Powder
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteItaly
- Study dates
- 2 Jul 2019to 27 Jul 2022
- 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 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- presence of at least one screw-type titanium implant exhibiting bleeding and/or suppuration on probing combined without progressive radiographic bone loss (compared to crestal bone levels at the time of placement of the reconstruction)or <3mm bone level
- single tooth and bridgework restorations without overhangings
- no evidence of occlusal overload (i.e. occlusal contacts revealed appropriate adjustment)
- implant function time ≥ 1 year
Who cannot join
- Patients with uncontrolled diabetes
- patients with osteoporosis or under bisphosphonate medication,
- pregnant or lactating women,
- patients with a history of radiotherapy to the head and neck region
- patients with incapability to perform basal oral hygiene measures due to physical or mental disorders
- hollow implants
Show all 9Show fewer
- implant mobility
- implants at which no position could be identified where proper probing measurements could be performed;
- previous surgical treatment of the peri-implantitis lesions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Non Surgical Protocol for Treatment of Mucositis Using an Er:YAG Laser or an Air-abrasive Device: a Randomized Clinical Trial
Peri-implant mucositis is an important disease entity as a result of its high prevalence and the lack of a standard mode of therapy.
Non-surgical therapy of peri-implant mucositis appears to be partially effective in resolving the disease. In several cases, however, only limited improvements have been reported in the main clinical parameters (bleeding partial resolution and presence of pocket at follow-up visits) and there is a clear tendency to relapse of the disease.
Read more
In these cases it is therefore recommended to consider adjunctive therapies. Numerous approaches have been used for implant surface decontamination including mechanical, chemical and treatments by means of air-powder or laser.
The aim of the present randomized controlled clinical trial will be to assess the efficacy in improving clinical parameters of two further methods of implant surface decontamination (Er:YAG laser or air-abrasive device) after mechanical cleaning during non surgical treatment of peri-implant mucositis.
Read the detailed description
Peri-implant mucositis, defined as an inflammatory lesion of the surrounding peri-implant tissues without loss of supporting bone, is an important disease entity as a result of its high prevalence and the lack of a standard mode of therapy. Although the current epidemiological data are limited, peri-implant mucositis affects 43% of the subjects.
Numerous approaches have been used for implant surface decontamination, including mechanical, chemical and laser treatments. Using conventional mechanical means, eradication of pathogens on implant surfaces with threads and often with rough surface structures is difficult. Treatment models, such as debridement, effectively used to treat teeth with periodontitis, cannot be used in the same way on rough threaded implant surfaces. The implant rough surface structure also provides the bacteria with ''protected areas'', inaccessible to conventional mechanical removal.
A treatment protocol that may offer an advantage over traditional mechanical treatment includes the use of laser therapy. Data have shown that treatments with Er:YAG lasers have a bactericidal effect. Er:YAG laser treatment can debride the implant surface effectively and safely. Slightly better clinical results in terms of bleeding on probing and clinical attachment level have been reported by Er:YAG laser treatment as compared with traditional non-surgical mechanical debridement with curettes and chlorhexidine.
The air abrasive method for the removal of bacterial plaque on tooth surfaces has also been used in the treatment of mucositis, demonstrating no relevant adverse effects. Until recently, air-polishing devices have used a slurry of water and sodium bicarbonate (NaHCO3) and pressurized air/water. A less abrasive method using an aminoacid glycine has been proven to be effective in removing bacterial biofilm structures in deep periodontal pockets and safe by not causing emphysema. Moreover the use of a glycine-based powder does not seem to cause titanium implant surface changes.
The aim of the present randomized controlled clinical trial will be to assess the efficacy in improving clinical parameters of two further methods of implant surface decontamination (Er:YAG laser or air-abrasive device) after mechanical cleaning during non surgical treatment of mucositis.
- Conditions
- Peri-implant Mucositis
- Being tested
- Mechanical debridement with curettes, Er:YAG laser, Air Powder
- Keywords
- peri-implant mucositis, non surgical therapy, laser, air powder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechanical debridement with curettesProcedure or surgery
mechanical debridement: Inflammatory tissue, excess cement or plaque deposits will be removed using hand instruments
Er:YAG laserProcedure or surgery
mechanical debridement: Inflammatory tissue, excess cement or plaque deposits will be removed using hand instruments. Furthermore, an Er:YAG laser will be used for the implant surface decontamination.
Air PowderProcedure or surgery
mechanical debridement: Inflammatory tissue, excess cement or plaque deposits will be removed using hand instruments. Furthermore, an Air-Powder treatment will be provided on the implant/abutment surface.
| Study group | Role | What they receive |
|---|---|---|
| Mechanical debridement with curettes | Sham comparator | mechanical debridement: Inflammatory tissue, excess cement or plaque deposits will be removed using hand instruments Receives: Procedure: Mechanical debridement with curettes |
| Er:YAG laser | Experimental | Er:YAG laser treatment will be provided on the implant/abutment surface. Receives: Procedure: Er:YAG laser |
| Air Powder | Active comparator | an Air-Powder treatment will be provided on the implant/abutment surface. Receives: Procedure: Air Powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bleeding on probing changes
changes of bleeding on probing, evaluated as present if bleeding will be evident within 30 s after probing, or absent, if no bleeding will be noticed within 30 s after probing
Measured: baseline, 1, 3, 6 months
Secondary outcomes (4)
probing pocket depth changes
changes in probing pocket depth, measured from the mucosal margin to the bottom of the probable pocket
Measured: baseline, 1, 3, 6 months
mucosal recession changes
changes in mucosal recession, measured from the mucosal margin to the restoration margin or implant neck
Measured: baseline, 1, 3, 6 months
clinical attachment level changes
changes in clinical attachment level, measured from the restoration margin or implant neck to the bottom of the probable pocket at six aspects per implant (mesio-vestibular, mid-vestibular, disto-vestibular, mesio-oral, mid-oral, and disto-oral.
Measured: baseline, 1, 3, 6 months
complete disease resolution (percentage)
At the implant level, the level of disease resolution was defined as complete when BoP was = 0 out of six sites per implant
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2019
- Study start2 Jul 2019
- Primary completion16 Jan 2022
- Study completion27 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Università Vita-Salute San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marco Clementini, Università Vita-Salute San Raffaele
- Investigators
- Massimo De Sanctis, Study chair, Università Vita-Salute San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03951636
- Sponsor's protocol ID
- mucositis non surgical
- Status last verified
- Feb 2023
- First submitted
- 14 May 2019
- Last updated
- 3 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non Surgical Protocol for Treatment of Mucositis Using an Er:YAG Laser or an Air-abrasive Device: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03951636
- Acronym / sponsor ID
- mucositis non surgical
- Conditions
- Peri-implant Mucositis
- Keywords
- peri-implant mucositis, non surgical therapy, laser, air powder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Università Vita-Salute San RaffaeleUniversity, hospital or other
- Study start
- 2 Jul 2019 (actual)
- Primary completion
- 16 Jan 2022 (actual)
- Study completion
- 27 Jul 2022 (actual)
- First posted
- 15 May 2019 (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.
Peri-implant mucositis is an important disease entity as a result of its high prevalence and the lack of a standard mode of therapy.
Non-surgical therapy of peri-implant mucositis appears to be partially effective in resolving the disease. In several cases, however, only limited improvements have been reported in the main clinical parameters (bleeding partial resolution and presence of pocket at follow-up visits) and there is a clear tendency to relapse of the disease.
In these cases it is therefore recommended to consider adjunctive therapies. Numerous approaches have been used for implant surface decontamination including mechanical, chemical and treatments by means of air-powder or laser.
The aim of the present randomized controlled clinical trial will be to assess the efficacy in improving clinical parameters of two further methods of implant surface decontamination (Er:YAG laser or air-abrasive device) after mechanical cleaning during non surgical treatment of peri-implant mucositis.
Detailed description
Peri-implant mucositis, defined as an inflammatory lesion of the surrounding peri-implant tissues without loss of supporting bone, is an important disease entity as a result of its high prevalence and the lack of a standard mode of therapy. Although the current epidemiological data are limited, peri-implant mucositis affects 43% of the subjects.
Numerous approaches have been used for implant surface decontamination, including mechanical, chemical and laser treatments. Using conventional mechanical means, eradication of pathogens on implant surfaces with threads and often with rough surface structures is difficult. Treatment models, such as debridement, effectively used to treat teeth with periodontitis, cannot be used in the same way on rough threaded implant surfaces. The implant rough surface structure also provides the bacteria with ''protected areas'', inaccessible to conventional mechanical removal.
A treatment protocol that may offer an advantage over traditional mechanical treatment includes the use of laser therapy. Data have shown that treatments with Er:YAG lasers have a bactericidal effect. Er:YAG laser treatment can debride the implant surface effectively and safely. Slightly better clinical results in terms of bleeding on probing and clinical attachment level have been reported by Er:YAG laser treatment as compared with traditional non-surgical mechanical debridement with curettes and chlorhexidine.
The air abrasive method for the removal of bacterial plaque on tooth surfaces has also been used in the treatment of mucositis, demonstrating no relevant adverse effects. Until recently, air-polishing devices have used a slurry of water and sodium bicarbonate (NaHCO3) and pressurized air/water. A less abrasive method using an aminoacid glycine has been proven to be effective in removing bacterial biofilm structures in deep periodontal pockets and safe by not causing emphysema. Moreover the use of a glycine-based powder does not seem to cause titanium implant surface changes.
The aim of the present randomized controlled clinical trial will be to assess the efficacy in improving clinical parameters of two further methods of implant surface decontamination (Er:YAG laser or air-abrasive device) after mechanical cleaning during non surgical treatment of mucositis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mechanical debridement with curettes | Sham comparator | Procedure: Mechanical debridement with curettesmechanical debridement: Inflammatory tissue, excess cement or plaque deposits will be removed using hand instruments |
| Er:YAG laser | Experimental | Procedure: Er:YAG laserEr:YAG laser treatment will be provided on the implant/abutment surface. |
| Air Powder | Active comparator | Procedure: Air Powderan Air-Powder treatment will be provided on the implant/abutment surface. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- presence of at least one screw-type titanium implant exhibiting bleeding and/or suppuration on probing combined without progressive radiographic bone loss (compared to crestal bone levels at the time of placement of the reconstruction)or <3mm bone level
- single tooth and bridgework restorations without overhangings
- no evidence of occlusal overload (i.e. occlusal contacts revealed appropriate adjustment)
- implant function time ≥ 1 year
Key exclusion criteria (9 listed)
- Patients with uncontrolled diabetes
- patients with osteoporosis or under bisphosphonate medication,
- pregnant or lactating women,
- patients with a history of radiotherapy to the head and neck region
- patients with incapability to perform basal oral hygiene measures due to physical or mental 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 |
|---|---|---|
| Mechanical debridement with curettesmechanical debridement: Inflammatory tissue, excess cement or plaque deposits will be removed using hand instruments | Procedure or surgery | Mechanical debridement with curettes |
| Er:YAG lasermechanical debridement: Inflammatory tissue, excess cement or plaque deposits will be removed using hand instruments. Furthermore, an Er:YAG laser will be used for the implant surface decontamination. | Procedure or surgery | Er:YAG laser |
| Air Powdermechanical debridement: Inflammatory tissue, excess cement or plaque deposits will be removed using hand instruments. Furthermore, an Air-Powder treatment will be provided on the implant/abutment surface. | Procedure or surgery | Air Powder |
Primary outcome
Bleeding on probing changes
Time frame: baseline, 1, 3, 6 months
changes of bleeding on probing, evaluated as present if bleeding will be evident within 30 s after probing, or absent, if no bleeding will be noticed within 30 s after probing
4 secondary outcomes
probing pocket depth changes
Time frame: baseline, 1, 3, 6 months
mucosal recession changes
Time frame: baseline, 1, 3, 6 months
clinical attachment level changes
Time frame: baseline, 1, 3, 6 months
complete disease resolution (percentage)
Time frame: 6 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 3 Mar 2023.
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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.
Massimo De Sanctis study chair
Università Vita-Salute San Raffaele
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mechanical debridement with curettes, Er:YAG laser and Air Powder in people with Peri-implant Mucositis, run by Università Vita-Salute San Raffaele 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 4 inclusion and 9 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 Mar 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. Some participants in this study may receive a placebo. 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 changes (time frame: baseline, 1, 3, 6 months). 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 Mar 2023.