Peri-implantitisNCT03801187
Surgical Protocol for Peri-implantitis Treatment
A study testing chlorhexidine, Er:YAG laser and Air-Powder in people with Peri-implantitis, run by Università Vita-Salute San Raffaele at 1 site in Italy.
Trial summary
Peri-implant diseases are common post-restorative complications in implant rehabilitations and they occur with an incidence of 12-43%. Based on the available data in literature, the surgical therapy for peri-implantitis is effective in disease resolution. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Peri-implantitis
- What is being tested?
- chlorhexidine, 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
- 45 participants
- Where
- 1 siteItaly
- Study dates
- 2 Jul 2018to 31 Dec 2021
- 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
- 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 with:
- PPD ≥ 5 mm and bone loss ≥ 2 mm (compared to crestal bone levels at the time of placement of the reconstruction)
- PPD ≥6 and bone loss ≥3 (not compared to crestal bone levels at the time of placement of the reconstruction)
- single tooth and bridgework restorations without overhangs
- no evidence of occlusal overload (i.e. occlusal contacts revealed appropriate adjustment),
- treated chronic periodontitis and proper periodontal maintenance care
Show all 9Show fewer
- FMPS < 20%
- non-smoker or light smoking status in smokers (<10 cigarettes per day)
- 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
- hollow implants
- 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.
Italy1 site, 1 recruiting
- Recruiting
Università Vita-Salute San Raffaele
Milan, 20100
Marco Clementini, mclementini@me.com
About this study
Official title: Surgical Protocol for Peri-implantitis in Horizontal Defect With Keratinised Tissue Using Er:YAG Laser or an Air-abrasive Device in Addition to Chlorhexidine: a Randomized Clinical Trial
Peri-implant diseases are common post-restorative complications in implant rehabilitations and they occur with an incidence of 12-43%.
Based on the available data in literature, the surgical therapy for peri-implantitis is effective in disease resolution. Surgical access to peri-implant lesions facilitates the removal of all granulation tissue from the defect area as well as debridement and decontamination of the exposed implant surface defect area.
Different techniques have been used for implant surface decontamination during peri-implant surgery, including mechanical, chemical and laser treatments.
Read the detailed description
Peri-implantitis are defined as inflammatory diseases caused by bacterial biofilm around implant surface characterized by bleeding on probing, probing depth and eventually bone loss; if not successfully treated they may lead to implant loss. Based on the available parameters that have been reported in literature non surgical therapy doesn't seem to be effective on peri-implantitis. Therefore it is recommended to consider advanced therapies such as surgical interventions when non surgical peri-implant therapy fails to achieve significant improvements in clinical parameters.
Numerous approaches have been used for implant surface decontamination during peri-implant surgery, including mechanical, chemical and laser treatments.
Conventional mechanical means don't seem to be effective on peri-implant diseases. In addition, the rough implant surface is a retentive factor for bacterial colonization and therefore makes implant surface difficult to debride.
A treatment protocol that may offer an advantage over traditional mechanical treatment includes the use of laser therapy and air-powder devices. Data have shown that treatments with Er.Yag laser have a bactericidal effect and are safe and effective on implant surfaces. Slightly better clinical results in terms of debridement, probing depth, bleeding on probing and clinical attachment level have been reported by Er:Yag laser treatment compared with traditional non surgical mechanical debridement with titanium curettes and pellet with saline in the surgical treatment of peri-implantitis.
The air abrasive method for debridement has also been used on implant surfaces demonstrating no relevant adverse effect. Until now, powders based on sodium bicarbonate and glycine have been used with pressured air/water. Nowadays a less abrasive method involves the use of erythritol powder.
The aim of the present randomized controlled clinical trial is to assess the efficacy in improving clinical parameters of two further methods of implant decontamination (er:Yag laser or air-abrasive device) after chemical treatment and chemical cleaning during surgical treatment of peri-implantitis in addition to chlorhexidine in horizontal defects with keratinised tissue around implant surfaces.
- Conditions
- Peri-implantitis
- Being tested
- chlorhexidine, Er:YAG laser, Air-Powder
- Keywords
- peri-implantitis, surgical treatment, Er:Yag laser, Air-flow, chlorhexidine
- Medical subject headings
- Peri-Implantitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chlorhexidineProcedure or surgery
Inflammatory tissue, excess cement or plaque deposits will be removed using titanium curettes and the implant surface will be cleaned by copious irrigation with sterile saline and surgical gauze soaked in chlorhexidine.
Er:YAG laserProcedure or surgery
Er.YAg laser treatment will be provided on the implant surface.
Air-PowderProcedure or surgery
An air powder device will be treatment will be provided on the implant surface.
| Study group | Role | What they receive |
|---|---|---|
| Chlorhexidine | Sham comparator | Access flap will be raised to gain access to the implant surface. Inflammatory tissue, excess cement or plaque deposits will be removed using titanium curettes and the implant surface will be cleaned by copious irrigation with sterile saline and surgical gauze soaked in Chlorhexidine. Receives: Procedure: chlorhexidine |
| Er:YAG laser | Experimental | Er: Yag laser treatment will be provided on the implant surface. Receives: Procedure: chlorhexidine; Procedure: Er:YAG laser |
| Air Powder | Active comparator | An Air-Powder treatment will be provided on the implant surface Receives: Procedure: chlorhexidine; 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, 3, 6 and 12 months after treatment
Secondary outcomes (4)
clinical attachment level changes
changes in clinical attachment level, measured from CEJ to the tip of the probe
Measured: baseline, 3, 6 and 12 months after treatment
probing pocket depth changes
changes in probing depth probing, measured from gingival margin to te tip of the probe
Measured: baseline, 3, 6 and 12 months after treatment
mucosal recession changes
changes in mucosal recession, measured from CEJ to gingival margin
Measured: baseline, 3, 6 and 12 months after treatment
bone level changes
changes in bone level at mesial and distal aspect, measured on periapical X-ray
Measured: baseline and 12 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2019
- Study start2 Jul 2018
- Primary completion30 Dec 2020 (estimated)
- Study completion31 Dec 2021 (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.
- 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
- 45 participants (estimated)
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, Prof., Study chair, Università Vita-Salute San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03801187
- Sponsor's protocol ID
- peri-implant surgical-1
- Status last verified
- Nov 2020
- First submitted
- 9 Jan 2019
- Last updated
- 3 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Protocol for Peri-implantitis in Horizontal Defect With Keratinised Tissue Using Er:YAG Laser or an Air-abrasive Device in Addition to Chlorhexidine: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03801187
- Acronym / sponsor ID
- peri-implant surgical-1
- Conditions
- Peri-implantitis
- Keywords
- peri-implantitis, surgical treatment, Er:Yag laser, Air-flow, chlorhexidine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Università Vita-Salute San RaffaeleUniversity, hospital or other
- Study start
- 2 Jul 2018 (actual)
- Primary completion
- 30 Dec 2020 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 11 Jan 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 diseases are common post-restorative complications in implant rehabilitations and they occur with an incidence of 12-43%.
Based on the available data in literature, the surgical therapy for peri-implantitis is effective in disease resolution. Surgical access to peri-implant lesions facilitates the removal of all granulation tissue from the defect area as well as debridement and decontamination of the exposed implant surface defect area.
Different techniques have been used for implant surface decontamination during peri-implant surgery, including mechanical, chemical and laser treatments.
Detailed description
Peri-implantitis are defined as inflammatory diseases caused by bacterial biofilm around implant surface characterized by bleeding on probing, probing depth and eventually bone loss; if not successfully treated they may lead to implant loss. Based on the available parameters that have been reported in literature non surgical therapy doesn't seem to be effective on peri-implantitis. Therefore it is recommended to consider advanced therapies such as surgical interventions when non surgical peri-implant therapy fails to achieve significant improvements in clinical parameters.
Numerous approaches have been used for implant surface decontamination during peri-implant surgery, including mechanical, chemical and laser treatments.
Conventional mechanical means don't seem to be effective on peri-implant diseases. In addition, the rough implant surface is a retentive factor for bacterial colonization and therefore makes implant surface difficult to debride.
A treatment protocol that may offer an advantage over traditional mechanical treatment includes the use of laser therapy and air-powder devices. Data have shown that treatments with Er.Yag laser have a bactericidal effect and are safe and effective on implant surfaces. Slightly better clinical results in terms of debridement, probing depth, bleeding on probing and clinical attachment level have been reported by Er:Yag laser treatment compared with traditional non surgical mechanical debridement with titanium curettes and pellet with saline in the surgical treatment of peri-implantitis.
The air abrasive method for debridement has also been used on implant surfaces demonstrating no relevant adverse effect. Until now, powders based on sodium bicarbonate and glycine have been used with pressured air/water. Nowadays a less abrasive method involves the use of erythritol powder.
The aim of the present randomized controlled clinical trial is to assess the efficacy in improving clinical parameters of two further methods of implant decontamination (er:Yag laser or air-abrasive device) after chemical treatment and chemical cleaning during surgical treatment of peri-implantitis in addition to chlorhexidine in horizontal defects with keratinised tissue around implant surfaces.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Chlorhexidine | Sham comparator | Procedure: chlorhexidineAccess flap will be raised to gain access to the implant surface. Inflammatory tissue, excess cement or plaque deposits will be removed using titanium curettes and the implant surface will be cleaned by copious irrigation with sterile saline and surgical gauze soaked in Chlorhexidine. |
| Er:YAG laser | Experimental | Procedure: chlorhexidine, Procedure: Er:YAG laserEr: Yag laser treatment will be provided on the implant surface. |
| Air Powder | Active comparator | Procedure: chlorhexidine, Procedure: Air-PowderAn Air-Powder treatment will be provided on the implant surface |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- presence of at least one screw-type titanium implant exhibiting bleeding and/or suppuration on probing combined with:
- single tooth and bridgework restorations without overhangs
- no evidence of occlusal overload (i.e. occlusal contacts revealed appropriate adjustment),
- treated chronic periodontitis and proper periodontal maintenance care
- FMPS < 20%
Key exclusion criteria (8 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
- hollow implants
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 |
|---|---|---|
| chlorhexidineInflammatory tissue, excess cement or plaque deposits will be removed using titanium curettes and the implant surface will be cleaned by copious irrigation with sterile saline and surgical gauze soaked in chlorhexidine. | Procedure or surgery | Air Powder, Chlorhexidine, Er:YAG laser |
| Er:YAG laserEr.YAg laser treatment will be provided on the implant surface. | Procedure or surgery | Er:YAG laser |
| Air-PowderAn air powder device will be treatment will be provided on the implant surface. | Procedure or surgery | Air Powder |
Primary outcome
Bleeding on probing changes
Time frame: baseline, 3, 6 and 12 months after treatment
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
clinical attachment level changes
Time frame: baseline, 3, 6 and 12 months after treatment
probing pocket depth changes
Time frame: baseline, 3, 6 and 12 months after treatment
mucosal recession changes
Time frame: baseline, 3, 6 and 12 months after treatment
bone level changes
Time frame: baseline and 12 months after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2020.
- Individual participant dataSharing planned: Undecided
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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, Prof. 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 chlorhexidine, Er:YAG laser and Air-Powder in people with Peri-implantitis, 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 9 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 3 Nov 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marco Clementini (0226432806, mclementini@me.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bleeding on probing changes (time frame: baseline, 3, 6 and 12 months after treatment). 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 Nov 2020.