Peri-ImplantitisNCT04565886
Non-surgical Mechanical Therapy of Peri-implantitis With or Without Adjunctive Diode Laser Application
A study testing Diode laser application in people with Peri-Implantitis, run by University of Bern at 1 site in Switzerland.
Trial summary
Peri-implantitis is a pathological condition occurring in tissues around dental implants, characterized by inflammation in the peri-implant connective tissue and progressive loss of supporting bone. 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?
- Diode laser application
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Dec 2019to 1 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- systemically healthy patients enrolled in regular supportive periodontal therapy (SPT)
- Tissue level (TL) implants with an SLA surface supporting single-unit crowns (SUCs) or fixed dental prostheses (FDPs)
- Pocket Probing Depth (PPD) > 5 mm
- Presence of BoP and /or SU
- Radiographic evidence of crestal bone loss ≤ 2mm based on periapical radiographs after delivery of the final restoration
- Cleansable cemented or screw-retained restoration
- Presence of at least 2 mm of keratinized and attached mucosa (KM)
- Signed informed consent
Who cannot join
- Systemic diseases that could interfere with the treatment outcome (e.g. uncontrolled diabetes mellitus, chemotherapy, etc.)
- Previous peri-implantitis treatment
- Full-Mouth Plaque Score (FMPS) > 25%
- Full-Mouth Bleeding Score (FMBS) > 25%
- Cigarette smoking > 10 cig./day
- Removable implant-supported restorations
- Implant mobility
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Periodontology, University of Bern
Bern, 3010
About this study
Official title: Clinical and Radiographic Outcomes Following Non-surgical Mechanical Therapy of Peri-implantitis With or Without Adjunctive Diode Laser Application: A 12-month Double-blinded Randomized Clinical Trial
Peri-implantitis is a pathological condition occurring in tissues around dental implants, characterized by inflammation in the peri-implant connective tissue and progressive loss of supporting bone. The goals of peri-implantitis treatment is the resolution of peri-implant soft tissue inflammation and stabilization of the bony attachment (e.g., the level of osseointegration). For this decontamination of the implant surface is mandatory. In order to increase implant surface decontamination, several adjunctive tools have been proposed and investigated both in pre-clinical and clinical studies such as the use of photodynamic therapy and lasers. So far, no data are available to clearly demonstrate the efficacy of the adjunctive use of a diode laser in the non-surgical treatment of peri-implantitis. Therefore, the aim of the present randomized controlled trial (RCT) is to investigate the adjunctive effect of the application of a diode laser to treat peri-implantitis lesions by means of a non-surgical approach. A total of 30 patients is randomly allocated to two groups. The test group receives 3 x nonsurgical mechanical treatment with diode laser application whereas the control group receives the same treatment with sham laser application. The primary outcome is the peri-implant pocket probing depth at 12 months.
Read the detailed description
Peri-implantitis is a pathological condition occurring in tissues around dental implants, characterized by inflammation in the peri-implant connective tissue and progressive loss of supporting bone. Peri-implantitis is a disease with increasing incidence that, if left untreated, leads to implant loss. The etiological factors of peri-implant infections are similar to those involved in periodontal diseases. Consequently, the goals of peri-implantitis treatment must be the resolution of peri-implant soft tissue inflammation and stabilization of the bony attachment (e.g., the level of osseointegration). This can only be achieved under the condition that the majority of bacterial biofilms and hard deposits are eliminated on the implant surface to create a biologically acceptable surface conducive to wound healing. Decontamination of the implant surface is mandatory to resolve the inflammatory process and to establish healthy peri-implant tissues. To increase implant surface decontamination, several adjunctive tools have been proposed and investigated both in pre-clinical and clinical studies such as the use of photodynamic therapy and lasers. So far, no data are available to clearly demonstrate the efficacy of the adjunctive use of a diode laser in the non-surgical treatment of peri-implantitis. Therefore, the aim of the present randomized controlled trial (RCT) is to investigate the adjunctive effect of the application of a diode laser to treat peri-implantitis lesions by means of a non-surgical approach. A total of 30 patients is randomly allocated to two groups. The test group receives 3 x nonsurgical mechanical treatment with diode laser application whereas the control group receives the same treatment with sham laser application. The primary outcome is the mean peri-implant pocket probing depth (PPD) at 12 months. The secondary endpoints are:
- Change at deepest PPD (mm)
- Change in probing attachment level (PAL) (mm)
- Change in the % of implants with BoP / SUP
- Mean radiographic bone fill (mm) at mesial and distal sites
- Change in width of keratinized mucosa (KM) (mm)
- Change in microbial samples composition at 6 and 12 months
- Changes in patients' related outcomes measures (PROMs) by means of a Visual Analogue Scale (VAS) (range: 0-10)
- Change in peri-implant crevicular fluid (PICF) composition
- Conditions
- Peri-Implantitis
- Being tested
- Diode laser application, Sham Diode laser
- Medical subject headings
- Peri-Implantitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diode laser applicationDevice
After mechanical debridement, the pockets around the implant will be rinsed with sterile saline solution. Adjunctive diode laser (settings: 810 nm, 2.5 W, 50 Hz, 10 ms) will be applied 3x for 30 s (i.e., 90 s per appointment) using a 400-lm thick fiber (WhiteStar, Orcos Medical AG, Küsnacht, Switzerland) in the test group. In the control group, non-activated (= placebo) adjunctive diode laser will be applied. The entire treatment procedure, including mechanical debridement, will be performed at Day 0 (= baseline), 7 and 14. The laser decontamination procedure will occur by systematically moving the laser tip along the subgingival implant surface in a vertical and horizontal scanning way. The laser tip will be checked after 4-5 s for coagulation to prevent hotspots in the soft tissues.
Sham Diode laserDevice
After mechanical debridement, the pockets around the implant will be rinsed with sterile saline solution. Non-activated (= placebo) adjunctive diode laser will be applied. The entire treatment procedure, including mechanical debridement, will be performed at Day 0 (= baseline), 7 and 14. The laser decontamination procedure will occur by systematically moving the laser tip along the subgingival implant surface in a vertical and horizontal scanning way.
| Study group | Role | What they receive |
|---|---|---|
| control | Sham comparator | Non-surgical mechanical instrumentation 3x. Each time the laser will be held in place but will not be activated. Receives: Device: Sham Diode laser |
| laser | Experimental | Non-surgical mechanical instrumentation 3x with adjunctive diode laser application according to the protocol of the Department of Periodontology, University of Bern Receives: Device: Diode laser application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in peri-implant pocket probing depth (PPD)
the difference between baseline PPD and PPD after 12 months
Measured: at 12 months
Secondary outcomes (8)
Change at deepest PPD (mm)
Difference of baseline and final PPD of the deepest measurment
Measured: at 12 months
Change in probing attachment level (PAL) (mm)
Difference of attachment level from baseline to 12 months
Measured: at 12 months
Change in the % of implants with BoP / SUP
Difference between baseline and final BoP
Measured: at 12 months
Mean radiographic bone fill (mm) at mesial and distal sites
the distance from the implant shoulder to the bone crest
Measured: at 12 months
Change in width of keratinized mucosa (KM) (mm)
the difference between the baseline and final amount of KM
Measured: at 12 months
Change in microbial samples composition
Measured: at 6 and 12 months
Changes in patients' related outcomes measures (PROMs) by means of a Visual Analogue Scale (VAS) (range: 0-10)
Measured: at 12 months
Change in peri-implant crevicular fluid (PICF) composition
Measured: at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2020
- Study start1 Dec 2019
- Primary completion1 Aug 2021
- Study completion1 Jul 2022
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 University of BernThe 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
- Randomised placebo controlled monocentric trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04565886
- Sponsor's protocol ID
- 2019-01163
- Other IDs
- 2019
- Status last verified
- Aug 2022
- First submitted
- 22 Sep 2020
- Last updated
- 9 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Outcomes Following Non-surgical Mechanical Therapy of Peri-implantitis With or Without Adjunctive Diode Laser Application: A 12-month Double-blinded Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04565886
- Acronym / sponsor ID
- 2019-01163
- Conditions
- Peri-Implantitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of BernUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 1 Aug 2021 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 25 Sep 2020 (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-implantitis is a pathological condition occurring in tissues around dental implants, characterized by inflammation in the peri-implant connective tissue and progressive loss of supporting bone. The goals of peri-implantitis treatment is the resolution of peri-implant soft tissue inflammation and stabilization of the bony attachment (e.g., the level of osseointegration). For this decontamination of the implant surface is mandatory. In order to increase implant surface decontamination, several adjunctive tools have been proposed and investigated both in pre-clinical and clinical studies such as the use of photodynamic therapy and lasers. So far, no data are available to clearly demonstrate the efficacy of the adjunctive use of a diode laser in the non-surgical treatment of peri-implantitis. Therefore, the aim of the present randomized controlled trial (RCT) is to investigate the adjunctive effect of the application of a diode laser to treat peri-implantitis lesions by means of a non-surgical approach. A total of 30 patients is randomly allocated to two groups. The test group receives 3 x nonsurgical mechanical treatment with diode laser application whereas the control group receives the same treatment with sham laser application. The primary outcome is the peri-implant pocket probing depth at 12 months.
Detailed description
Peri-implantitis is a pathological condition occurring in tissues around dental implants, characterized by inflammation in the peri-implant connective tissue and progressive loss of supporting bone. Peri-implantitis is a disease with increasing incidence that, if left untreated, leads to implant loss. The etiological factors of peri-implant infections are similar to those involved in periodontal diseases. Consequently, the goals of peri-implantitis treatment must be the resolution of peri-implant soft tissue inflammation and stabilization of the bony attachment (e.g., the level of osseointegration). This can only be achieved under the condition that the majority of bacterial biofilms and hard deposits are eliminated on the implant surface to create a biologically acceptable surface conducive to wound healing. Decontamination of the implant surface is mandatory to resolve the inflammatory process and to establish healthy peri-implant tissues. To increase implant surface decontamination, several adjunctive tools have been proposed and investigated both in pre-clinical and clinical studies such as the use of photodynamic therapy and lasers. So far, no data are available to clearly demonstrate the efficacy of the adjunctive use of a diode laser in the non-surgical treatment of peri-implantitis. Therefore, the aim of the present randomized controlled trial (RCT) is to investigate the adjunctive effect of the application of a diode laser to treat peri-implantitis lesions by means of a non-surgical approach. A total of 30 patients is randomly allocated to two groups. The test group receives 3 x nonsurgical mechanical treatment with diode laser application whereas the control group receives the same treatment with sham laser application. The primary outcome is the mean peri-implant pocket probing depth (PPD) at 12 months. The secondary endpoints are:
- Change at deepest PPD (mm)
- Change in probing attachment level (PAL) (mm)
- Change in the % of implants with BoP / SUP
- Mean radiographic bone fill (mm) at mesial and distal sites
- Change in width of keratinized mucosa (KM) (mm)
- Change in microbial samples composition at 6 and 12 months
- Changes in patients' related outcomes measures (PROMs) by means of a Visual Analogue Scale (VAS) (range: 0-10)
- Change in peri-implant crevicular fluid (PICF) composition
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomised placebo controlled monocentric trial
| Arm | Type | Receives |
|---|---|---|
| control | Sham comparator | Device: Sham Diode laserNon-surgical mechanical instrumentation 3x. Each time the laser will be held in place but will not be activated. |
| laser | Experimental | Device: Diode laser applicationNon-surgical mechanical instrumentation 3x with adjunctive diode laser application according to the protocol of the Department of Periodontology, University of Bern |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- systemically healthy patients enrolled in regular supportive periodontal therapy (SPT)
- Tissue level (TL) implants with an SLA surface supporting single-unit crowns (SUCs) or fixed dental prostheses (FDPs)
- Pocket Probing Depth (PPD) > 5 mm
- Presence of BoP and /or SU
- Radiographic evidence of crestal bone loss ≤ 2mm based on periapical radiographs after delivery of the final restoration
Key exclusion criteria (7 listed)
- Systemic diseases that could interfere with the treatment outcome (e.g. uncontrolled diabetes mellitus, chemotherapy, etc.)
- Previous peri-implantitis treatment
- Full-Mouth Plaque Score (FMPS) > 25%
- Full-Mouth Bleeding Score (FMBS) > 25%
- Cigarette smoking > 10 cig./day
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 |
|---|---|---|
| Diode laser applicationAfter mechanical debridement, the pockets around the implant will be rinsed with sterile saline solution. Adjunctive diode laser (settings: 810 nm, 2.5 W, 50 Hz, 10 ms) will be applied 3x for 30 s (i.e., 90 s per appointment) using a 400-lm thick fiber (WhiteStar, Orcos Medical AG, Küsnacht, Switzerland) in the test group. In the control group, non-activated (= placebo) adjunctive diode laser will be applied. The entire treatment procedure, including mechanical debridement, will be performed at Day 0 (= baseline), 7 and 14. The laser decontamination procedure will occur by systematically moving the laser tip along the subgingival implant surface in a vertical and horizontal scanning way. The laser tip will be checked after 4-5 s for coagulation to prevent hotspots in the soft tissues. | Device | laser |
| Sham Diode laserAfter mechanical debridement, the pockets around the implant will be rinsed with sterile saline solution. Non-activated (= placebo) adjunctive diode laser will be applied. The entire treatment procedure, including mechanical debridement, will be performed at Day 0 (= baseline), 7 and 14. The laser decontamination procedure will occur by systematically moving the laser tip along the subgingival implant surface in a vertical and horizontal scanning way. | Device | control |
Primary outcome
Change in peri-implant pocket probing depth (PPD)
Time frame: at 12 months
the difference between baseline PPD and PPD after 12 months
8 secondary outcomes
Change at deepest PPD (mm)
Time frame: at 12 months
Change in probing attachment level (PAL) (mm)
Time frame: at 12 months
Change in the % of implants with BoP / SUP
Time frame: at 12 months
Mean radiographic bone fill (mm) at mesial and distal sites
Time frame: at 12 months
Change in width of keratinized mucosa (KM) (mm)
Time frame: at 12 months
Change in microbial samples composition
Time frame: at 6 and 12 months
Changes in patients' related outcomes measures (PROMs) by means of a Visual Analogue Scale (VAS) (range: 0-10)
Time frame: at 12 months
Change in peri-implant crevicular fluid (PICF) composition
Time frame: at 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 9 Aug 2022.
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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.
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 Diode laser application in people with Peri-Implantitis, run by University of Bern 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 8 inclusion and 7 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 9 Aug 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. 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?
Change in peri-implant pocket probing depth (PPD) (time frame: at 12 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 9 Aug 2022.