Peri-ImplantitisLASNCT03383120
Diode Laser for Treatment of Peri-implantitis
A study testing Laser treatment and Surgical treatment with adjunctive systemic antibiotics in people with Peri-Implantitis and Implant Complication, run by University of Geneva, Switzerland at 1 site in Switzerland.
Trial summary
The primary objective is to evaluate the clinical and patient-centered outcomes of non-surgical mechanical debridement with adjunctive repeated diode laser application (test) in comparison with conventional surgical treatment and adjunctive systemic antibiotics (control), for treatment of peri-implantitis lesions… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Peri-Implantitis, Implant Complication
- What is being tested?
- Laser treatment and Surgical treatment with adjunctive systemic antibiotics
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSwitzerland
- Study dates
- 10 Oct 2017to 30 Apr 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Informed Consent as documented by signature (Appendix Informed Consent Form)
- At least one solid screw-type titanium implant diagnosed with peri-implantitis; which is defined as at least one site with probing depth ≥5mm, bleeding on probing and/or suppuration, and radiographic evidence of crater-form bone loss ≥2 threads after insertion of the final prosthetic supra-structure.
- Sound prosthetic supra-structure.
Who cannot join
- Contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to Amoxicillin and/or Metronidazole,
- Systemic diseases that could compromise wound healing (i.e. uncontrolled diabetes mellitus, cancer, HIV or bone metabolic disorders), radiation or immunosuppressive therapy,
- Women who are pregnant or breast feeding,
- Known or suspected non-compliance, drug or alcohol abuse,
- Heavy smokers consuming >10 cigarettes/day,
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,
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- Participants not willing to attend regular dental maintenance visits and follow-up evaluations,
- Participation in another study with investigational drug within the 30 days preceding and during the present study,
- Previous enrolment into the current study,
- Active periodontal disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Clinical Trial Comparing Surgical Treatment of Peri-implantitis and Non-surgical Debridement With Adjunctive Diode Laser Therapy
The primary objective is to evaluate the clinical and patient-centered outcomes of non-surgical mechanical debridement with adjunctive repeated diode laser application (test) in comparison with conventional surgical treatment and adjunctive systemic antibiotics (control), for treatment of peri-implantitis lesions, following an observation period of one year.
Read the detailed description
Peri-implantitis is a major complication for dental implant patients, with its prevalence estimated in the order of 10% of implants and 20% of patients after 5 to 10 years of implant placement. When left untreated, peri-implantitis may cause progressive tissue destruction, esthetic complications and, eventually, implant loss. Despite numerous clinical trials and systematic reviews, studies have failed to identify a standardized protocol for the treatment of such conditions. Still, current literature and expert opinions recommend mechanical debridement of the implant followed by early evaluation and surgical intervention, implant decontamination using a wide variety of mechanical and chemical methods, then adjunctive systematic antibiotics. However, given the aggressive nature of surgical interventions, the inherent difficulty of decontaminating the implants' rough surfaces with conventional methods, in addition to the growing concerns over antibiotic resistance, the search for alternative approaches has become imperative. Since implant decontamination is the key aspect to resolution of peri-implantitis, different mechanical and chemical methods have been tested in that respect. In recent years, lasers have been attracting significant attention in this particular field. Diode lasers, in particular, have been shown to have potent bactericidal and photobiomodulatory effects promoting wound healing and tissue regeneration. Therefore, the aim of this randomized controlled clinical trial is to evaluate the clinical and patient-centered outcomes of non-surgical debridement with adjunctive repeated diode laser application in comparison with conventional surgical treatment with adjunctive systemic antibiotics for treatment of peri-implantitis lesions following an observation period of one year.
The primary objective is to evaluate the clinical and patient-centered outcomes of non-surgical mechanical debridement with adjunctive repeated diode laser application (test) in comparison with conventional surgical treatment and adjunctive systemic antibiotics (control), for treatment of peri-implantitis lesions, following an observation period of one year.
40 subjects will be randomly distributed into two parallel groups:
- Test group (n= 20); receiving non-surgical mechanical debridement and adjunctive diode laser application at days 0, 7 and 14.
- Control group (n= 20); receiving initial mechanical debridement at day 0, followed by open flap debridement and prescription of post-operative systemic antimicrobials at day 14.
- Conditions
- Peri-Implantitis, Implant Complication
- Being tested
- Laser treatment, Surgical treatment with adjunctive systemic antibiotics
- Keywords
- Peri-implantitis, Diode laser, Surgical debridement
- Medical subject headings
- Peri-Implantitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser treatmentDevice
Also called Test
Laser treatment of the peri-implantitis lesion includes mechanical debridement of the implant using an ultrasonic device and plastic curettes followed by diode laser sub-mucosal application for 90 seconds. This is repeated two more times at one-week intervals.
Surgical treatment with adjunctive systemic antibioticsProcedure or surgery
Also called Control
Mechanical debridement of the implant will be done in a similar manner to the test group (without laser application) followed by open flap debridement 2 weeks after, and post-operative prescription of Amoxicillin and Metronidazole systemic antibiotics 3 times per day for a period of 1 week
| Study group | Role | What they receive |
|---|---|---|
| Laser | Experimental | Mechanical debridement of the implant surface using an ultra-sonic device with saline irrigation and plastic curettes, followed by soft tissue curettage using a metallic curette. Adjunctive sub-mucosal diode laser application according to the instructions of the manufacturer (settings: 810 nm, 2.5 W, 50 Hz, 10 ms), 3x for 30 seconds, using a 400-µm thick fiber (Doctor Smile Wiser diode laser, Orcos Medical AG, Küsnacht, Switzerland), will be performed three times at one week intervals (days 0, 7, and 14). Receives: Device: Laser treatment |
| Surgery | Active comparator | Active control includes mechanical debridement of the implant surface using an ultra-sonic device with saline irrigation and plastic curettes, followed by soft tissue curettage using a metallic curette at day 1. An open flap debridement procedure is performed at day 14 using normal saline for implant decontamination. Adjunctive systemic antimicrobials will be prescribed; Amoxi-mepha 500mg 3x/day and Metronidazole 500mg 3x/day, for 1 week. A chlorhexidine 0.2% mouth rinse will also be prescribed 2x/day for one week. Suture removal and prophylaxis are performed 7-10 days post-operatively. Receives: Procedure: Surgical treatment with adjunctive systemic antibiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resolution of the peri-implantitis
Defined as A absence of probing depths > 4 mm, bleeding on probing or suppuration at the end of the observation period
Measured: 12 months
Types and frequencies of adverse events
Any adverse events related or unrelated to the treatment administered is recorded at the time and appropriate treatment is performed. The frequency, duration and intensity is also recorded.
Measured: 12 months
Patient reported outcomes at 1 week
A visual analogue scale is used to evaluate post-operative discomfort and patient's perception of the administered treatment 1 week post-operatively.The scale measures a total of 100 mm ranging between 0-100; 0 indicating absence of pain and 100 being the worst pain imaginable.
Measured: 1 week post-operatively
Patient reported outcomes at 12 months
A visual analogue scale is used to evaluate general patient's perception of the administered treatment 12 months post-operatively.The scale measures a total of 100 mm ranging between 0-100; 0 indicating lack of discomfort or pain and complete satisfaction and 100 being completely unsatisfied and/or with persisting pain or other symptoms.
Measured: 12 months
Secondary outcomes (4)
Change in marginal bone levels
Changes in peri-implant marginal bone levels are measured on intra-oral radiographs taken at baseline and 12 months post-operatively. Two independent examiners perform measurements and mean values are taken. This outcome is only calculated 12 months postoperatively.
Measured: 12 months
Differences between groups regarding changes in mean marginal bone level changes
Comparison in mean marginal bone level changes (outcome 4) are performed between the test and control groups
Measured: 12 months
Number of residual pockets > 4 mm
Number of residual peri-implant pockets exceeding 4 mm are measured around all included implants at the end of the observation period to asses the presence of any residual peri-implant soft-tissue inflammation
Measured: 12 months
Changes in probing depth
The change in mean probing depth between baseline and 12 months is calculated to assess treatment outcomes and disease resolution around all included implants. This outcome is calculated only once 12 months post-operatively.
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 posted26 Dec 2017
- Study start10 Oct 2017
- Primary completion30 Oct 2020
- Study completion30 Apr 2021
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
- Model description
- Prospective, single-centre, superiority, randomized, controlled clinical trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Geneva, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dena Hashim, University of Geneva, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03383120
- Sponsor's protocol ID
- 2016-02205
- Other IDs
- 2016
- Acronym
- LAS
- Status last verified
- May 2021
- First submitted
- 14 Nov 2017
- Last updated
- 4 May 2021
- 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 4 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Clinical Trial Comparing Surgical Treatment of Peri-implantitis and Non-surgical Debridement With Adjunctive Diode Laser Therapy
- ClinicalTrials.gov ID
- NCT03383120
- Acronym / sponsor ID
- LAS / 2016-02205
- Conditions
- Peri-Implantitis, Implant Complication
- Keywords
- Peri-implantitis, Diode laser, Surgical debridement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Geneva, SwitzerlandUniversity, hospital or other
- Study start
- 10 Oct 2017 (actual)
- Primary completion
- 30 Oct 2020 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 26 Dec 2017 (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 primary objective is to evaluate the clinical and patient-centered outcomes of non-surgical mechanical debridement with adjunctive repeated diode laser application (test) in comparison with conventional surgical treatment and adjunctive systemic antibiotics (control), for treatment of peri-implantitis lesions, following an observation period of one year.
Detailed description
Peri-implantitis is a major complication for dental implant patients, with its prevalence estimated in the order of 10% of implants and 20% of patients after 5 to 10 years of implant placement. When left untreated, peri-implantitis may cause progressive tissue destruction, esthetic complications and, eventually, implant loss. Despite numerous clinical trials and systematic reviews, studies have failed to identify a standardized protocol for the treatment of such conditions. Still, current literature and expert opinions recommend mechanical debridement of the implant followed by early evaluation and surgical intervention, implant decontamination using a wide variety of mechanical and chemical methods, then adjunctive systematic antibiotics. However, given the aggressive nature of surgical interventions, the inherent difficulty of decontaminating the implants' rough surfaces with conventional methods, in addition to the growing concerns over antibiotic resistance, the search for alternative approaches has become imperative. Since implant decontamination is the key aspect to resolution of peri-implantitis, different mechanical and chemical methods have been tested in that respect. In recent years, lasers have been attracting significant attention in this particular field. Diode lasers, in particular, have been shown to have potent bactericidal and photobiomodulatory effects promoting wound healing and tissue regeneration. Therefore, the aim of this randomized controlled clinical trial is to evaluate the clinical and patient-centered outcomes of non-surgical debridement with adjunctive repeated diode laser application in comparison with conventional surgical treatment with adjunctive systemic antibiotics for treatment of peri-implantitis lesions following an observation period of one year.
The primary objective is to evaluate the clinical and patient-centered outcomes of non-surgical mechanical debridement with adjunctive repeated diode laser application (test) in comparison with conventional surgical treatment and adjunctive systemic antibiotics (control), for treatment of peri-implantitis lesions, following an observation period of one year.
40 subjects will be randomly distributed into two parallel groups:
- Test group (n= 20); receiving non-surgical mechanical debridement and adjunctive diode laser application at days 0, 7 and 14.
- Control group (n= 20); receiving initial mechanical debridement at day 0, followed by open flap debridement and prescription of post-operative systemic antimicrobials at day 14.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective, single-centre, superiority, randomized, controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Laser | Experimental | Device: Laser treatmentMechanical debridement of the implant surface using an ultra-sonic device with saline irrigation and plastic curettes, followed by soft tissue curettage using a metallic curette. Adjunctive sub-mucosal diode laser application according to the instructions of the manufacturer (settings: 810 nm, 2.5 W, 50 Hz, 10 ms), 3x for 30 seconds, using a 400-µm thick fiber (Doctor Smile Wiser diode laser, Orcos Medical AG, Küsnacht, Switzerland), will be performed three times at one week intervals (days 0, 7, and 14). |
| Surgery | Active comparator | Procedure: Surgical treatment with adjunctive systemic antibioticsActive control includes mechanical debridement of the implant surface using an ultra-sonic device with saline irrigation and plastic curettes, followed by soft tissue curettage using a metallic curette at day 1. An open flap debridement procedure is performed at day 14 using normal saline for implant decontamination. Adjunctive systemic antimicrobials will be prescribed; Amoxi-mepha 500mg 3x/day and Metronidazole 500mg 3x/day, for 1 week. A chlorhexidine 0.2% mouth rinse will also be prescribed 2x/day for one week. Suture removal and prophylaxis are performed 7-10 days post-operatively. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Informed Consent as documented by signature (Appendix Informed Consent Form)
- At least one solid screw-type titanium implant diagnosed with peri-implantitis; which is defined as at least one site with probing depth ≥5mm, bleeding on probing and/or suppuration, and radiographic evidence of crater-form bone loss ≥2 threads after insertion of the final prosthetic supra-structure.
- Sound prosthetic supra-structure.
Key exclusion criteria (10 listed)
- Contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to Amoxicillin and/or Metronidazole,
- Systemic diseases that could compromise wound healing (i.e. uncontrolled diabetes mellitus, cancer, HIV or bone metabolic disorders), radiation or immunosuppressive therapy,
- Women who are pregnant or breast feeding,
- Known or suspected non-compliance, drug or alcohol abuse,
- Heavy smokers consuming >10 cigarettes/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 |
|---|---|---|
| Laser treatmentAlso: TestLaser treatment of the peri-implantitis lesion includes mechanical debridement of the implant using an ultrasonic device and plastic curettes followed by diode laser sub-mucosal application for 90 seconds. This is repeated two more times at one-week intervals. | Device | Laser |
| Surgical treatment with adjunctive systemic antibioticsAlso: ControlMechanical debridement of the implant will be done in a similar manner to the test group (without laser application) followed by open flap debridement 2 weeks after, and post-operative prescription of Amoxicillin and Metronidazole systemic antibiotics 3 times per day for a period of 1 week | Procedure or surgery | Surgery |
Primary outcome
Resolution of the peri-implantitis
Time frame: 12 months
Defined as A absence of probing depths > 4 mm, bleeding on probing or suppuration at the end of the observation period
Types and frequencies of adverse events
Time frame: 12 months
Any adverse events related or unrelated to the treatment administered is recorded at the time and appropriate treatment is performed. The frequency, duration and intensity is also recorded.
Patient reported outcomes at 1 week
Time frame: 1 week post-operatively
A visual analogue scale is used to evaluate post-operative discomfort and patient's perception of the administered treatment 1 week post-operatively.The scale measures a total of 100 mm ranging between 0-100; 0 indicating absence of pain and 100 being the worst pain imaginable.
Patient reported outcomes at 12 months
Time frame: 12 months
A visual analogue scale is used to evaluate general patient's perception of the administered treatment 12 months post-operatively.The scale measures a total of 100 mm ranging between 0-100; 0 indicating lack of discomfort or pain and complete satisfaction and 100 being completely unsatisfied and/or with persisting pain or other symptoms.
4 secondary outcomes
Change in marginal bone levels
Time frame: 12 months
Differences between groups regarding changes in mean marginal bone level changes
Time frame: 12 months
Number of residual pockets > 4 mm
Time frame: 12 months
Changes in probing depth
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 4 May 2021.
- 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.
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 Laser treatment and Surgical treatment with adjunctive systemic antibiotics in people with Peri-Implantitis and Implant Complication, run by University of Geneva, Switzerland 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 3 inclusion and 10 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 4 May 2021. 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. 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?
Resolution of the peri-implantitis (time frame: 12 months). The study lists 4 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 4 May 2021.