Peri-ImplantitisNCT03624257
Comparing Two Treatment Modalities of Peri-implantitis - Blue Laser (445 nm) and Conventional Flap Surgery
A study testing Laser treatment and Mucosal flap surgery in people with Peri-Implantitis, run by Sirona Dental Systems GmbH at 2 sites in Sweden.
Trial summary
A clinical trial comparing laser treatment and conventional mucosal flap surgery for treatment of peri-implantitis. The main aim of the study is to evaluate if treatment of peri-implantitis with a novel blue laser (445 nm) combined with scaling and root planning (SRP) is clinically comparable to conventional mucosal… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peri-Implantitis
- What is being tested?
- Laser treatment and Mucosal flap surgery
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesSweden
- Study dates
- Sep 2018to Jun 2020
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signs of peri-implantitis around one or more dental implants. All criteria below need to be fulfilled for inclusion.
- Presence of pocket probing depth (PPD) > 5 mm
- Bleeding on probing/suppuration (BOP/Pus)
- At least 2 mm loss of bone, visible on radiographs, after initial osseointegration.
- ≥ 18 years old.
- Patient able to understand Swedish.
Who cannot join
- Antibiotic treatment 6 months prior to baseline.
- Peri-implant treatment 6 months prior to baseline.
- Myocardial infarction 6 months prior to baseline.
- Previous radiation treatment in the affected jaw area.
- Previous i.v. bisphosphonate treatment.
- Moderate or severe impairment of cognitive function (e.g. dementia).
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites
Danakliniken Specialist Dentistry, Mörby Centrum floor 5
Danderyd, 18231
Specialist Dentistry Clinic, Karolinska Institutet, Dept. of Dental Medicine, Karolinska Institutet
Huddinge, 14152
About this study
A clinical trial comparing laser treatment and conventional mucosal flap surgery for treatment of peri-implantitis. The main aim of the study is to evaluate if treatment of peri-implantitis with a novel blue laser (445 nm) combined with scaling and root planning (SRP) is clinically comparable to conventional mucosal flap surgery in terms of pocket probing depth reduction.
Read the detailed description
The present project aims to evaluate a novel method in treating peri-implantitis, with focus on decreasing the patient's suffering as well as disease progression. Peri-implantitis has a direct influence on both physical and psychological well-being and have been related to difficulty in chewing due to loss of implants, bad esthetic appearance as well as high costs. Therefore, it is of importance for the individual as well as for the society to thoroughly investigate any new treatment approaches.
The study is a prospective randomized clinical trial comparing laser treatment (test group) and conventional mucosal flap surgery (active control group). Assessment of clinical variables at baseline and after 6 months. Patient reported outcomes at baseline, directly after treatment and after 10 days.
Primary Objective:
To evaluate if treatment of peri-implantitis with a novel blue laser (445 nm) combined with scaling and root planning (SRP) is clinically comparable to conventional mucosal flap surgery in terms of pocket probing depth reduction.
Secondary Objectives:
- To evaluate other clinical and radiological variables connected to peri-implantitis and the inflammation surrounding the dental implant.
- To evaluate the patient experience of a novel blue laser for treatment of peri-implantitis.
- To evaluate the inflammatory and microbial response after laser treatment
- Conditions
- Peri-Implantitis
- Being tested
- Laser treatment, Mucosal flap surgery
- Keywords
- Laser treatment, surgical treatment, patient reported outcomes, microbiology, immunology, radiological examination
- 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
The participants in the laser group are treated by a combination of scaling and root planning (SRP) and 445 nm diode laser. The peri-implant pocket will be radiated with the 445 nm laser, removing bacteria, diseased epithelium and granulation tissue. The Power setting on the laser will be 0.7 W continuous wave and will be used at maximum 20 s Before cooling water is applied. Total treatment time will vary with the depth of the pocket and size of the surrounding bone crater.
Mucosal flap surgeryProcedure or surgery
The participants will receive a conventional peri-implant mucosal flap surgery of affected implants, in combination with scaling and root planning (SRP), and return after 7-10 days for suture removal. The surgery is a well-established treatment of peri-implantitis.
| Study group | Role | What they receive |
|---|---|---|
| Scaling and root planning + Laser treatment | Experimental | Not described Receives: Device: Laser treatment |
| Mucosal flap surgery | Active comparator | Not described Receives: Procedure: Mucosal flap surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change from baseline in Pocket probing depth (PPD) at 6 months after treatment.
Pocket probing depth (PPD) will be measured by a 1 mm graded pocket probe from the bottom of the peri-implant pocket to the marginal mucosa and will be registered on 4 surfaces surrounding the implant.
Measured: At baseline and 6 months post treatment
Secondary outcomes (9)
Mean change from baseline in Plaque index (PI) at 6 months after treatment.
Plaque index (PI) will be measured at 4 sites per implant and assessed as per cent of the total amount of measured implant surfaces.
Measured: At baseline and 6 months post treatment
Mean change from baseline in Bleeding on probing (BOP) at 6 months after treatment.
BOP will be registered on 4 surfaces surrounding the implant after probing the peri-implant pocket with a pocket probe, up to 20 s after the provocation with the probe.
Measured: At baseline and 6 months post treatment
Mean change from baseline in Recession of the marginal mucosa at 6 months after treatment.
Recession of the marginal mucosa will be measured from a per implant decided fixed point like the shoulder of the implant or the edge of the prosthetic to the marginal mucosa. Registered on 4 surfaces surrounding the implant.
Measured: At baseline and 6 months post treatment
Mean change from baseline in Presence of suppuration at 6 months after treatment.
Presence of suppuration will be registered on 4 surfaces surrounding the implant after probing the peri-implant pocket with a pocket probe, up to 20 s after the provocation with the probe.
Measured: At baseline and 6 months post treatment
Mean change from baseline in Marginal bone level on radiographs at 6 months after treatment.
Measured: At baseline and 6 months post treatment
Mean change from baseline in Patient reported outcome using the VAS score directly post treatment.
Visual analogue scale (VAS) is used to record the patients pain, discomfort and satisfaction with the treatment.
Measured: At baseline and immediately post treatment.
Mean change from baseline in Patient reported outcome using the VAS score at 10 days post treatment.
Visual analogue scale (VAS) is used to record the patients pain, discomfort and satisfaction with the treatment.
Measured: At baseline and 10 days post treatment.
Mean change from baseline in the inflammatory response in the inflammatory exudates at 6 months after treatment.
Analysis of inflammatory meditators in gingival crevicular fluid (GCF) and saliva will be performed by commercially available ELISAs or multiplex assays.
Measured: At baseline and 6 months post treatment
Bacterial composition of the subgingival microflora
The bacterial composition in the subgingival microflora will be analyzed by quantitative real-time Polymerase Chain Reaction (qPCR).
Measured: At baseline and 6 months post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2018
- Study startSep 2018 (estimated)
- Primary completionJun 2020 (estimated)
- Study completionJun 2020 (estimated)
Why it stopped: Sponsor decision: priority change (Study approved by ethics committee and Swedish competent authority)
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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sirona Dental Systems GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Annsofi Johannsen, Karolinska Institutet
- Investigators
- Annsofi Johannsen, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03624257
- Sponsor's protocol ID
- Peri-implantitis 445 nm laser
- Other IDs
- CIV-1 8-06-024304
- Status last verified
- Jul 2019
- First submitted
- 7 Aug 2018
- Last updated
- 15 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Two Treatment Modalities of Peri-implantitis - Blue Laser (445 nm) and Conventional Flap Surgery
- ClinicalTrials.gov ID
- NCT03624257
- Acronym / sponsor ID
- Peri-implantitis 445 nm laser
- Conditions
- Peri-Implantitis
- Keywords
- Laser treatment, surgical treatment, patient reported outcomes, microbiology, immunology, radiological examination
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor decision: priority change (Study approved by ethics committee and Swedish competent authority)
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sirona Dental Systems GmbHIndustry (pharma, biotech, devices)
- Study start
- Sep 2018 (estimated)
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 10 Aug 2018 (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.
A clinical trial comparing laser treatment and conventional mucosal flap surgery for treatment of peri-implantitis. The main aim of the study is to evaluate if treatment of peri-implantitis with a novel blue laser (445 nm) combined with scaling and root planning (SRP) is clinically comparable to conventional mucosal flap surgery in terms of pocket probing depth reduction.
Detailed description
The present project aims to evaluate a novel method in treating peri-implantitis, with focus on decreasing the patient's suffering as well as disease progression. Peri-implantitis has a direct influence on both physical and psychological well-being and have been related to difficulty in chewing due to loss of implants, bad esthetic appearance as well as high costs. Therefore, it is of importance for the individual as well as for the society to thoroughly investigate any new treatment approaches.
The study is a prospective randomized clinical trial comparing laser treatment (test group) and conventional mucosal flap surgery (active control group). Assessment of clinical variables at baseline and after 6 months. Patient reported outcomes at baseline, directly after treatment and after 10 days.
Primary Objective:
To evaluate if treatment of peri-implantitis with a novel blue laser (445 nm) combined with scaling and root planning (SRP) is clinically comparable to conventional mucosal flap surgery in terms of pocket probing depth reduction.
Secondary Objectives:
- To evaluate other clinical and radiological variables connected to peri-implantitis and the inflammation surrounding the dental implant.
- To evaluate the patient experience of a novel blue laser for treatment of peri-implantitis.
- To evaluate the inflammatory and microbial response after laser treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Scaling and root planning + Laser treatment | Experimental | Device: Laser treatment |
| Mucosal flap surgery | Active comparator | Procedure: Mucosal flap surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Signs of peri-implantitis around one or more dental implants. All criteria below need to be fulfilled for inclusion.
- ≥ 18 years old.
- Patient able to understand Swedish.
Key exclusion criteria (6 listed)
- Antibiotic treatment 6 months prior to baseline.
- Peri-implant treatment 6 months prior to baseline.
- Myocardial infarction 6 months prior to baseline.
- Previous radiation treatment in the affected jaw area.
- Previous i.v. bisphosphonate treatment.
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 treatmentThe participants in the laser group are treated by a combination of scaling and root planning (SRP) and 445 nm diode laser. The peri-implant pocket will be radiated with the 445 nm laser, removing bacteria, diseased epithelium and granulation tissue. The Power setting on the laser will be 0.7 W continuous wave and will be used at maximum 20 s Before cooling water is applied. Total treatment time will vary with the depth of the pocket and size of the surrounding bone crater. | Device | Scaling and root planning + Laser treatment |
| Mucosal flap surgeryThe participants will receive a conventional peri-implant mucosal flap surgery of affected implants, in combination with scaling and root planning (SRP), and return after 7-10 days for suture removal. The surgery is a well-established treatment of peri-implantitis. | Procedure or surgery | Mucosal flap surgery |
Primary outcome
Mean change from baseline in Pocket probing depth (PPD) at 6 months after treatment.
Time frame: At baseline and 6 months post treatment
Pocket probing depth (PPD) will be measured by a 1 mm graded pocket probe from the bottom of the peri-implant pocket to the marginal mucosa and will be registered on 4 surfaces surrounding the implant.
9 secondary outcomes
Mean change from baseline in Plaque index (PI) at 6 months after treatment.
Time frame: At baseline and 6 months post treatment
Mean change from baseline in Bleeding on probing (BOP) at 6 months after treatment.
Time frame: At baseline and 6 months post treatment
Mean change from baseline in Recession of the marginal mucosa at 6 months after treatment.
Time frame: At baseline and 6 months post treatment
Mean change from baseline in Presence of suppuration at 6 months after treatment.
Time frame: At baseline and 6 months post treatment
Mean change from baseline in Marginal bone level on radiographs at 6 months after treatment.
Time frame: At baseline and 6 months post treatment
Mean change from baseline in Patient reported outcome using the VAS score directly post treatment.
Time frame: At baseline and immediately post treatment.
Mean change from baseline in Patient reported outcome using the VAS score at 10 days post treatment.
Time frame: At baseline and 10 days post treatment.
Mean change from baseline in the inflammatory response in the inflammatory exudates at 6 months after treatment.
Time frame: At baseline and 6 months post treatment
Bacterial composition of the subgingival microflora
Time frame: At baseline and 6 months post treatment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2019.
- Individual participant dataSharing planned: No
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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.
Annsofi Johannsen principal investigator
Karolinska Institutet
2 sites 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 Mucosal flap surgery in people with Peri-Implantitis, run by Sirona Dental Systems GmbH at 2 sites in Sweden.
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 6 inclusion and 6 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: withdrawn, as of the sponsor's last update on 15 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. 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 was withdrawn before enrolling participants, so there are no results.
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?
Mean change from baseline in Pocket probing depth (PPD) at 6 months after treatment. (time frame: At baseline and 6 months post 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 15 Jul 2019.