Peri-ImplantitisNCT04249024
Peri-implantitis, Comparing Treatments 970 nm Laser and Mucosal Flap Surgery
A study testing Laser treatment, Mucosal flap surgery and Oral hygiene instructions in people with Peri-Implantitis, run by Karolinska Institutet 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 970 nm laser combined with scaling and root planning (SRP) is clinically comparable to conventional mucosal flap surgery in… 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, Mucosal flap surgery and Oral hygiene instructions
- Type of treatment
- Pill or oral medicine, Medical device, Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 2 sitesSweden
- Study dates
- 25 Sep 2019to 21 Jun 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
- 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
Danderyd, Stockholm County, 18231
Specialist Dentistry Clinic, Karolinska Institutet, Dept. of Dental Medicine
Huddinge, Stockholm County, 14152
About this study
Official title: Comparing Treatment of Peri-implantitis With Either 970 nm Laser or Conventional Mucosal Flap Surgery - a Prospective Randomized Controlled Trial
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 970 nm laser 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 wellbeing 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 970 nm laser 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 treatment of peri-implantitis.
- To evaluate the inflammatory and microbial response after laser treatment
- Conditions
- Peri-Implantitis
- Being tested
- Laser treatment, Mucosal flap surgery, Oral hygiene instructions
- Keywords
- Peri-implantitis, Laser treatment, Surgical treatment, Randomized controlled trial, Patient reported outcomes, Clinical outcomes, Microbiology, Immunology
- 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 with a 970 nm diode laser and if calculus is present scaling and root planning (SRP). The peri-implant pocket will be radiated with the 970 nm laser, removing bacteria, diseased epithelium and granulation tissue. The laser will be used at a maximum of 20s intervals before water irrigation. Laser settings continuous wave mode and power between 1.0-1.3W. 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, and return after 7-10 days for suture removal. The surgery is a well-established treatment of peri-implantitis.
Oral hygiene instructionsBehavioural
Oral hygiene instructions of how to clean around dental implants as per individual needs in terms of access to clean and fine motor skills.
| Study group | Role | What they receive |
|---|---|---|
| Laser treatment | Experimental | Laser treatment with diode laser 970nm and settings 1.2W in intervals of max 20s, until satisfactory removal of diseased epithelium and granulation tissue. Receives: Device: Laser treatment; Behavioral: Oral hygiene instructions |
| Mucosal flap surgery | Active comparator | Conventional mucosal flap surgery of affected dental implant. Receives: Procedure: Mucosal flap surgery; Behavioral: Oral hygiene instructions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in pocket probing depth (PPD)
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: 0-6 months
Secondary outcomes (8)
Mean change in plaque index (PI)
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: 0-6 months
Mean change in bleeding on probing (BOP)
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: 0-6 months
Mean change in presence of suppuration
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: 0-6 months
Mean change in marginal bone level on radiographs
Measured on radiographs for a fixed point on the dental implant to the marginal bone level.
Measured: 0-6 months
Mean change in inflammatory response in peri-implant crevicular fluid (PICF)
Analysis of inflammatory meditators in PICF will be performed by commercially available ELISAs or multiplex assays at base line and 6 months. The analytes of interest to be tested are mainly inflammatory cytokines, chemokines, growth factors, proteases, and molecules related to bone remodeling such as for IL-1β, MMP 8, TIMP-1, CSF-1, elastase activity, and RANK-L/OPG ratio.
Measured: 0-6 months
Mean change in inflammatory response in saliva
Analysis of inflammatory meditators in stimulated saliva will be performed by commercially available ELISAs or multiplex assays at base line and 6 months. The analytes of interest to be tested are mainly inflammatory cytokines, chemokines, growth factors, proteases, and molecules related to bone remodeling such as for IL-1β, MMP 8, TIMP-1, CSF-1, elastase activity, and RANK-L/OPG ratio.
Measured: 0-6 months
Composition of the subgingival microflora
The bacterial composition in the subgingival microflora will be analyzed by quantitative real-time Polymerase Chain Reaction (qPCR).
Measured: 0-6 months
Mean change in patient reported outcome using the visual analogue scale (VAS) score
Visual analogue scale (VAS) is used to record the patients pain, discomfort and satisfaction with the treatment. The patients mark their response on a 100 mm line, with low values being no feeling of pain, discomfort or satisfaction, and high values meaning maximum pain, discomfort or satisfaction.
Measured: Baseline, directly after treatment, 10 days after and 6 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 posted30 Jan 2020
- Study start25 Sep 2019
- Primary completion21 Jun 2022
- Study completion21 Jun 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 Karolinska InstitutetThe 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Annsofi Johannsen, Karolinska Institutet
- Investigators
- Annsofi Johannsen, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04249024
- Sponsor's protocol ID
- Peri-implantitis 970 nm laser
- Status last verified
- Nov 2022
- First submitted
- 16 Oct 2019
- Last updated
- 18 Nov 2022
- 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 18 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Treatment of Peri-implantitis With Either 970 nm Laser or Conventional Mucosal Flap Surgery - a Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04249024
- Acronym / sponsor ID
- Peri-implantitis 970 nm laser
- Conditions
- Peri-Implantitis
- Keywords
- Peri-implantitis, Laser treatment, Surgical treatment, Randomized controlled trial, Patient reported outcomes, Clinical outcomes, Microbiology, Immunology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 25 Sep 2019 (actual)
- Primary completion
- 21 Jun 2022 (actual)
- Study completion
- 21 Jun 2022 (actual)
- First posted
- 30 Jan 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.
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 970 nm laser 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 wellbeing 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 970 nm laser 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 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 |
|---|---|---|
| Laser treatment | Experimental | Device: Laser treatment, Behavioral: Oral hygiene instructionsLaser treatment with diode laser 970nm and settings 1.2W in intervals of max 20s, until satisfactory removal of diseased epithelium and granulation tissue. |
| Mucosal flap surgery | Active comparator | Procedure: Mucosal flap surgery, Behavioral: Oral hygiene instructionsConventional mucosal flap surgery of affected dental implant. |
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 with a 970 nm diode laser and if calculus is present scaling and root planning (SRP). The peri-implant pocket will be radiated with the 970 nm laser, removing bacteria, diseased epithelium and granulation tissue. The laser will be used at a maximum of 20s intervals before water irrigation. Laser settings continuous wave mode and power between 1.0-1.3W. Total treatment time will vary with the depth of the pocket and size of the surrounding bone crater. | Device | Laser treatment |
| Mucosal flap surgeryThe participants will receive a conventional peri-implant mucosal flap surgery of affected implants, 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 |
| Oral hygiene instructionsOral hygiene instructions of how to clean around dental implants as per individual needs in terms of access to clean and fine motor skills. | Behavioural | Laser treatment, Mucosal flap surgery |
Primary outcome
Mean change in pocket probing depth (PPD)
Time frame: 0-6 months
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.
8 secondary outcomes
Mean change in plaque index (PI)
Time frame: 0-6 months
Mean change in bleeding on probing (BOP)
Time frame: 0-6 months
Mean change in presence of suppuration
Time frame: 0-6 months
Mean change in marginal bone level on radiographs
Time frame: 0-6 months
Mean change in inflammatory response in peri-implant crevicular fluid (PICF)
Time frame: 0-6 months
Mean change in inflammatory response in saliva
Time frame: 0-6 months
Composition of the subgingival microflora
Time frame: 0-6 months
Mean change in patient reported outcome using the visual analogue scale (VAS) score
Time frame: Baseline, directly after treatment, 10 days after and 6 months after treatment.
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 18 Nov 2022.
- 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, Mucosal flap surgery and Oral hygiene instructions in people with Peri-Implantitis, run by Karolinska Institutet 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: finished, as of the sponsor's last update on 18 Nov 2022. 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 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?
Mean change in pocket probing depth (PPD) (time frame: 0-6 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 18 Nov 2022.