Peri-implantitis, Comparing Treatments 970 nm Laser and Mucosal Flap Surgery
NCT ID: NCT04249024
Last Updated: 2022-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
26 participants
INTERVENTIONAL
2019-09-25
2022-06-21
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Laser treatment
Laser treatment with diode laser 970nm and settings 1.2W in intervals of max 20s, until satisfactory removal of diseased epithelium and granulation tissue.
Laser treatment
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.
Oral hygiene instructions
Oral hygiene instructions of how to clean around dental implants as per individual needs in terms of access to clean and fine motor skills.
Mucosal flap surgery
Conventional mucosal flap surgery of affected dental implant.
Mucosal flap 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 instructions
Oral hygiene instructions of how to clean around dental implants as per individual needs in terms of access to clean and fine motor skills.
Interventions
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Laser treatment
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 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 instructions
Oral hygiene instructions of how to clean around dental implants as per individual needs in terms of access to clean and fine motor skills.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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).
18 Years
ALL
No
Sponsors
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Karolinska Institutet
OTHER
Responsible Party
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Annsofi Johannsen
Associate professor
Principal Investigators
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Annsofi Johannsen
Role: PRINCIPAL_INVESTIGATOR
Karolinska Institutet
Locations
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Danakliniken Specialist Dentistry
Danderyd, Stockholm County, Sweden
Specialist Dentistry Clinic, Karolinska Institutet, Dept. of Dental Medicine
Huddinge, Stockholm County, Sweden
Countries
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Other Identifiers
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Peri-implantitis 970 nm laser
Identifier Type: -
Identifier Source: org_study_id
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