Clinical trial NCT04249024: Peri-implantitis, Comparing Treatments 970 nm Laser and Mucosal Flap Surgery
Official title: Comparing Treatment of Peri-implantitis With Either 970 nm Laser or Conventional Mucosal Flap Surgery - a Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peri-Implantitis
Keywords: Peri-implantitis
Laser treatment
Surgical treatment
Randomized controlled trial
Patient reported outcomes
Clinical outcomes
Microbiology
Immunology
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2020-01-30
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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).

Primary outcomes:
measure: Mean change in pocket probing depth (PPD)
timeFrame: 0-6 months
Secondary outcomes:
measure: Mean change in plaque index (PI)
timeFrame: 0-6 months
measure: Mean change in bleeding on probing (BOP)
timeFrame: 0-6 months
measure: Mean change in presence of suppuration
timeFrame: 0-6 months
measure: Mean change in marginal bone level on radiographs
timeFrame: 0-6 months
measure: Mean change in inflammatory response in peri-implant crevicular fluid (PICF)
timeFrame: 0-6 months
measure: Mean change in inflammatory response in saliva
timeFrame: 0-6 months
measure: Composition of the subgingival microflora
timeFrame: 0-6 months
measure: Mean change in patient reported outcome using the visual analogue scale (VAS) score
timeFrame: Baseline, directly after treatment, 10 days after and 6 months after treatment.
Other outcomes:
Locations:
city: Danderyd
country: Sweden
facility: Danakliniken Specialist Dentistry
state: Stockholms Län
city: Huddinge
country: Sweden
facility: Specialist Dentistry Clinic, Karolinska Institutet, Dept. of Dental Medicine
state: Stockholms Län
Study officials:
affiliation: Karolinska Institutet
name: Annsofi Johannsen
role: PRINCIPAL_INVESTIGATOR
References: