Clinical trial NCT03624257: Comparing Two Treatment Modalities of Peri-implantitis - Blue Laser (445 nm) and Conventional Flap Surgery
Official title: Comparing Two Treatment Modalities of Peri-implantitis - Blue Laser (445 nm) and Conventional Flap Surgery
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Peri-Implantitis
Keywords: Laser treatment
surgical treatment
patient reported outcomes
microbiology
immunology
radiological examination
Lead sponsor: Sirona Dental Systems GmbH
Sponsor class: INDUSTRY
First posted: 2018-08-10
Enrollment: 0
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 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

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 from baseline in Pocket probing depth (PPD) at 6 months after treatment.
timeFrame: At baseline and 6 months post treatment
Secondary outcomes:
measure: Mean change from baseline in Plaque index (PI) at 6 months after treatment.
timeFrame: At baseline and 6 months post treatment
measure: Mean change from baseline in Bleeding on probing (BOP) at 6 months after treatment.
timeFrame: At baseline and 6 months post treatment
measure: Mean change from baseline in Recession of the marginal mucosa at 6 months after treatment.
timeFrame: At baseline and 6 months post treatment
measure: Mean change from baseline in Presence of suppuration at 6 months after treatment.
timeFrame: At baseline and 6 months post treatment
measure: Mean change from baseline in Marginal bone level on radiographs at 6 months after treatment.
timeFrame: At baseline and 6 months post treatment
measure: Mean change from baseline in Patient reported outcome using the VAS score directly post treatment.
timeFrame: At baseline and immediately post treatment.
measure: Mean change from baseline in Patient reported outcome using the VAS score at 10 days post treatment.
timeFrame: At baseline and 10 days post treatment.
measure: Mean change from baseline in the inflammatory response in the inflammatory exudates at 6 months after treatment.
timeFrame: At baseline and 6 months post treatment
measure: Bacterial composition of the subgingival microflora
timeFrame: At baseline and 6 months post treatment
Other outcomes:
Locations:
city: Danderyd
country: Sweden
facility: Danakliniken Specialist Dentistry, Mörby Centrum floor 5
city: Huddinge
country: Sweden
facility: Specialist Dentistry Clinic, Karolinska Institutet, Dept. of Dental Medicine, Karolinska Institutet
Study officials:
affiliation: Karolinska Institutet
name: Annsofi Johannsen
role: PRINCIPAL_INVESTIGATOR
References: