Comparing Two Treatment Modalities of Peri-implantitis - Blue Laser (445 nm) and Conventional Flap Surgery

Sirona Dental Systems

Status: Withdrawn

Conditions: Peri-Implantitis

Treatments: Device: Laser treatment; Procedure: Mucosal flap surgery

Study type: Interventional

Funder types: Industry

Identifiers

NCT03624257

CIV-1 8-06-024304 (Other Identifier)

Peri-implantitis 445 nm laser

Details and patient eligibility

About

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.

Full 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

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups

Scaling and root planning + Laser treatment

Experimental group

Treatment:

Device: Laser treatment

Mucosal flap surgery

Active Comparator group

Treatment:

Procedure: Mucosal flap surgery