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

NCT ID: NCT03624257

Last Updated: 2019-07-15

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-30
• Study Completion Date: 2020-06-30

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

Conditions

Peri-Implantitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Scaling and root planning + Laser treatment

Group Type: EXPERIMENTAL

Laser treatment

Intervention Type: DEVICE

The participants in the laser group are treated by a combination of scaling and root planning (SRP) and 445 nm diode laser. The peri-implant pocket will be radiated with the 445 nm laser, removing bacteria, diseased epithelium and granulation tissue. The Power setting on the laser will be 0.7 W continuous wave and will be used at maximum 20 s Before cooling water is applied. Total treatment time will vary with the depth of the pocket and size of the surrounding bone crater.

Mucosal flap surgery

Group Type: ACTIVE_COMPARATOR

Mucosal flap surgery

Intervention Type: PROCEDURE

The participants will receive a conventional peri-implant mucosal flap surgery of affected implants, in combination with scaling and root planning (SRP), and return after 7-10 days for suture removal. The surgery is a well-established treatment of peri-implantitis.

Interventions

Laser treatment

The participants in the laser group are treated by a combination of scaling and root planning (SRP) and 445 nm diode laser. The peri-implant pocket will be radiated with the 445 nm laser, removing bacteria, diseased epithelium and granulation tissue. The Power setting on the laser will be 0.7 W continuous wave and will be used at maximum 20 s Before cooling water is applied. Total treatment time will vary with the depth of the pocket and size of the surrounding bone crater.

Intervention Type: DEVICE

Mucosal flap surgery

The participants will receive a conventional peri-implant mucosal flap surgery of affected implants, in combination with scaling and root planning (SRP), and return after 7-10 days for suture removal. The surgery is a well-established treatment of peri-implantitis.

Intervention Type: PROCEDURE

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sirona Dental Systems GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Annsofi Johannsen

Registered Dental Hygienist (RDH); Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Annsofi Johannsen

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

Danakliniken Specialist Dentistry, Mörby Centrum floor 5

Danderyd, , Sweden

Specialist Dentistry Clinic, Karolinska Institutet, Dept. of Dental Medicine, Karolinska Institutet

Huddinge, , Sweden

Countries

Sweden

Other Identifiers

CIV-1 8-06-024304

Identifier Type: OTHER

Identifier Source: secondary_id

Peri-implantitis 445 nm laser

Identifier Type: -

Identifier Source: org_study_id