NCT04249024

Peri-implantitis, Comparing Treatments 970 nm Laser and Mucosal Flap Surgery

Comparing Treatment of Peri-implantitis With Either 970 nm Laser or Conventional Mucosal Flap Surgery - a Prospective Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Karolinska Institutet · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Peri-Implantitis

Interventions

Type	Name	Description
DEVICE	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.
PROCEDURE	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.
BEHAVIORAL	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.

Timeline

• Start date: 2019-09-25
• Primary completion: 2022-06-21
• Completion: 2022-06-21
• First posted: 2020-01-30
• Last updated: 2022-11-18

Locations

2 sites across 1 country: Sweden