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

NCT03624257 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2019-07-15

No results posted yet for this study

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.

Conditions

  • Peri-Implantitis

Interventions

DEVICE

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.

PROCEDURE

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.

Sponsors & Collaborators

  • Sirona Dental Systems GmbH

    lead INDUSTRY

Principal Investigators

  • Annsofi Johannsen · Karolinska Institutet

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-30
Primary Completion
2020-06-30
Completion
2020-06-30

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03624257 on ClinicalTrials.gov