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

  • STATUS
    Recruiting
  • End date
    May 17, 2022
  • participants needed
    60
  • sponsor
    Karolinska Institutet
Updated on 17 September 2021
suppuration
oral hygiene instruction

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.

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

Details
Condition Peri-Implantitis
Treatment Laser treatment, oral hygiene instructions, Mucosal flap surgery
Clinical Study IdentifierNCT04249024
SponsorKarolinska Institutet
Last Modified on17 September 2021

Eligibility

Yes No Not Sure

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
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)
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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