NCT04249024

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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2019

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 25, 2019

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

October 16, 2019

Completed
4 months until next milestone

First Posted

Study publicly available on registry

January 30, 2020

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 21, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 21, 2022

Completed
Last Updated

November 18, 2022

Status Verified

November 1, 2022

Enrollment Period

2.7 years

First QC Date

October 16, 2019

Last Update Submit

November 16, 2022

Conditions

Peri-Implantitis

Keywords

Peri-implantitisLaser treatmentSurgical treatmentRandomized controlled trialPatient reported outcomesClinical outcomesMicrobiologyImmunology

Outcome Measures

Primary Outcomes (1)

  • Mean change in pocket probing depth (PPD)

    Pocket probing depth (PPD) will be measured by a 1 mm graded pocket probe from the bottom of the peri-implant pocket to the marginal mucosa and will be registered on 4 surfaces surrounding the implant.

    0-6 months

Secondary Outcomes (8)

  • Mean change in plaque index (PI)

    0-6 months

  • Mean change in bleeding on probing (BOP)

    0-6 months

  • Mean change in presence of suppuration

    0-6 months

  • Mean change in marginal bone level on radiographs

    0-6 months

  • Mean change in inflammatory response in peri-implant crevicular fluid (PICF)

    0-6 months

  • +3 more secondary outcomes

Study Arms (2)

Laser treatment

EXPERIMENTAL

Laser treatment with diode laser 970nm and settings 1.2W in intervals of max 20s, until satisfactory removal of diseased epithelium and granulation tissue.

Device: Laser treatmentBehavioral: Oral hygiene instructions

Mucosal flap surgery

ACTIVE COMPARATOR

Conventional mucosal flap surgery of affected dental implant.

Procedure: Mucosal flap surgeryBehavioral: Oral hygiene instructions

Interventions

Laser treatmentDEVICE

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.

Laser treatment
Mucosal flap surgeryPROCEDURE

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.

Mucosal flap surgery
Oral hygiene instructionsBEHAVIORAL

Oral hygiene instructions of how to clean around dental implants as per individual needs in terms of access to clean and fine motor skills.

Laser treatmentMucosal flap surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Danakliniken Specialist Dentistry

Danderyd, Stockholm County, 18231, Sweden

Location

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

Huddinge, Stockholm County, 14152, Sweden

Location

MeSH Terms

Conditions

Peri-Implantitis

Interventions

Laser Therapy

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsAblation TechniquesSurgical Procedures, Operative

Study Officials

  • Annsofi Johannsen

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Masking for the assessors of microbial, immunological and radiographic analyses.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

October 16, 2019

First Posted

January 30, 2020

Study Start

September 25, 2019

Primary Completion

June 21, 2022

Study Completion

June 21, 2022

Last Updated

November 18, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations

SE(2)