Combined Er:YAG And Nd:YAG Laser Protocol For Treatment Of Peri-Implantitis

NCT ID: NCT03819075

Last Updated: 2023-09-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-03

Study Completion Date

2024-05-31

Brief Summary

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A laser treatment for periimplantitis using two different wavelengths (Er:YAG and Nd:YAG) will be compared to standard treatment in a randomized clinical trial.

Detailed Description

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The general aim of this study is to evaluate the clinical outcome of the treatment of peri-implantitis using a combination of a Er:YAG and Nd:YAG laser protocol or using a conventional mechanical treatment in patients with a diagnosis of peri-implantitis.

Conditions

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Peri-Implantitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Two groups; laser and control
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Clinical measurements will be performed by an evaluator unaware of group assignment.

Study Groups

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Laser

For the laser group we will use a Lightwalker Laser (Fotona) with a Er:YAG 2940 nm and Nd:YAG 1064 nm wavelengths units.

Group Type EXPERIMENTAL

Lightwalker Laser (Fotona)

Intervention Type DEVICE

For the laser group we will use a Lightwalker Laser (Fotona) with a Er:YAG 2940 nm and Nd:YAG 1064 nm wavelengths units. The laser protocol will follow the instructions of the manufacturer (TwinLight protocol) and consists of degranulation of necrotic soft tissue and bone, implant surface disinfection and creating spot bleeding in bone with Er:YAG and deep disinfection and biomodulation with Nd:YAG.

Control

Standard periimplantitis treatment will be conducted in the control group.

Group Type ACTIVE_COMPARATOR

standard

Intervention Type OTHER

Granulation tissue elimination, mechanical instrumentation of the implant surface and curettage of intraosseous or supracrestally bone defects will be accomplished using plastic curets, under irrigation with sterile saline solution. Cotton pellets soaked in sterile saline solution will be use to clean debris and remains of removed tissue.

Interventions

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Lightwalker Laser (Fotona)

For the laser group we will use a Lightwalker Laser (Fotona) with a Er:YAG 2940 nm and Nd:YAG 1064 nm wavelengths units. The laser protocol will follow the instructions of the manufacturer (TwinLight protocol) and consists of degranulation of necrotic soft tissue and bone, implant surface disinfection and creating spot bleeding in bone with Er:YAG and deep disinfection and biomodulation with Nd:YAG.

Intervention Type DEVICE

standard

Granulation tissue elimination, mechanical instrumentation of the implant surface and curettage of intraosseous or supracrestally bone defects will be accomplished using plastic curets, under irrigation with sterile saline solution. Cotton pellets soaked in sterile saline solution will be use to clean debris and remains of removed tissue.

Intervention Type OTHER

Other Intervention Names

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TwinLight periimplantitis

Eligibility Criteria

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Inclusion Criteria

* at least one implant with peri-implantitis
* no serious mobility of the implants
* written informed consent of the voluntary participant in the study
* availability of participant for control visits for a follow-up of at least 12 months without interruptions

Exclusion Criteria

* serious systematic disease
* pregnancy
* current use of photosensitive drugs, bisphosphonate medication or antibiotics
* patients who do not want to follow post treatment recommendation of oral hygiene and follow-up visits
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Luis Monteiro

OTHER

Sponsor Role lead

Responsible Party

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Luis Monteiro

DMD, Phd, Auxiliar Professor at the IUCS in Periodontal Surgical Clinic, Oral Pathology and Biopathology

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Luis Monteiro, DMD, PhD

Role: PRINCIPAL_INVESTIGATOR

Instituto Universitário de Ciências da Saude, CESPU

Locations

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Instituto Universitário de Ciências da Saude, CESPU

Porto, , Portugal

Site Status RECRUITING

Countries

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Portugal

Central Contacts

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Luis Monteiro, DMD, PhD

Role: CONTACT

+351 919120226

Facility Contacts

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Luis Monteiro

Role: primary

+351 919120226

Other Identifiers

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26/CE-IUCS/2018

Identifier Type: -

Identifier Source: org_study_id

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