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

An Evaluation Of Effectiveness Of A Combined Er:YAG And Nd:YAG Laser Protocol For Treatment Of Peri-Implantitis: A Randomized Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Peri-Implantitis
• Intervention / Treatment: Device: Lightwalker Laser (Fotona); Other: standard

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 62
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Luis Monteiro, DMD, PhD; Phone Number: +351 919120226; Email: luis.monteiro@iucs.cespu.pt

Study Locations

• Portugal
  • Porto, Portugal, 4585-116
    • Recruiting
    • Instituto Universitário de Ciências da Saude, CESPU
    • Contact: Luis Monteiro; Phone Number: +351 919120226; Email: luis.monteiro@iucs.cespu.pt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: 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.; Other Names: TwinLight periimplantitis
Active Comparator: Control; Standard periimplantitis treatment will be conducted in the control group.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of participants with treatment success	Treatment success defined as implant survival with the absence of peri-implant probing depths (PD) greater than 5 mm with concomitant bleeding/suppuration and absence of progression of peri-implant bone loss.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plaque index	(PI)	1 month
Plaque index	(PI)	3 months
Plaque index	(PI)	6 months
Plaque index	(PI)	12 months
Bleeding on probing	(BOP) evaluated as present if bleeding was evident within 30 s after probing, or absent, if no bleeding was noticed within 30 s after probing.	1 month
Bleeding on probing	evaluated as present if bleeding was evident within 30 s after probing, or absent, if no bleeding was noticed within 30 s after probing.	3 months
Bleeding on probing	evaluated as present if bleeding was evident within 30 s after probing, or absent, if no bleeding was noticed within 30 s after probing.	6 months
Bleeding on probing	evaluated as present if bleeding was evident within 30 s after probing, or absent, if no bleeding was noticed within 30 s after probing.	12 months
Probing depth	measured from the mucosal margin to the bottom of the pocket.	1 month
Probing depth	measured from the mucosal margin to the bottom of the pocket.	3 months
Probing depth	measured from the mucosal margin to the bottom of the pocket.	6 months
Probing depth	measured from the mucosal margin to the bottom of the pocket.	12 months
Mucosal recession	measured from the mucosal margin to the bottom of the pocket.	1 month
Mucosal recession	measured from the mucosal margin to the bottom of the pocket.	3 months
Mucosal recession	measured from the mucosal margin to the bottom of the pocket.	6 months
Mucosal recession	measured from the mucosal margin to the bottom of the pocket.	12 months
Clinical attachment level gain	Difference in clinical attachment level at baseline and follow up.	1 month
Clinical attachment level gain	Difference in clinical attachment level at baseline and follow up.	3 months
Clinical attachment level gain	Difference in clinical attachment level at baseline and follow up.	6 months
Clinical attachment level gain	Difference in clinical attachment level at baseline and follow up.	12 months
Quality of life questionnaire	Oral Health Impact Profile-14 on the scale from 0 to 56 with higher scores indicating a poorer oral health-related quality of life.	0 months
Quality of life questionnaire	Oral Health Impact Profile-14 on the scale from 0 to 56 with higher scores indicating a poorer oral health-related quality of life.	1 month
Quality of life questionnaire	Oral Health Impact Profile-14 on the scale from 0 to 56 with higher scores indicating a poorer oral health-related quality of life.	3 months
Quality of life questionnaire	Oral Health Impact Profile-14 on the scale from 0 to 56 with higher scores indicating a poorer oral health-related quality of life.	6 months
Quality of life questionnaire	Oral Health Impact Profile-14 on the scale from 0 to 56 with higher scores indicating a poorer oral health-related quality of life.	12 months

Collaborators and Investigators

• Sponsor: Luis Monteiro
• Investigators: Principal Investigator: Luis Monteiro, DMD, PhD, Instituto Universitário de Ciências da Saude, CESPU

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2018
• Primary Completion (Estimated): December 1, 2023
• Study Completion (Estimated): May 1, 2024

Study Registration Dates

• First Submitted: January 25, 2019
• First Submitted That Met QC Criteria: January 25, 2019
• First Posted (Actual): January 28, 2019

Study Record Updates

• Last Update Posted (Actual): September 1, 2023
• Last Update Submitted That Met QC Criteria: August 31, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: randomized controlled trial; laser; Er:YAG; periimplantitis; Nd:YAG
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Peri-Implantitis
• Other Study ID Numbers: 26/CE-IUCS/2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No