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

Not Applicable

Recruiting

• Conditions: Peri-Implantitis
• Interventions: Device: Lightwalker Laser (Fotona); Other: standard

• Registration Number: NCT03819075
• Lead Sponsor: Luis Monteiro

Brief Summary

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

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 Timeline

• Study Start: 2018-03-03
• Study First Submitted: 2019-01-25
• Study First Submitted QC: 2019-01-25
• Study First Posted: 2019-01-28
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-31
• Last Update Posted: 2023-09-01
• Primary Completion: 2023-12
• Study Completion: 2024-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 62

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Laser	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.
Control	standard	Standard periimplantitis treatment will be conducted in the control group.

Primary Outcome Measures

Name	Time	Method
Proportion of participants with treatment success	6 months	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Instituto Universitário de Ciências da Saude, CESPU; 🇵🇹 Porto, Portugal