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

Peri-Implantitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03819075
• Other study ID #: 26/CE-IUCS/2018
• Status: Recruiting
• Phase: N/A
• Start date: March 3, 2018
• Est. completion date: May 2024

Study information

• Verified date: August 2023
• Source: Cooperativa de Ensino Superior, Politécnico e Universitário
• Contact: Luis Monteiro, DMD, PhD
• Phone: +351 919120226
• Email: luis.monteiro[@]iucs.cespu.pt
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 62
• Est. completion date: May 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Peri-Implantitis

Intervention

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:
• 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.

Locations

Country	Name	City	State
Portugal	Instituto Universitário de Ciências da Saude, CESPU	Porto

Sponsors (1)

Lead Sponsor	Collaborator
Luis Monteiro

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Plaque index	(PI)	1 month
Secondary	Plaque index	(PI)	3 months
Secondary	Plaque index	(PI)	6 months
Secondary	Plaque index	(PI)	12 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Probing depth	measured from the mucosal margin to the bottom of the pocket.	1 month
Secondary	Probing depth	measured from the mucosal margin to the bottom of the pocket.	3 months
Secondary	Probing depth	measured from the mucosal margin to the bottom of the pocket.	6 months
Secondary	Probing depth	measured from the mucosal margin to the bottom of the pocket.	12 months
Secondary	Mucosal recession	measured from the mucosal margin to the bottom of the pocket.	1 month
Secondary	Mucosal recession	measured from the mucosal margin to the bottom of the pocket.	3 months
Secondary	Mucosal recession	measured from the mucosal margin to the bottom of the pocket.	6 months
Secondary	Mucosal recession	measured from the mucosal margin to the bottom of the pocket.	12 months
Secondary	Clinical attachment level gain	Difference in clinical attachment level at baseline and follow up.	1 month
Secondary	Clinical attachment level gain	Difference in clinical attachment level at baseline and follow up.	3 months
Secondary	Clinical attachment level gain	Difference in clinical attachment level at baseline and follow up.	6 months
Secondary	Clinical attachment level gain	Difference in clinical attachment level at baseline and follow up.	12 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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