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

Study Overview
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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.

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

Conditions
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Peri-Implantitis

Intervention / Treatment
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* Device: Lightwalker Laser (Fotona)
* Other: standard


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Two groups; laser and control
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Laser<br>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)<br>* 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.<br>* Other names: TwinLight periimplantitis;|
| Active Comparator: Control<br>Standard periimplantitis treatment will be conducted in the control group. | Other: standard<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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periimplantitis, laser, Er:YAG, Nd:YAG, randomized controlled trial