Peri-implantitis Treatment: Clinical Results of Conventional Treatment vs. the Addition of Biolase

Study Overview
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Brief Summary
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The purpose of the study is to observe the effects of two commonly utilized treatment modalities to treat peri-implantitis and to compare the results. The first method of treatment is debridement with curettes and ultrasonic scalers and it represents the traditional approach in the treatment of peri-implantitis. The second method of treatment involves the use of the Biolase laser in addition to the traditional approach of debriding with curettes and ultrasonic scalers. No studies exist comparing these two approaches, and this will serve as a pilot study to explore possible differences. Our research hypothesis is that the addition of Er;Cr;YSGG laser is likely to be more effective in removing the microbiota from a rough implant surface, and that this will manifest with improved clinical parameters in subjects that receive this method of treatment.

Detailed Description
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This clinical study will involve 26 human subjects pre-screened at Columbia University. The patient will have at least one implant presenting with early to moderate peri-implantitis. Peri-implantitis has been defined as an implant restoration with inflamed bleeding gingiva, probing depths around the implant of 5-8mm, bone loss and exposure of threads around the implant (limited to one-third of the threads exposed). The purpose of this study is to determine the benefits of treating peri-implantitis with a closed laser approach known as the Repair Protocol using an Er,Cr:YSGG laser compared with traditional non-surgical therapy. Each subject, when determined to fall under the parameters of the study for peri-implantitis, will be randomly assigned to one of two groups: the test Er,Cr:YSGG laser group or the control group. The study will constitute a human double-blind randomized clinical trial in which both examiners and patients will be blinded to the treatment. In order to ensure the blinding of the patients, the laser will be applied to all implants, although the it will not be activated in the control group. The therapist will be the same person throughout the study while the examiners will be calibrated. The two groups that will constitute the study and the procedures that will be applied are: Experimental: Scaling and root planning with an ultrasonic or piezoelectric instrument and hand instrumentation with hand instruments. No prosthetic components will be removed . Application of laser therapy following the specifics of the company. Control: Scaling and root planning with an ultrasonic or piezoelectric instrument and hand instrumentation with hand instruments. A sham, inactivated laser, treatment will be delivered. After the treatment, the patients will be followed-up after 1 week, 3, 6 and 9 months. Periapical X-rays will be taken at baseline and 9 months follow-up appointments. Data to be collected include: Primary outcome measures will include: presence of bleeding on probing, probing depth, and the progression of bone loss around the implant, as measured with bone sounding under local anesthesia and radiographically with the aid of a stent. Secondary outcome measures will include: Gingival index (GI), Plaque Index, mobility, and suppuration.

Official Title
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Treatment of Peri-implantitis: Clinical Comparison Between Conventional Treatment Versus Conventional Plus Biolase Laser Treatment as a Co-adjuvant

Conditions
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Peri-Implantitis

Intervention / Treatment
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* Device: Er,Cr:YSGG laser
* Procedure: Scaling
* Device: Inactive Er,Cr:YSGG


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Presence of at least one implant presenting with early to moderate peri-implantitis Peri-implantitis defined as an implant restoration with inflamed bleeding gingiva, probing depths around the implant of 5-8mm, bone loss and exposure of threads around the implant (limited to one-third of the threads exposed). Medically healthy non-smokers with no previous periodontal treatment other than routine maintenance Patients with diabetes were only included if they reported an HbA1C of 7% or less within the past 3 months Exclusion Criteria: Mobility of the implant Peri-implantitis treatment rendered in the last 3 months

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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Accepts Healthy Volunteers

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: Double blind randomized clinical trial
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Scaling and use of inactive Er,Cr:YSGG<br>Scaling and debridement with hand scalers and ultrasonic unit together with the application of the Er,Cr:YSGG laser in an inactive fashion | Procedure: Scaling<br>* Scaling and debridement of the implant surface with hand scalers and curettes and an ultrasonic scaling unit (Cavitron -Dentsply Sirona)<br>Device: Inactive Er,Cr:YSGG<br>* Er,Cr:YSGG laser (inactive form - sham procedure) applied to the surface of the implant<br>|
| Experimental: Scaling and use of active Er,Cr:YSGG<br>Scaling and debridement with hand scalers and ultrasonic unit together with the application of the Er,Cr:YSGG laser in an active fashion | Device: Er,Cr:YSGG laser<br>* Application of Er,Cr:YSGG in peri-implantitis cases as a coadjutant has shown reduction in the pocket depths and bleeding on probing<br>* Other names: Biolase (Biolase, Inc);Procedure: Scaling<br>* Scaling and debridement of the implant surface with hand scalers and curettes and an ultrasonic scaling unit (Cavitron -Dentsply Sirona)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Probing depth | Recorded at 6 sites per implant (mesio-buccal and lingual, mid-buccal and lingual, disto-buccal and lingual). Measured in mm with a manual periodontal probe (UNC-15) | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression of bone loss around the implant | Measured on calibrated (taken with a positioning device) peri-apical X-rays. Distance from the platform of the implant to the crest of the bone in the mesial and distal sites | 9 months | 
| Presence of bleeding on probing | Recorded at 6 sites per implant (mesio-buccal and lingual, mid-buccal and lingual, disto-buccal and lingual). Dichotomic | 9 months | 
| Presence of suppuration on probing | Recorded at 6 sites per implant (mesio-buccal and lingual, mid-buccal and lingual, disto-buccal and lingual). Dichotomic | 9 months | 
| Presence of plaque | Recorded at 6 sites per implant (mesio-buccal and lingual, mid-buccal and lingual, disto-buccal and lingual). Dichotomic | 9 months | 
| Mobility | Stability of the implant. Detected manually. Dichotomic. | 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Biolase, peri-implantitis, laser treatment, Er,Cr:YSGG