Treatment of Periodontitis With Er:YAG Laser

Study Overview
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Brief Summary
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The purpose of this research project is to gain information on the best and most comfortable way to treat the periodontal disease. The main objective is to compare the efficacy of conventional scaling and root planning compared to laser scaling for the non-surgical treatment of periodontal disease. Both therapies have shown to be effective and are regularly used in the dental clinic.

Detailed Description
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The study has been designed as a single blinded split-mouth randomized controlled clinical trial. Patients will be randomized prior to treatment, to which the examiner will be blinded. Clinical parameters will be recorded at baseline and 3 months after treatment has been completed. At the time of recruitment, inclusion/exclusion criteria checklist, informed consent and baseline measurements will be obtained and recorded. Medical history will be updated and radiographs will be reviewed or taken. During the second appointment, conventional scaling and root planing will be performed in the corresponding quadrant; during the third appointment, laser therapy will be conducted, 1 month after, during the forth appointment, a follow up (no measurements) will be scheduled with provider, and 3 months after scaling completion, measurements will be taken and periodontal maintenance performed. Patient will receive home care instructions at every visit and will fill out a visual analogue scale at baseline, 1 month and 3 month visit.

Official Title
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Treatment of Periodontitis Utilizing Two Different Modalities: Erbium-doped Yttrium Aluminium Garnet (Er:YAG) Laser and Conventional Mechanical Debridement

Conditions
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Generalized Moderate Chronic Periodontitis, Generalized Severe Chronic Periodontitis, Periodontal Diseases

Intervention / Treatment
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* Procedure: Scaling and root planing
* Device: Er:YAG Laser
* Device: Hand instruments


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed and dated Informed Consent Good general health Participants > 18 years of age Participants with > 20 teeth with 5 teeth, including at least 1 molar, in each quadrant of the mouth Participants with > 30% of the present teeth with Probing depths of > 4mm and Bleeding on Probing Non-smoker and former smokers (stopped smoking > 1 year) Participants that have not received any periodontal treatment in the past 3 months Exclusion Criteria: Participants with uncontrolled systemic diseases that could affect the treatment outcome such as Diabetes with HbA1c > 7.0 percent, rheumatoid arthritis, immunosuppression, HIV with detectable viral loads Participants requiring antibiotic prophylaxis for any cardiovascular conditions or after any transplant and/or replacement procedures Pregnant women Patients treated with systemic antibiotic therapy of periodontal/mechanical/local delivery therapy within 6 weeks prior to study entry and throughout the study duration Patients being chronically (two weeks or more) treated with any NSAIDs, steroids or any medications known to affect soft tissue condition (excluding treatment with Acetylsalicylic acid < 100 mg/day) Presence of orthodontic appliances, or any removable appliances that impinges on the tissues being assessed. Presence of soft or hard tissue tumors of the oral cavity The presence of any medical or psychiatric condition or any other condition that, in the opinion of the Investigator, could affect the successful participation of the patient in the study

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
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Scaling and Root Planing with Hand Instruments<br>Patients will undergo scaling and root planing with hand instruments (half of their mouth, following a split-mouth design) | Procedure: Scaling and root planing<br>* A non-surgical procedure that treats periodontal disease, sometimes called a deep cleaning, is considered the gold standard (standard of care) of treatment for patients with chronic periodontitis.<br>* Other names: Deep cleaning;Device: Hand instruments<br>* 11/12 and 13/14 gracey, 4R/4L curette and sickle - standard of care choices for performing scaling and root planing.<br>* Other names: Hand instrumentation;|
| Experimental: Er:YAG Laser Scaling<br>Patients will undergo scaling and root planing with Er:YAG Laser in the untreated half of their mouth. | Procedure: Scaling and root planing<br>* A non-surgical procedure that treats periodontal disease, sometimes called a deep cleaning, is considered the gold standard (standard of care) of treatment for patients with chronic periodontitis.<br>* Other names: Deep cleaning;Device: Er:YAG Laser<br>* This laser is intended to be used for dental surgery. The Er:YAG Laser emits an infrared beam which is readily absorbed by water contained by both hard and soft tissues of the human body. As a result, energy of the laser beam instantly vaporizes the water molecules in soft and hard tissues of the tooth and surrounding tissues causing the tissues to crumble away or resection of the soft tissues of gingival.<br>* Other names: Erbium-doped Yttrium Aluminium Garnet Laser;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Clinical Attachment Level (CAL) | Calculated based on distance from CEJ to gingival margin and the pocket depth (site specific measurement) | Recorded at baseline and 3 months after treatment | 
| Change in Pocket Depth (PD) | Measured at 6 sites per tooth in millimeters (mm) (site specific measurement) | Recorded at baseline and 3 months after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Plaque Index (PI) | Plaque and calculus accumulation on tooth surfaces (site specific measurement) | Recorded at baseline and 3 months after treatment | 
| Difference in timing | Timing spent performing the 2 different types of therapy | During the time both therapies are performed | 
| Differences in sensitivity | Visual Analogue Scale (VAS) from 0-10 and 4 multiple choice questions to assess patient's sensitivity and their level of satisfaction and preference towards both modalities. | VAS completed at baseline, 1 month follow up and 3 months re-evaluation | 
| Change in Bleeding on Probing (BoP) | Bleeding after probing the pocket (site specific measurement) | Recorded at baseline and 3 months after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Scaling and root planing, Laser scaling