Treatment of Periodontitis With Er:YAG Laser

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

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.

Study Overview

• Status: Completed
• Conditions: Periodontal Diseases; Generalized Moderate Chronic Periodontitis; Generalized Severe Chronic Periodontitis
• Intervention / Treatment: Procedure: Scaling and root planing; Device: Hand instruments; Device: Er:YAG Laser

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • Columbia University College of Dental Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Scaling and Root Planing with Hand Instruments; Patients will undergo scaling and root planing with hand instruments (half of their mouth, following a split-mouth design)	Procedure: Scaling and root planing; 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.; Other Names: Deep cleaning; Device: Hand instruments; 11/12 and 13/14 gracey, 4R/4L curette and sickle - standard of care choices for performing scaling and root planing.; Other Names: Hand instrumentation
Experimental: Er:YAG Laser Scaling; Patients will undergo scaling and root planing with Er:YAG Laser in the untreated half of their mouth.	Procedure: Scaling and root planing; 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.; Other Names: Deep cleaning; Device: Er:YAG Laser; 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.; Other Names: Erbium-doped Yttrium Aluminium Garnet Laser

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Columbia University
• Investigators: Principal Investigator: Philip Kang, DDS, MS, Columbia University

Study record dates

Study Major Dates

• Study Start (Actual): March 2, 2018
• Primary Completion (Actual): May 1, 2019
• Study Completion (Actual): June 1, 2019

Study Registration Dates

• First Submitted: August 8, 2018
• First Submitted That Met QC Criteria: August 10, 2018
• First Posted (Actual): August 14, 2018

Study Record Updates

• Last Update Posted (Actual): October 17, 2019
• Last Update Submitted That Met QC Criteria: October 15, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: Scaling and root planing; Laser scaling
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Periodontitis; Periodontal Diseases; Chronic Periodontitis
• Other Study ID Numbers: AAAR6077

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No