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Treatment of Periodontitis With Er:YAG Laser

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ClinicalTrials.gov Identifier: NCT03628872
Recruitment Status : Completed
First Posted : August 14, 2018
Last Update Posted : October 17, 2019
Sponsor:
Information provided by (Responsible Party):
Philip Y. Kang, Columbia University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Generalized Moderate Chronic Periodontitis Generalized Severe Chronic Periodontitis Periodontal Diseases Procedure: Scaling and root planing Device: Er:YAG Laser Device: Hand instruments Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Examiner was blinded to treatment allocation during baseline and at the 3 month re-evaluation
Primary Purpose: Treatment
Official Title: Treatment of Periodontitis Utilizing Two Different Modalities: Erbium-doped Yttrium Aluminium Garnet (Er:YAG) Laser and Conventional Mechanical Debridement
Actual Study Start Date : March 2, 2018
Actual Primary Completion Date : May 1, 2019
Actual Study Completion Date : June 1, 2019

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 Name: 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 Name: 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 Name: 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 Name: Erbium-doped Yttrium Aluminium Garnet Laser




Primary Outcome Measures :
  1. Change in Clinical Attachment Level (CAL) [ Time Frame: Recorded at baseline and 3 months after treatment ]
    Calculated based on distance from CEJ to gingival margin and the pocket depth (site specific measurement)

  2. Change in Pocket Depth (PD) [ Time Frame: Recorded at baseline and 3 months after treatment ]
    Measured at 6 sites per tooth in millimeters (mm) (site specific measurement)


Secondary Outcome Measures :
  1. Change in Plaque Index (PI) [ Time Frame: Recorded at baseline and 3 months after treatment ]
    Plaque and calculus accumulation on tooth surfaces (site specific measurement)

  2. Difference in timing [ Time Frame: During the time both therapies are performed ]
    Timing spent performing the 2 different types of therapy

  3. Differences in sensitivity [ Time Frame: VAS completed at baseline, 1 month follow up and 3 months re-evaluation ]
    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.

  4. Change in Bleeding on Probing (BoP) [ Time Frame: Recorded at baseline and 3 months after treatment ]
    Bleeding after probing the pocket (site specific measurement)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03628872


Locations
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United States, New York
Columbia University College of Dental Medicine
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Investigators
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Principal Investigator: Philip Kang, DDS, MS Columbia University
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Responsible Party: Philip Y. Kang, Assistant Professor of Dental Medicine (Periodontist) at the Columbia University Medical Center, College of Dental Medicine, Columbia University
ClinicalTrials.gov Identifier: NCT03628872    
Other Study ID Numbers: AAAR6077
First Posted: August 14, 2018    Key Record Dates
Last Update Posted: October 17, 2019
Last Verified: October 2019

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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
Keywords provided by Philip Y. Kang, Columbia University:
Scaling and root planing
Laser scaling
Additional relevant MeSH terms:
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Periodontitis
Chronic Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases