Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Treatment of Periodontitis With Er:YAG Laser

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE August 8, 2018
First Posted Date  ICMJE August 14, 2018
Last Update Posted Date October 17, 2019
Actual Study Start Date  ICMJE March 2, 2018
Actual Primary Completion Date May 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 15, 2019)
  • 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)
  • 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)
Original Primary Outcome Measures  ICMJE
 (submitted: August 10, 2018)
  • Change in Clinical Attachment Level (CAL) [ Time Frame: Baseline, 3 months ]
    When the gingival margin is coronal to the cemento-enamel junction (CEJ), the CAL is calculated by subtracting the gingival margin level from the probing depths.
  • Change in Probing Pocket Depth (PPD) [ Time Frame: Baseline, 3 months ]
    Measured at 6 sites per tooth in millimeters (mm). Depths greater than 3 mm can be associated with "attachment loss" of the tooth to the surrounding alveolar bone, which is a characteristic found in periodontitis.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 15, 2019)
  • 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)
  • Difference in timing [ Time Frame: During the time both therapies are performed ]
    Timing spent performing the 2 different types of therapy
  • 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.
  • Change in Bleeding on Probing (BoP) [ Time Frame: Recorded at baseline and 3 months after treatment ]
    Bleeding after probing the pocket (site specific measurement)
Original Secondary Outcome Measures  ICMJE
 (submitted: August 10, 2018)
  • Change in Gingival Recession (GR) [ Time Frame: Baseline, 3 months ]
    the oral exposure of the root surface due to a displacement of the gingival margin apical to the cement-enamel junction, measured in mm.
  • Difference in timing [ Time Frame: Baseline only (when the therapies are being rendered) ]
    Timing spent performing the 2 different types of therapy
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treatment of Periodontitis With Er:YAG Laser
Official Title  ICMJE Treatment of Periodontitis Utilizing Two Different Modalities: Erbium-doped Yttrium Aluminium Garnet (Er:YAG) Laser and Conventional Mechanical Debridement
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Generalized Moderate Chronic Periodontitis
  • Generalized Severe Chronic Periodontitis
  • Periodontal Diseases
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • 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)
    Interventions:
    • Procedure: Scaling and root planing
    • Device: Hand instruments
  • Experimental: Er:YAG Laser Scaling
    Patients will undergo scaling and root planing with Er:YAG Laser in the untreated half of their mouth.
    Interventions:
    • Procedure: Scaling and root planing
    • Device: Er:YAG Laser
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 15, 2019)
26
Original Estimated Enrollment  ICMJE
 (submitted: August 10, 2018)
24
Actual Study Completion Date  ICMJE June 1, 2019
Actual Primary Completion Date May 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03628872
Other Study ID Numbers  ICMJE AAAR6077
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Philip Y. Kang, Columbia University
Study Sponsor  ICMJE Columbia University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Philip Kang, DDS, MS Columbia University
PRS Account Columbia University
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP