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Treatment of Periodontitis With Er:YAG Laser

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Scaling and root planing
Er:YAG Laser
Hand instruments
Sponsored by
Columbia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Generalized Moderate Chronic Periodontitis focused on measuring Scaling and root planing, Laser scaling

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Columbia University College of Dental Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Scaling and Root Planing with Hand Instruments

Er:YAG Laser Scaling

Arm Description

Patients will undergo scaling and root planing with hand instruments (half of their mouth, following a split-mouth design)

Patients will undergo scaling and root planing with Er:YAG Laser in the untreated half of their mouth.

Outcomes

Primary Outcome Measures

Change in Clinical Attachment Level (CAL)
Calculated based on distance from CEJ to gingival margin and the pocket depth (site specific measurement)
Change in Pocket Depth (PD)
Measured at 6 sites per tooth in millimeters (mm) (site specific measurement)

Secondary Outcome Measures

Change in Plaque Index (PI)
Plaque and calculus accumulation on tooth surfaces (site specific measurement)
Difference in timing
Timing spent performing the 2 different types of therapy
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.
Change in Bleeding on Probing (BoP)
Bleeding after probing the pocket (site specific measurement)

Full Information

First Posted
August 8, 2018
Last Updated
October 15, 2019
Sponsor
Columbia University
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1. Study Identification

Unique Protocol Identification Number
NCT03628872
Brief Title
Treatment of Periodontitis With Er:YAG Laser
Official Title
Treatment of Periodontitis Utilizing Two Different Modalities: Erbium-doped Yttrium Aluminium Garnet (Er:YAG) Laser and Conventional Mechanical Debridement
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
March 2, 2018 (Actual)
Primary Completion Date
May 1, 2019 (Actual)
Study Completion Date
June 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Columbia University

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Generalized Moderate Chronic Periodontitis, Generalized Severe Chronic Periodontitis, Periodontal Diseases
Keywords
Scaling and root planing, Laser scaling

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Examiner was blinded to treatment allocation during baseline and at the 3 month re-evaluation
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Scaling and Root Planing with Hand Instruments
Arm Type
Active Comparator
Arm Description
Patients will undergo scaling and root planing with hand instruments (half of their mouth, following a split-mouth design)
Arm Title
Er:YAG Laser Scaling
Arm Type
Experimental
Arm Description
Patients will undergo scaling and root planing with Er:YAG Laser in the untreated half of their mouth.
Intervention Type
Procedure
Intervention Name(s)
Scaling and root planing
Other Intervention Name(s)
Deep cleaning
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Er:YAG Laser
Other Intervention Name(s)
Erbium-doped Yttrium Aluminium Garnet Laser
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Hand instruments
Other Intervention Name(s)
Hand instrumentation
Intervention Description
11/12 and 13/14 gracey, 4R/4L curette and sickle - standard of care choices for performing scaling and root planing.
Primary Outcome Measure Information:
Title
Change in Clinical Attachment Level (CAL)
Description
Calculated based on distance from CEJ to gingival margin and the pocket depth (site specific measurement)
Time Frame
Recorded at baseline and 3 months after treatment
Title
Change in Pocket Depth (PD)
Description
Measured at 6 sites per tooth in millimeters (mm) (site specific measurement)
Time Frame
Recorded at baseline and 3 months after treatment
Secondary Outcome Measure Information:
Title
Change in Plaque Index (PI)
Description
Plaque and calculus accumulation on tooth surfaces (site specific measurement)
Time Frame
Recorded at baseline and 3 months after treatment
Title
Difference in timing
Description
Timing spent performing the 2 different types of therapy
Time Frame
During the time both therapies are performed
Title
Differences in sensitivity
Description
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.
Time Frame
VAS completed at baseline, 1 month follow up and 3 months re-evaluation
Title
Change in Bleeding on Probing (BoP)
Description
Bleeding after probing the pocket (site specific measurement)
Time Frame
Recorded at baseline and 3 months after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philip Kang, DDS, MS
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University College of Dental Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Treatment of Periodontitis With Er:YAG Laser

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