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Clinical Evaluation of Laser Therapy Used as an Adjunct to Non-Surgical Treatment of Gum Disease

Primary Purpose

Periodontitis Chronic Generalized Moderate, Periodontitis Chronic Generalized Severe

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Laser Therapy
Non-surgical Scaling and Root Planing
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontitis Chronic Generalized Moderate focused on measuring Laser Therapy, Non-surgical periodontal therapy, Scaling and root planing

Eligibility Criteria

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

Inclusion Criteria:

  • Age 18 years old or older (male or female)
  • Healthy without systemic diseases that may adversely effect healing
  • Not pregnant and no current plans to become pregnant
  • No periodontal treatment in the previous 12 months
  • No systemic antibiotic therapy in the previous 6 months
  • At least two quadrants with periodontitis (ideally opposite side same jaw)
  • Each quadrant must have two or more sites with probing pocket depths ≥ 5mm
  • Each quadrant should include interproximal intrabony defect(s)

Exclusion criteria:

  • Any systemic disease, medication, or habit known to adversely influence bone metabolism and/or wound healing:
  • Poorly controlled diabetes (HbA1c > 7%)
  • History of bisphosphonate medications
  • History of radiation therapy affecting the proposed treatment site(s)
  • History of immunosuppressive medications (e.g. corticosteroids)
  • History of tobacco use (current or past tobacco use within the past 1 year)
  • Immune compromise caused by disease, treatment or other condition
  • Recent history of periodontal surgery (within the previous 2 years)
  • Recent history of scaling and root planing (within the previous 12 months)
  • Any condition that contraindicates periodontal therapy including surgery

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    SRP + Adjunctive Laser Therapy

    SRP alone

    Arm Description

    Laser therapy used as an adjunct to scaling and root planing

    Scaling and root planing used as conventional non-surgical periodontal therapy

    Outcomes

    Primary Outcome Measures

    Probing Pocket Depth
    This is a measure from base of pocket to gingival margin.
    Sites That Bleed on Probing
    Percentage of sites that bleed in response to probing. Bleeding observed within 30 seconds from pocket/sulcus following periodontal probe measurement.
    Gingival Recession
    Measure of gingival recession following treatment. This is a measure of the gingival margin from the cement-enamel junction.
    Clinical Attachment Level
    Periodontal clinical attachment level following treatment. This is a calculation (clinical attachment level = probing pocket depth + gingival recession).

    Secondary Outcome Measures

    Periodontal Microbiome
    Assess changes in periodontal microbiome using DNA sequencing
    Patient Reported Outcomes: VAS Questionnaire
    Measure patient reported pain (0-100), comfort (0-100), sensitivity (0-100) and satisfaction (0-100) using VAS questionnaire, with lower values indicating better outcome for pain and sensitivity and higher values indicating better outcome for comfort and satisfaction.

    Full Information

    First Posted
    July 18, 2019
    Last Updated
    February 12, 2021
    Sponsor
    University of California, Los Angeles
    Collaborators
    Biolase Inc
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04027686
    Brief Title
    Clinical Evaluation of Laser Therapy Used as an Adjunct to Non-Surgical Treatment of Gum Disease
    Official Title
    Clinical Evaluation of WaterLase (iPlus) Laser Therapy Used as an Adjunct to Non-Surgical Treatment of Chronic Periodontitis: A Randomized, Controlled, Split-Mouth Clinical Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2017 (Actual)
    Primary Completion Date
    December 2019 (Actual)
    Study Completion Date
    December 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of California, Los Angeles
    Collaborators
    Biolase Inc

    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.
    Yes
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The use of lasers to treat various problems in dentistry is growing as it has in medicine. One application is the use of lasers to treat periodontal disease. It has been suggested that the laser may reduce the need for surgical treatment by reducing pockets. The goal of this study is to evaluate the effectiveness of laser treatment for periodontal disease. Laser therapy will be used in addition to traditional non-surgical scaling and root planing (deep cleaning). The information obtained from this study will provide an objective assessment of adjunctive laser therapy compared to conventional periodontal therapy and will attempt to show the benefits, if any, lasers can provide in the treatment of chronic periodontal disease.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Periodontitis Chronic Generalized Moderate, Periodontitis Chronic Generalized Severe
    Keywords
    Laser Therapy, Non-surgical periodontal therapy, Scaling and root planing

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Randomized, Controlled, Split-mouth
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    23 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    SRP + Adjunctive Laser Therapy
    Arm Type
    Experimental
    Arm Description
    Laser therapy used as an adjunct to scaling and root planing
    Arm Title
    SRP alone
    Arm Type
    Active Comparator
    Arm Description
    Scaling and root planing used as conventional non-surgical periodontal therapy
    Intervention Type
    Device
    Intervention Name(s)
    Laser Therapy
    Intervention Description
    Adjunctive application of laser therapy in the periodontal pocket
    Intervention Type
    Procedure
    Intervention Name(s)
    Non-surgical Scaling and Root Planing
    Intervention Description
    Scaling to remove calculus deposits and root planing to smooth root surfaces
    Primary Outcome Measure Information:
    Title
    Probing Pocket Depth
    Description
    This is a measure from base of pocket to gingival margin.
    Time Frame
    12 months
    Title
    Sites That Bleed on Probing
    Description
    Percentage of sites that bleed in response to probing. Bleeding observed within 30 seconds from pocket/sulcus following periodontal probe measurement.
    Time Frame
    12 months
    Title
    Gingival Recession
    Description
    Measure of gingival recession following treatment. This is a measure of the gingival margin from the cement-enamel junction.
    Time Frame
    12 months
    Title
    Clinical Attachment Level
    Description
    Periodontal clinical attachment level following treatment. This is a calculation (clinical attachment level = probing pocket depth + gingival recession).
    Time Frame
    12 months
    Secondary Outcome Measure Information:
    Title
    Periodontal Microbiome
    Description
    Assess changes in periodontal microbiome using DNA sequencing
    Time Frame
    12 months
    Title
    Patient Reported Outcomes: VAS Questionnaire
    Description
    Measure patient reported pain (0-100), comfort (0-100), sensitivity (0-100) and satisfaction (0-100) using VAS questionnaire, with lower values indicating better outcome for pain and sensitivity and higher values indicating better outcome for comfort and satisfaction.
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Age 18 years old or older (male or female) Healthy without systemic diseases that may adversely effect healing Not pregnant and no current plans to become pregnant No periodontal treatment in the previous 12 months No systemic antibiotic therapy in the previous 6 months At least two quadrants with periodontitis (ideally opposite side same jaw) Each quadrant must have two or more sites with probing pocket depths ≥ 5mm Each quadrant should include interproximal intrabony defect(s) Exclusion criteria: Any systemic disease, medication, or habit known to adversely influence bone metabolism and/or wound healing: Poorly controlled diabetes (HbA1c > 7%) History of bisphosphonate medications History of radiation therapy affecting the proposed treatment site(s) History of immunosuppressive medications (e.g. corticosteroids) History of tobacco use (current or past tobacco use within the past 1 year) Immune compromise caused by disease, treatment or other condition Recent history of periodontal surgery (within the previous 2 years) Recent history of scaling and root planing (within the previous 12 months) Any condition that contraindicates periodontal therapy including surgery
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Perry R Klokkevold, DDS, MS
    Organizational Affiliation
    UCLA School of Dentistry, Section of Periodontics
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Clinical Evaluation of Laser Therapy Used as an Adjunct to Non-Surgical Treatment of Gum Disease

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