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Effects of Scaling and Root Planing With and Without Er:YAG Laser in Chronic Periodontitis Patients

Primary Purpose

Chronic Periodontitis

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Scaling and Root Planing
Er:YAG Laser
Sponsored by
Tufts University School of Dental Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Periodontitis focused on measuring Scaling and Root Planing, Er:YAG

Eligibility Criteria

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

Inclusion Criteria:

  • Patients enrolled in the Post-Graduate Periodontology Clinic at Tufts University School of Dental Medicine (TUSDM)
  • Recent (within the past 30 days) diagnosis of moderate to severe chronic periodontitis in at least two quadrants according to the Armitage Classification
  • Have had full mouth and vertical bite-wing series of diagnostic radiographs exposed at TUSDM within 6 months preceding entry of the study as a standard of care
  • Have a treatment plan made by the original provider and certified by the PI based on the working diagnosis, presenting etiology, and the predicted therapeutic outcomes of the case (prognosis).
  • Each of the two selected quadrants should have at least 5 teeth including the canine, first premolar and second premolar in contact with at least one tooth that has ≥ 5 mms and ≤ 9 mms probing depths with bleeding on probing.

Exclusion Criteria:

  • Participants must not have had mechanical debridement or any other professional periodontal therapy within 6 months preceding entering the study
  • Participants with significant chronic oral soft tissue pathology (lichen planus, Benign Mucous Membrane Pemphigoid, Steven Johnson's Syndrome, Sjogren's Syndrome, etc.) which might affect host response to the presence of bacteria.
  • Participants with fixed appliances or partial dentures, to standardize the effect of the treatment since they are plaque retentive.
  • Participants who smoke tobacco
  • Participants who require prophylactic antibiotics prior to dental treatment
  • Participants who have taken systemic antibiotic medications within the previous 6 months
  • Participants with uncontrolled systemic conditions or disease such as diabetes and immunological disorders
  • Participants with known drug allergies or known adverse effects following the use of oral hygiene products.
  • Participants who are pregnant or lactating
  • Teeth with grade III mobility or teeth with hopeless prognosis indicated for extraction

Sites / Locations

  • Tufts University School of Dental MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Scaling and Root Planing

Scaling and Root Planing + Er:YAG Laser

Arm Description

Hand instruments + ultrasonic scaler PD, CAL, plaque index and gingival bleeding index will be measured at baseline, 6 weeks and 3 months. Microbial load will be measured at baseline and 3 months.

Er:YAG Laser, hand instruments + ultrasonic scaler PD, CAL, plaque index and gingival bleeding index will be measured at baseline, 6 weeks and 3 months. Microbial load will be measured at baseline and 3 months.

Outcomes

Primary Outcome Measures

Change in Probing Depth
Differences in pocket depth reduction between laser treatment and control groups will be analyzed with a linear mixed effects model. Four sites (mesiolingual, mesiobuccal, distolingual, and distobuccal) per tooth will be averaged and used in the linear mixed effects model. Normality of the data will be assessed graphically and with the Shapiro-Wilk test.
Change in Clinical Attachment Levels
Differences in attachment gain between laser treatment and control groups will be analyzed with a linear mixed effects model. Four sites (mesiolingual, mesiobuccal, distolingual, and distobuccal) per tooth will be averaged and used in the linear mixed effects model. Normality of the data will be assessed graphically and with the Shapiro-Wilk test.

Secondary Outcome Measures

Change in Gingival Bleeding Index
The gingival bleeding index (the number of bleeding sites divided by the total number of sites) will be calculated. Statistical significance between the two groups' gingival bleeding index will be determined with generalized estimating equations.
Change in Plaque Index
The plaque index (the number of surfaces with plaque divided by the total number of surfaces) will be calculated. Statistical significance between the two groups' plaque index will be determined with generalized estimating equations.
Change in microbial load, measured in Colony Forming Units (CFUs)
Microbial load will be measured by the total number of cultivable bacteria measured by total viable colony forming units (CFUs) on non-selective and selective media. Percent cultivability of periodontal pathogens will be measured by number of pathogen specific CFUs in proportion to total cultivability. Differences in microbial load will be investigated with the paired t-test. If the assumption of normality is unmet, the Wilcoxon rank-sum test will be used instead.

Full Information

First Posted
December 9, 2016
Last Updated
January 9, 2018
Sponsor
Tufts University School of Dental Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT03003689
Brief Title
Effects of Scaling and Root Planing With and Without Er:YAG Laser in Chronic Periodontitis Patients
Official Title
Randomized Clinical Trial Assessing the Clinical Outcomes and Recolonization Patterns Following Scaling and Root Planing With and Without Using Er.YAG Laser in Chronic Periodontitis Patients
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Unknown status
Study Start Date
April 20, 2017 (Actual)
Primary Completion Date
March 2018 (Anticipated)
Study Completion Date
March 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tufts University School of Dental Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
Dental bacterial plaque is the most frequent modifiable finding in patients with periodontal (gum) diseases. Many studies have provided evidence that mechanical removal of dental plaque is critical for improving the periodontal health. The standard initial treatment of periodontitis (gum disease) is to remove plaque and calculus form the teeth and root structures using sclaing and root planing (SRP). Typically hand instruments and an ultrasonic scaler are used for SRP While this method removes some of the bacteria that leads to periodontitis, microorganisms are not completely eliminated through SRP. Studies have shown that after 3 months, the bacteria initially present prior to scaling and root planing had recolonized. In order to prevent recurrence of periodontitis, it is recommended that oral bacteria be kept at low levels. When used at the proper wave length, dental lasers have been shown to effectively removes calculus, without damaging surrounding tissue. The Er:YAG laser has been FDA-approved for the use of scaling and root planing in Dentistry. While studies on the Er:YAG laser have shown that it is effective in removing calculus and preserving the tooth root structure, there is no consensus of the level of calculus removal. The Er:YAG laser may also be more effective in removing microbial bacteria than SRP with hand instruments and ultrasonic scaler. The purpose of this study is to evaluate the effectiveness of the Er:YAG laser, as an adjunct to scaling and root planing, in removing microbial bacteria. Participants with chronic periodontitis will be randomized to have one quadrant undergo scaling and root planing using hand instruments and ultrasonic scaler alone, while a second quadrant will receive the same treatment, with the addition of the Er:YAG laser. Outcomes studies will be traditional periodontal clinical parameters at 6 weeks and 3 months after treatment. Microbial cultures will be performed at baseline and 3 months to compare survival and re-population by periodontal microorganisms.
Detailed Description
Primary Aim: The primary aim of this study is to evaluate the efficacy of Er:YAG laser as an adjunct to mechanical scaling and root planing periodontal therapy by comparing probing depth and clinical attachment levels. Secondary aim: The secondary aim of this study is to evaluate the efficacy of Er:YAG laser as an adjunct to mechanical scaling and root planing periodontal therapy by comparing gingival bleeding index and plaque index. Tertiary aim: The tertiary aim of this study is to compare the microbial outcomes of mechanical periodontal therapy alone vs. mechanical therapy combined followed with Er:YAG laser therapy at the same time.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Periodontitis
Keywords
Scaling and Root Planing, Er:YAG

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
56 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Scaling and Root Planing
Arm Type
Active Comparator
Arm Description
Hand instruments + ultrasonic scaler PD, CAL, plaque index and gingival bleeding index will be measured at baseline, 6 weeks and 3 months. Microbial load will be measured at baseline and 3 months.
Arm Title
Scaling and Root Planing + Er:YAG Laser
Arm Type
Experimental
Arm Description
Er:YAG Laser, hand instruments + ultrasonic scaler PD, CAL, plaque index and gingival bleeding index will be measured at baseline, 6 weeks and 3 months. Microbial load will be measured at baseline and 3 months.
Intervention Type
Procedure
Intervention Name(s)
Scaling and Root Planing
Intervention Description
Standard of care scaling and root planing using hand instruments and ultrasonic scaler
Intervention Type
Device
Intervention Name(s)
Er:YAG Laser
Intervention Description
Er:YAG laser as an adjunct therapy to standard of care scaling and root planing using hand instruments and ultrasonic
Primary Outcome Measure Information:
Title
Change in Probing Depth
Description
Differences in pocket depth reduction between laser treatment and control groups will be analyzed with a linear mixed effects model. Four sites (mesiolingual, mesiobuccal, distolingual, and distobuccal) per tooth will be averaged and used in the linear mixed effects model. Normality of the data will be assessed graphically and with the Shapiro-Wilk test.
Time Frame
Up to 3 months
Title
Change in Clinical Attachment Levels
Description
Differences in attachment gain between laser treatment and control groups will be analyzed with a linear mixed effects model. Four sites (mesiolingual, mesiobuccal, distolingual, and distobuccal) per tooth will be averaged and used in the linear mixed effects model. Normality of the data will be assessed graphically and with the Shapiro-Wilk test.
Time Frame
Up to 3 months
Secondary Outcome Measure Information:
Title
Change in Gingival Bleeding Index
Description
The gingival bleeding index (the number of bleeding sites divided by the total number of sites) will be calculated. Statistical significance between the two groups' gingival bleeding index will be determined with generalized estimating equations.
Time Frame
Up to 3 months
Title
Change in Plaque Index
Description
The plaque index (the number of surfaces with plaque divided by the total number of surfaces) will be calculated. Statistical significance between the two groups' plaque index will be determined with generalized estimating equations.
Time Frame
Up to 3 months
Title
Change in microbial load, measured in Colony Forming Units (CFUs)
Description
Microbial load will be measured by the total number of cultivable bacteria measured by total viable colony forming units (CFUs) on non-selective and selective media. Percent cultivability of periodontal pathogens will be measured by number of pathogen specific CFUs in proportion to total cultivability. Differences in microbial load will be investigated with the paired t-test. If the assumption of normality is unmet, the Wilcoxon rank-sum test will be used instead.
Time Frame
baseline, 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients enrolled in the Post-Graduate Periodontology Clinic at Tufts University School of Dental Medicine (TUSDM) Recent (within the past 30 days) diagnosis of moderate to severe chronic periodontitis in at least two quadrants according to the Armitage Classification Have had full mouth and vertical bite-wing series of diagnostic radiographs exposed at TUSDM within 6 months preceding entry of the study as a standard of care Have a treatment plan made by the original provider and certified by the PI based on the working diagnosis, presenting etiology, and the predicted therapeutic outcomes of the case (prognosis). Each of the two selected quadrants should have at least 5 teeth including the canine, first premolar and second premolar in contact with at least one tooth that has ≥ 5 mms and ≤ 9 mms probing depths with bleeding on probing. Exclusion Criteria: Participants must not have had mechanical debridement or any other professional periodontal therapy within 6 months preceding entering the study Participants with significant chronic oral soft tissue pathology (lichen planus, Benign Mucous Membrane Pemphigoid, Steven Johnson's Syndrome, Sjogren's Syndrome, etc.) which might affect host response to the presence of bacteria. Participants with fixed appliances or partial dentures, to standardize the effect of the treatment since they are plaque retentive. Participants who smoke tobacco Participants who require prophylactic antibiotics prior to dental treatment Participants who have taken systemic antibiotic medications within the previous 6 months Participants with uncontrolled systemic conditions or disease such as diabetes and immunological disorders Participants with known drug allergies or known adverse effects following the use of oral hygiene products. Participants who are pregnant or lactating Teeth with grade III mobility or teeth with hopeless prognosis indicated for extraction
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amanda Program Manager
Phone
614-636-2147
Email
dentalresearchadministration@tufts.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles Hawley, DDS, MS, PhD
Organizational Affiliation
TUSDM
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tufts University School of Dental Medicine
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charles Hawley, DDS, MS, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Effects of Scaling and Root Planing With and Without Er:YAG Laser in Chronic Periodontitis Patients

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