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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
56
Standard of care scaling and root planing using hand instruments and ultrasonic scaler
Er:YAG laser as an adjunct therapy to standard of care scaling and root planing using hand instruments and ultrasonic
Tufts University School of Dental Medicine
Boston, Massachusetts, United States
RECRUITINGChange 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.
Time frame: Up to 3 months
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.
Time frame: Up to 3 months
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.
Time frame: Up to 3 months
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.
Time frame: Up to 3 months
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.
Time frame: baseline, 3 months
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