NCT03003689

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 56 (estimated)
• Sponsor: Tufts University School of Dental Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Chronic Periodontitis

Interventions

Type	Name	Description
PROCEDURE	Scaling and Root Planing	Standard of care scaling and root planing using hand instruments and ultrasonic scaler
DEVICE	Er:YAG Laser	Er:YAG laser as an adjunct therapy to standard of care scaling and root planing using hand instruments and ultrasonic

Timeline

• Start date: 2017-04-20
• Primary completion: 2018-03-01
• Completion: 2018-03-01
• First posted: 2016-12-28
• Last updated: 2018-01-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study