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

NCT03003689 | Unknown FDA Device

• 1 other identifier: 12321
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Periodontitis

Keywords

Scaling and Root Planing; Er:YAG

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Up to 3 months

Secondary Outcomes (3)

• Change in Gingival Bleeding Index

  Up to 3 months

• Change in Plaque Index

  Up to 3 months

• Change in microbial load, measured in Colony Forming Units (CFUs)

  baseline, 3 months

Study Arms (2)

Scaling and Root Planing

ACTIVE COMPARATOR

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.

Procedure: Scaling and Root Planing

Scaling and Root Planing + Er:YAG Laser

EXPERIMENTAL

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.

Procedure: Scaling and Root Planing; Device: Er:YAG Laser

Interventions

Scaling and Root Planing PROCEDURE

Standard of care scaling and root planing using hand instruments and ultrasonic scaler

Scaling and Root Planing; Scaling and Root Planing + Er:YAG Laser

Er:YAG Laser DEVICE

Er:YAG laser as an adjunct therapy to standard of care scaling and root planing using hand instruments and ultrasonic

Scaling and Root Planing + Er:YAG Laser

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Tufts University School of Dental Medicine: lead

Study Sites (1)

Tufts University School of Dental Medicine

Boston, Massachusetts, 02111, United States

RECRUITING

MeSH Terms

Conditions

Chronic Periodontitis

Interventions

Tooth Exfoliation; Root Planing; Lasers, Solid-State

Condition Hierarchy (Ancestors)

Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena; Dental Scaling; Dental Prophylaxis; Periodontics; Dentistry; Subgingival Curettage; Preventive Dentistry; Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Officials

• Charles Hawley, DDS, MS, PhD

  TUSDM

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amanda Program Manager

CONTACT

614-636-2147; dentalresearchadministration@tufts.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2016
• First Posted: December 28, 2016
• Study Start: April 20, 2017
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: January 11, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)