Treatment of Periodontitis With Er:YAG Laser

Periodontal Diseases Clinical Trial

Official title:

Treatment of Periodontitis Utilizing Two Different Modalities: Erbium-doped Yttrium Aluminium Garnet (Er:YAG) Laser and Conventional Mechanical Debridement

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03628872
• Other study ID #: AAAR6077
• Status: Completed
• Phase: N/A
• Start date: March 2, 2018
• Est. completion date: June 1, 2019

Study information

• Verified date: October 2019
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this research project is to gain information on the best and most comfortable way to treat the periodontal disease. The main objective is to compare the efficacy of conventional scaling and root planning compared to laser scaling for the non-surgical treatment of periodontal disease. Both therapies have shown to be effective and are regularly used in the dental clinic.

Description:

The study has been designed as a single blinded split-mouth randomized controlled clinical trial. Patients will be randomized prior to treatment, to which the examiner will be blinded. Clinical parameters will be recorded at baseline and 3 months after treatment has been completed. At the time of recruitment, inclusion/exclusion criteria checklist, informed consent and baseline measurements will be obtained and recorded. Medical history will be updated and radiographs will be reviewed or taken. During the second appointment, conventional scaling and root planing will be performed in the corresponding quadrant; during the third appointment, laser therapy will be conducted, 1 month after, during the forth appointment, a follow up (no measurements) will be scheduled with provider, and 3 months after scaling completion, measurements will be taken and periodontal maintenance performed. Patient will receive home care instructions at every visit and will fill out a visual analogue scale at baseline, 1 month and 3 month visit.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: June 1, 2019
• Est. primary completion date: May 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Signed and dated Informed Consent

• Good general health

• Participants > 18 years of age

• Participants with > 20 teeth with 5 teeth, including at least 1 molar, in each quadrant of the mouth

• Participants with > 30% of the present teeth with Probing depths of > 4mm and Bleeding on Probing

• Non-smoker and former smokers (stopped smoking > 1 year)

• Participants that have not received any periodontal treatment in the past 3 months

Exclusion Criteria:

• Participants with uncontrolled systemic diseases that could affect the treatment outcome such as Diabetes with HbA1c > 7.0 percent, rheumatoid arthritis, immunosuppression, HIV with detectable viral loads

• Participants requiring antibiotic prophylaxis for any cardiovascular conditions or after any transplant and/or replacement procedures

• Pregnant women

• Patients treated with systemic antibiotic therapy of periodontal/mechanical/local delivery therapy within 6 weeks prior to study entry and throughout the study duration

• Patients being chronically (two weeks or more) treated with any NSAIDs, steroids or any medications known to affect soft tissue condition (excluding treatment with Acetylsalicylic acid < 100 mg/day)

• Presence of orthodontic appliances, or any removable appliances that impinges on the tissues being assessed.

• Presence of soft or hard tissue tumors of the oral cavity

• The presence of any medical or psychiatric condition or any other condition that, in the opinion of the Investigator, could affect the successful participation of the patient in the study

Related Conditions & MeSH terms

• Chronic Periodontitis
• Generalized Moderate Chronic Periodontitis
• Generalized Severe Chronic Periodontitis
• Periodontal Diseases
• Periodontitis

Intervention

Procedure:
• Scaling and root planing
A non-surgical procedure that treats periodontal disease, sometimes called a deep cleaning, is considered the "gold standard" (standard of care) of treatment for patients with chronic periodontitis.

Device:
• Er:YAG Laser
This laser is intended to be used for dental surgery. The Er:YAG Laser emits an infrared beam which is readily absorbed by water contained by both hard and soft tissues of the human body. As a result, energy of the laser beam instantly vaporizes the water molecules in soft and hard tissues of the tooth and surrounding tissues causing the tissues to crumble away or resection of the soft tissues of gingival.
• Hand instruments
11/12 and 13/14 gracey, 4R/4L curette and sickle - standard of care choices for performing scaling and root planing.

Locations

Country	Name	City	State
United States	Columbia University College of Dental Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Columbia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Clinical Attachment Level (CAL)	Calculated based on distance from CEJ to gingival margin and the pocket depth (site specific measurement)	Recorded at baseline and 3 months after treatment
Primary	Change in Pocket Depth (PD)	Measured at 6 sites per tooth in millimeters (mm) (site specific measurement)	Recorded at baseline and 3 months after treatment
Secondary	Change in Plaque Index (PI)	Plaque and calculus accumulation on tooth surfaces (site specific measurement)	Recorded at baseline and 3 months after treatment
Secondary	Difference in timing	Timing spent performing the 2 different types of therapy	During the time both therapies are performed
Secondary	Differences in sensitivity	Visual Analogue Scale (VAS) from 0-10 and 4 multiple choice questions to assess patient's sensitivity and their level of satisfaction and preference towards both modalities.	VAS completed at baseline, 1 month follow up and 3 months re-evaluation
Secondary	Change in Bleeding on Probing (BoP)	Bleeding after probing the pocket (site specific measurement)	Recorded at baseline and 3 months after treatment