Treatment of Periodontitis With Er:YAG Laser

NCT03628872 | Completed Results FDA Device

• 1 other identifier: AAAR6077
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Generalized Moderate Chronic Periodontitis; Generalized Severe Chronic Periodontitis; Periodontal Diseases

Keywords

Scaling and root planing; Laser scaling

Outcome Measures

Primary Outcomes (2)

• Change in Clinical Attachment Level (CAL)

  Calculated based on distance from CEJ to gingival margin and the pocket depth (site specific measurement)

  3 months after treatment

• Change in Pocket Depth (PD)

  Measured at 6 sites per tooth in millimeters (mm) (site specific measurement). The mean value of the measurements was obtained for both treatment groups by averaging all teeth for each quadrant.

  3 months after treatment

Secondary Outcomes (5)

• Plaque Index (PI)

  3 months after treatment

• Bleeding on Probing (BoP)

  3 months after treatment

• Average Duration of Treatment

  Time between the start of treatment to treatment completion, up to 180 minutes

• Number of Participants Who Preferred Modality

  3 months after treatment

• Number of Patients Who Experienced a Better Improvement in Sensitivity

  Baseline and 3 months

Study Arms (2)

Scaling and Root Planing with Hand Instruments

ACTIVE COMPARATOR

Patients will undergo scaling and root planing with hand instruments (half of their mouth, following a split-mouth design)

Procedure: Scaling and root planing; Device: Hand instruments

Er:YAG Laser Scaling

EXPERIMENTAL

Patients will undergo scaling and root planing with Er:YAG Laser in the untreated half of their mouth.

Procedure: Scaling and root planing; Device: Er:YAG Laser

Interventions

Scaling and root planing PROCEDURE

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.

Also known as: Deep cleaning

Er:YAG Laser Scaling; Scaling and Root Planing with Hand Instruments

Er:YAG Laser DEVICE

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.

Also known as: Erbium-doped Yttrium Aluminium Garnet Laser

Er:YAG Laser Scaling

Hand instruments DEVICE

11/12 and 13/14 gracey, 4R/4L curette and sickle - standard of care choices for performing scaling and root planing.

Also known as: Hand instrumentation

Scaling and Root Planing with Hand Instruments

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University College of Dental Medicine

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Periodontal Diseases

Interventions

Tooth Exfoliation; Root Planing; Lasers, Solid-State

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

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

Results Point of Contact

• Title: Dr. Philip Y Kang
• Organization: Columbia University College of Dental Medicine

pyk2104@cumc.columbia.edu

212-342-5244

Study Officials

• Philip Kang, DDS, MS

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Examiner was blinded to treatment allocation during baseline and at the 3 month re-evaluation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Dental Medicine (Periodontist) at the Columbia University Medical Center, College of Dental Medicine

Study Record Dates

• First Submitted: August 8, 2018
• First Posted: August 14, 2018
• Study Start: March 2, 2018
• Primary Completion: May 1, 2019
• Study Completion: June 1, 2019
• Last Updated: December 9, 2024
• Results First Posted: December 9, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)