Treatment of Periodontitis With Er:YAG Laser

NCT ID: NCT03628872

Last Updated: 2024-12-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-02
• Study Completion Date: 2019-06-01

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.

Detailed 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.

Conditions

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

Keywords

Scaling and root planing; Laser scaling

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Scaling and Root Planing with Hand Instruments

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

Group Type: ACTIVE_COMPARATOR

Scaling and root planing

Intervention Type: 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.

Hand instruments

Intervention Type: DEVICE

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

Er:YAG Laser Scaling

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

Group Type: EXPERIMENTAL

Scaling and root planing

Intervention Type: 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.

Er:YAG Laser

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

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.

Intervention Type: DEVICE

Hand instruments

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

Intervention Type: DEVICE

Other Intervention Names

Deep cleaning; Erbium-doped Yttrium Aluminium Garnet Laser; Hand instrumentation

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Philip Y. Kang

Assistant Professor of Dental Medicine (Periodontist) at the Columbia University Medical Center, College of Dental Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Philip Kang, DDS, MS

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

Columbia University College of Dental Medicine

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

AAAR6077

Identifier Type: -

Identifier Source: org_study_id