Clinical trial NCT03628872: Treatment of Periodontitis With Er:YAG Laser
Official title: Treatment of Periodontitis Utilizing Two Different Modalities: Erbium-doped Yttrium Aluminium Garnet (Er:YAG) Laser and Conventional Mechanical Debridement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Generalized Moderate Chronic Periodontitis
Generalized Severe Chronic Periodontitis
Periodontal Diseases
Keywords: Scaling and root planing
Laser scaling
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2018-08-14
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Clinical Attachment Level (CAL)
timeFrame: 3 months after treatment
measure: Change in Pocket Depth (PD)
timeFrame: 3 months after treatment
Secondary outcomes:
measure: Plaque Index (PI)
timeFrame: 3 months after treatment
measure: Bleeding on Probing (BoP)
timeFrame: 3 months after treatment
measure: Average Duration of Treatment
timeFrame: Time between the start of treatment to treatment completion, up to 180 minutes
measure: Number of Participants Who Preferred Modality
timeFrame: 3 months after treatment
measure: Number of Patients Who Experienced a Better Improvement in Sensitivity
timeFrame: Baseline and 3 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University College of Dental Medicine
state: New York
Study officials:
affiliation: Columbia University
name: Philip Kang, DDS, MS
role: PRINCIPAL_INVESTIGATOR
References: