Treatment of Periodontitis With Er:YAG Laser

Not Applicable

Completed

Conditions: Periodontal Diseases
Generalized Moderate Chronic Periodontitis
Generalized Severe Chronic Periodontitis

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.

Recruitment & 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

Arm && Interventions

Group	Intervention	Description
Scaling and Root Planing with Hand Instruments	Scaling and root planing	Patients will undergo scaling and root planing with hand instruments (half of their mouth, following a split-mouth design)
Er:YAG Laser Scaling	Scaling and root planing	Patients will undergo scaling and root planing with Er:YAG Laser in the untreated half of their mouth.
Scaling and Root Planing with Hand Instruments	Hand instruments	Patients will undergo scaling and root planing with hand instruments (half of their mouth, following a split-mouth design)

Primary Outcome Measures

Name	Time	Method
Change in Clinical Attachment Level (CAL)	3 months after treatment	Calculated based on distance from CEJ to gingival margin and the pocket depth (site specific measurement)
Change in Pocket Depth (PD)	3 months after treatment	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.

Secondary Outcome Measures

Name	Time	Method
Plaque Index (PI)	3 months after treatment	Plaque and calculus accumulation on tooth surfaces (site specific measurement). Plaque Index is calculated by \[number of sites with plaque\] divided by \[number of sites evaluated\], multiplied by 100 (represented as a percent).
Bleeding on Probing (BoP)	3 months after treatment	Bleeding after probing the pocket (site specific measurement). BoP is calculated by: \[number of bleeding sites\] divided by \[number of sites evaluated\], multiplied by 100 (represented as a percent).
Average Duration of Treatment	Time between the start of treatment to treatment completion, up to 180 minutes	Comparison of duration of treatment between the 2 modalities
Number of Participants Who Preferred Modality	3 months after treatment	Participants were given 2 multiple choice questions to assess their modality of preference and the reasoning behind it.
Number of Patients Who Experienced a Better Improvement in Sensitivity	Baseline and 3 months	A numeric scale was completed by participants to assess their degree of sensitivity or pain with a modified 0 - 10 scale (i.e.: 0- no pain/sensitivity; 5- moderate pain or sensitivity, may require medication; 10- unbearable sensitivity or pain that impairs my sleep). Baseline and 3 months reported scores were compared within each patient and between modalities. The numbers reported are participants that experienced a better improvement in sensitivity within the respective modality.

Locations (1): Columbia University College of Dental Medicine
🇺🇸
New York, New York, United States