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Completed

NCT Number: NCT03628872

Treatment of Periodontitis With Er:YAG Laser

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.

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Key information

Conditions

Generalized Moderate Chronic Periodontitis Generalized Severe Chronic Periodontitis Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Columbia University College of Dental Medicine

New York, 10032, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Deep cleaning

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.

Other names: Erbium-doped Yttrium Aluminium Garnet Laser

Hand Instruments

Device

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

Other names: Hand instrumentation

Primary outcomes

  1. Change in Clinical Attachment Level (CAL)

    Time frame: 3 months after treatment

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

  2. Change in Pocket Depth (PD)

    Time frame: 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 outcomes

  1. Plaque Index (PI)

    Time frame: 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).

  2. Bleeding on Probing (BoP)

    Time frame: 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).

  3. Average Duration of Treatment

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

    Comparison of duration of treatment between the 2 modalities

  4. Number of Participants Who Preferred Modality

    Time frame: 3 months after treatment

    Participants were given 2 multiple choice questions to assess their modality of preference and the reasoning behind it.

  5. Number of Patients Who Experienced a Better Improvement in Sensitivity

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 14, 2018
Registry last updated
Dec 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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