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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| Er:YAG Laser Scaling | Experimental | Patients will undergo scaling and root planing with Er:YAG Laser in the untreated half of their mouth. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Plaque Index (PI) | 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). | 3 months after treatment |
| Bleeding on Probing (BoP) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Philip Kang, DDS, MS | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University College of Dental Medicine | New York | New York | 10032 | United States |
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The same 26 patients received both interventions. Each patient's right and left sides (mouth quadrants) were randomly assigned to receive one of the two treatment modalities using random sequences generated by a software application: conventional scaling and root planing (C-SRP), or conventional scaling with Er:YAG laser-assisted scaling and root planing (L-SRP).
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| ID | Title | Description |
|---|---|---|
| FG000 | Conventional Scaling and Root Planing | Conventional Scaling and Root Planing with hand instruments were randomly assigned to the left or the right mandible side in a split-mouth randomized design. 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. Hand instruments: 11/12 and 13/14 gracey's, mini 11/12 and 13/14 gracey's, 4R/4L curette and sickle scaler - the standard of care choices for performing scaling and root planing. |
| FG001 | Er:YAG | Conventional Scaling and Root Planing with Er:YAG laser were randomly assigned to the left or the right mandible side in a split-mouth randomized design. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | Patients will undergo a split-mouth design, with one half side of the mouth (one side has 2 quadrants which include the upper and lower mouth) receiving non-surgical treatment with conventional scaling and root planing with hand instruments, and the other half side of their mouths receiving non-surgical treatment with conventional scaling and root planing with Er:YAG laser. 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. Hand instruments: 11/12 and 13/14 gracey's, mini 11/12 and 13/14 gracey's, 4R/4L curette and sickle scaler - the standard of care choices for performing scaling and root planing. 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Clinical Attachment Level (CAL) | Calculated based on distance from CEJ to gingival margin and the pocket depth (site specific measurement) | The same 26 patients participated in both arms, where half side of their mouths (52 quadrants - one side has two quadrants) were treated with conventional scaling and root planing and the other half side of their mouths (52 quadrants on the other side) were treated with Er:YAG laser. | Posted | Mean | Standard Error | mm | 3 months after treatment | Mouth quadrant | Mouth quadrant |
|
3 months after treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Scaling and Root Planing With Hand Instruments | Adverse Events localized to the mouth side treated with hand instruments. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Philip Y Kang | Columbia University College of Dental Medicine | 212-342-5244 | pyk2104@cumc.columbia.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 26, 2018 | Aug 9, 2024 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D014080 | Tooth Exfoliation |
| D016745 | Root Planing |
| D053844 | Lasers, Solid-State |
| ID | Term |
|---|---|
| D009063 | Dental Physiological Phenomena |
| D055688 | Digestive System and Oral Physiological Phenomena |
| D012534 | Dental Scaling |
| D003777 | Dental Prophylaxis |
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Examiner was blinded to treatment allocation during baseline and at the 3 month re-evaluation
|
| 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. |
|
|
| Hand instruments | Device | 11/12 and 13/14 gracey, 4R/4L curette and sickle - standard of care choices for performing scaling and root planing. |
|
|
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 months after treatment |
| Average Duration of Treatment | Comparison of duration of treatment between the 2 modalities | Time between the start of treatment to treatment completion, up to 180 minutes |
| Number of Participants Who Preferred Modality | Participants were given 2 multiple choice questions to assess their modality of preference and the reasoning behind it. | 3 months after treatment |
| Number of Patients Who Experienced a Better Improvement in Sensitivity | 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. | Baseline and 3 months |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Er:YAG | Patients will undergo non-surgical treatment with conventional scaling and root planing with hand instruments or Er:YAG following a split-mouth design (both upper and lower quadrants on each side were treated). 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. |
|
|
| Primary | 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. | The same 26 patients participated in both arms, where half of their mouths (52 quadrants) were treated with conventional scaling and root planing and the other half of their mouths (52 quadrants) were treated with Er:YAG laser. | Posted | Mean | Standard Deviation | mm | 3 months after treatment | Mouth quadrant | Mouth quadrant |
|
|
|
| Secondary | Plaque Index (PI) | 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). | The same 26 patients participated in both arms, where half of their mouths (52 quadrants) were treated with conventional scaling and root planing and the other half of their mouths (52 quadrants) were treated with Er:YAG laser. | Posted | Mean | Standard Deviation | percent | 3 months after treatment | Mouth quadrant | Mouth quadrant |
|
|
|
| Secondary | Bleeding on Probing (BoP) | 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). | The same 26 patients participated in both arms, where half of their mouths (52 quadrants) were treated with conventional scaling and root planing and the other half of their mouths (52 quadrants) were treated with Er:YAG laser. | Posted | Mean | Standard Deviation | percent | 3 months after treatment | Mouth quadrant | Mouth quadrant |
|
|
|
| Secondary | Average Duration of Treatment | Comparison of duration of treatment between the 2 modalities | The same 26 patients participated in both arms, where half of their mouths (52 quadrants) were treated with conventional scaling and root planing and the other half of their mouths (52 quadrants) were treated with Er:YAG laser. | Posted | Mean | Full Range | minutes | Time between the start of treatment to treatment completion, up to 180 minutes | Mouth quadrant | Mouth quadrant |
|
|
|
| Secondary | Number of Participants Who Preferred Modality | Participants were given 2 multiple choice questions to assess their modality of preference and the reasoning behind it. | Posted | Number | participants | 3 months after treatment |
|
|
|
| Secondary | Number of Patients Who Experienced a Better Improvement in Sensitivity | 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. | 9 patients experienced no differences in sensitivity according to the modality. | Posted | Number | participants | Baseline and 3 months |
|
|
|
| 0 |
| 26 |
| 0 |
| 26 |
| 0 |
| 26 |
| EG001 | Scaling and Root Planing With Er:YAG Laser | Adverse Events localized to the mouth side treated with Er:YAG Laser. | 0 | 26 | 0 | 26 | 0 | 26 |
| EG002 | All Participants | All Adverse Events, including those that affected participants as a whole (systemic events). | 0 | 26 | 0 | 26 | 0 | 26 |
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| D010517 | Periodontics |
| D003813 | Dentistry |
| D013357 | Subgingival Curettage |
| D011313 | Preventive Dentistry |
| D007834 | Lasers |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
| D055618 | Radiation Equipment and Supplies |
| Participants who had no preference between the 2 modalities |
|