Trial Outcomes & Findings for Treatment of Periodontitis With Er:YAG Laser (NCT NCT03628872)
NCT ID: NCT03628872
Last Updated: 2024-12-09
Results Overview
Calculated based on distance from CEJ to gingival margin and the pocket depth (site specific measurement)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
29 participants
Primary outcome timeframe
3 months after treatment
Results posted on
2024-12-09
Participant Flow
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).
Unit of analysis: mouth quadrant
Participant milestones
| Measure |
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.
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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.
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|---|---|---|
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Overall Study
STARTED
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26 52
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26 52
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Overall Study
COMPLETED
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26 52
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26 52
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Overall Study
NOT COMPLETED
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0 0
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0 0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Treatment of Periodontitis With Er:YAG Laser
Baseline characteristics by cohort
| Measure |
All Participants
n=29 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.
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|---|---|
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Race/Ethnicity, Customized
White
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4 Participants
n=5 Participants
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Race/Ethnicity, Customized
African American
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5 Participants
n=5 Participants
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Race/Ethnicity, Customized
Hispanic
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15 Participants
n=5 Participants
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Race/Ethnicity, Customized
Asian
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2 Participants
n=5 Participants
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Race/Ethnicity, Customized
Not reported
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3 Participants
n=5 Participants
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Region of Enrollment
United States
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29 participants
n=5 Participants
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Age, Continuous
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52.21 years
n=5 Participants
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Sex: Female, Male
Female
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14 Participants
n=5 Participants
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Sex: Female, Male
Male
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15 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: 3 months after treatmentPopulation: 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.
Calculated based on distance from CEJ to gingival margin and the pocket depth (site specific measurement)
Outcome measures
| Measure |
Conventional Scaling and Root Planing
n=52 Mouth quadrant
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).
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
n=52 Mouth quadrant
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.
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|---|---|---|
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Change in Clinical Attachment Level (CAL)
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3.5 mm
Standard Error 0.7
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3.4 mm
Standard Error 0.4
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PRIMARY outcome
Timeframe: 3 months after treatmentPopulation: 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.
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.
Outcome measures
| Measure |
Conventional Scaling and Root Planing
n=52 Mouth quadrant
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).
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
n=52 Mouth quadrant
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.
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|---|---|---|
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Change in Pocket Depth (PD)
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3.12 mm
Standard Deviation 0.56
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3.13 mm
Standard Deviation 0.49
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SECONDARY outcome
Timeframe: 3 months after treatmentPopulation: 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.
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).
Outcome measures
| Measure |
Conventional Scaling and Root Planing
n=52 Mouth quadrant
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).
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
n=52 Mouth quadrant
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.
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|---|---|---|
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Plaque Index (PI)
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61.16 percent
Standard Deviation 33.66
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65.22 percent
Standard Deviation 32.21
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SECONDARY outcome
Timeframe: 3 months after treatmentPopulation: 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.
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).
Outcome measures
| Measure |
Conventional Scaling and Root Planing
n=52 Mouth quadrant
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).
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
n=52 Mouth quadrant
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.
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|---|---|---|
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Bleeding on Probing (BoP)
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29.21 percent
Standard Deviation 23.92
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31.34 percent
Standard Deviation 22.22
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SECONDARY outcome
Timeframe: Time between the start of treatment to treatment completion, up to 180 minutesPopulation: 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.
Comparison of duration of treatment between the 2 modalities
Outcome measures
| Measure |
Conventional Scaling and Root Planing
n=52 Mouth quadrant
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).
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
n=52 Mouth quadrant
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.
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|---|---|---|
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Average Duration of Treatment
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92.04 minutes
Interval 60.0 to 138.0
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54.15 minutes
Interval 40.0 to 82.0
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SECONDARY outcome
Timeframe: 3 months after treatmentParticipants were given 2 multiple choice questions to assess their modality of preference and the reasoning behind it.
Outcome measures
| Measure |
Conventional Scaling and Root Planing
n=26 Participants
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).
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
n=26 Participants
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.
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|---|---|---|
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Number of Participants Who Preferred Modality
Participants who preferred Conventional Scaling and Root Planning modality
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0 participants
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0 participants
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Number of Participants Who Preferred Modality
Participants who had no preference between the 2 modalities
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5 participants
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5 participants
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Number of Participants Who Preferred Modality
Participants who preferred Er:YAG Laser modality
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21 participants
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21 participants
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SECONDARY outcome
Timeframe: Baseline and 3 monthsPopulation: 9 patients experienced no differences in sensitivity according to the modality.
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.
Outcome measures
| Measure |
Conventional Scaling and Root Planing
n=26 Participants
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).
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
n=26 Participants
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.
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|---|---|---|
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Number of Patients Who Experienced a Better Improvement in Sensitivity
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0 participants
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17 participants
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Adverse Events
Scaling and Root Planing With Hand Instruments
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Scaling and Root Planing With Er:YAG Laser
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
All Participants
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Philip Y Kang
Columbia University College of Dental Medicine
Phone: 212-342-5244
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place