Generalized Moderate Chronic Periodontitis, Generalized Severe Chronic Periodontitis, Periodontal Diseases
Conditions
Keywords
Scaling and root planing, Laser scaling
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.
Interventions
PROCEDUREScaling 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.
DEVICEEr: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.
DEVICEHand instruments
11/12 and 13/14 gracey, 4R/4L curette and sickle - standard of care choices for performing scaling and root planing.
Sponsors
Columbia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Examiner was blinded to treatment allocation during baseline and at the 3 month re-evaluation
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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). |
| 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. |
| 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. |
| 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). |
Countries
United States
Participant flow
Pre-assignment details
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).
Participants by arm
| Arm | Count |
|---|---|
| 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. | 29 |
| Total | 29 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Continuous | 52.21 years |
| Race/Ethnicity, Customized African American | 5 Participants |
| Race/Ethnicity, Customized Asian | 2 Participants |
| Race/Ethnicity, Customized Hispanic | 15 Participants |
| Race/Ethnicity, Customized Not reported | 3 Participants |
| Race/Ethnicity, Customized White | 4 Participants |
| Region of Enrollment United States | 29 participants |
| Sex: Female, Male Female | 14 Participants |
| Sex: Female, Male Male | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 26 | 0 / 26 | 0 / 26 |
| other Total, other adverse events | 0 / 26 | 0 / 26 | 0 / 26 |
| serious Total, serious adverse events | 0 / 26 | 0 / 26 | 0 / 26 |
Outcome results
Primary
Change in Clinical Attachment Level (CAL)
Calculated based on distance from CEJ to gingival margin and the pocket depth (site specific measurement)
Time frame: 3 months after treatment
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Conventional Scaling and Root Planing | Change in Clinical Attachment Level (CAL) | 3.5 mm | Standard Error 0.7 |
| Er:YAG | Change in Clinical Attachment Level (CAL) | 3.4 mm | Standard Error 0.4 |
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.
Time frame: 3 months after treatment
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Conventional Scaling and Root Planing | Change in Pocket Depth (PD) | 3.12 mm | Standard Deviation 0.56 |
| Er:YAG | Change in Pocket Depth (PD) | 3.13 mm | Standard Deviation 0.49 |
Secondary
Average Duration of Treatment
Comparison of duration of treatment between the 2 modalities
Time frame: Time between the start of treatment to treatment completion, up to 180 minutes
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Conventional Scaling and Root Planing | Average Duration of Treatment | 92.04 minutes |
| Er:YAG | Average Duration of Treatment | 54.15 minutes |
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).
Time frame: 3 months after treatment
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Conventional Scaling and Root Planing | Bleeding on Probing (BoP) | 29.21 percent | Standard Deviation 23.92 |
| Er:YAG | Bleeding on Probing (BoP) | 31.34 percent | Standard Deviation 22.22 |
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.
Time frame: 3 months after treatment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Conventional Scaling and Root Planing | Number of Participants Who Preferred Modality | Participants who preferred Er:YAG Laser modality | 21 participants |
| Conventional Scaling and Root Planing | Number of Participants Who Preferred Modality | Participants who preferred Conventional Scaling and Root Planning modality | 0 participants |
| Conventional Scaling and Root Planing | Number of Participants Who Preferred Modality | Participants who had no preference between the 2 modalities | 5 participants |
| Er:YAG | Number of Participants Who Preferred Modality | Participants who preferred Er:YAG Laser modality | 21 participants |
| Er:YAG | Number of Participants Who Preferred Modality | Participants who preferred Conventional Scaling and Root Planning modality | 0 participants |
| Er:YAG | Number of Participants Who Preferred Modality | Participants who had no preference between the 2 modalities | 5 participants |
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.
Time frame: Baseline and 3 months
Population: 9 patients experienced no differences in sensitivity according to the modality.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Conventional Scaling and Root Planing | Number of Patients Who Experienced a Better Improvement in Sensitivity | 0 participants |
| Er:YAG | Number of Patients Who Experienced a Better Improvement in Sensitivity | 17 participants |
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).
Time frame: 3 months after treatment
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Conventional Scaling and Root Planing | Plaque Index (PI) | 61.16 percent | Standard Deviation 33.66 |
| Er:YAG | Plaque Index (PI) | 65.22 percent | Standard Deviation 32.21 |