Chronic Periodontitis
Conditions
Keywords
LANAP, Laser dentistry
Brief summary
The purpose of this study is to compare the Laser Assisted New Attachment Procedure (LANAP protocol) using the Free-running (FR) Pulsed Neodimium: Yttrium aluminium garnet (Nd:YAG) laser to Scaling and Root Planing (SRP) alone, Modified Widman Flap (MFF) surgery, and Coronal Debridement (CD) alone with respect to periodontal clinical attachment level gain.
Detailed description
This multi-center study of the Laser Assisted New Attachment Procedure (LANAP protocol) using the FR Pulsed Nd:YAG laser compared to Scaling and Root Planing alone, Modified Widman Flap (MWF) surgery, and Coronal Debridement (CD) alone will utilize a single-blind, four-quadrant split-mouth design with MWF as the positive control, CD as a weak positive control and SRP as the standard treatment control. The study will be conducted at three (3) to five (5) investigational centers. Subjects will receive the Laser Assisted New Attachment Procedure (LANAP protocol) using the pulsed FR Nd:YAG laser, Scaling and Root Planing alone, Modified Widman Flap surgery, and Coronal Debridement alone each in one quadrant of their mouth at Baseline. Treatment modalities are randomly assigned to quadrants at the time of treatment. Efficacy evaluations, including clinical attachment level (CAL), probing depth (PD), and bleeding on probing (BOP) will be performed at Baseline, month 6, and month 12 using a Florida Electronic Probe. Radiographs will be taken at Screening/Baseline and at month 6 and month 12.
Interventions
DEVICELANAP
Laser Assisted New Attachment Procedure (LANAP protocol) using the FR Pulsed Nd:YAG laser
Sponsors
Institute for Advanced Laser Dentistry
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
25 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Subjects will have chronic adult periodontitis as characterized by all four quadrants of the mouth. 2. Subjects will be 25-75 years of age. 3. Subjects will be able to follow verbal and/or written instructions, perform Oral Hygiene according to the protocol, and return to the center for specified study visits. 4. Subjects must have had no subgingival scaling instrumentation including scaling and root planing, regular periodontal maintenance procedures or any subgingival cleaning \< 12 (twelve) months prior to Baseline examination. 5. Subjects must have had no history of periodontal surgical procedures of any type prior to Baseline examination. 6. Subjects must be non-smokers of any type or former smokers (\>6 (six) months stopped), and not using or taking any nicotine product. 7. Subjects will have clinical and/or radiographic evidence of subgingival calculus in each quadrant. 8. Subjects have no more than one missing tooth per quadrant, excluding 3rd molars. 9. Subjects will be able to sign the informed consent form.
Exclusion criteria
1. Subject receiving subgingival scaling instrumentation including scaling and root planing, regular periodontal maintenance procedures or any subgingival cleaning less than twelve (12) months prior to Baseline examination. 2. Subjects receiving periodontal surgery of any type prior to Baseline examination. 3. Subjects with dental implants. 4. Subjects with a compromised heart condition, history of rheumatic fever, or joint replacement requiring prophylaxis. 5. Subjects having taken systemic cancer therapy and/or radiation therapy at any time 6. Subjects with clinically significant acute or concurrent illness 7. Subjects with clinically significant chronic illness. 8. Subjects with a disease of the connective tissue. 9. Subjects taking medications which are likely to cause gingival hyperplasia, within ONE MONTH prior to Baseline examination 10. Subjects taking antimicrobials within ONE MONTH prior to Baseline examination 11. Subjects taking non-steroidal anti-inflammatory drugs at a therapeutic dose within the TWO WEEKS prior to Baseline examination. 12. Subjects taking steroids of any kind within ONE MONTH prior to baseline examination. 13. Subjects taking continuous low doses of tetracycline within THREE MONTHS prior to Baseline examination 14. Subjects taking an investigational drug within TWO MONTHS prior to Baseline examination 15. Subjects taking or having taken bisphosphonates of any kind for any reason. 16. Female, nonsterile subjects who are pregnant or lactating. 17. Subjects who, in the investigator's opinion, would not comply with the study procedures. 18. Smokers of any type or former smokers and subjects that take or use any nicotine product. 19. Excessive alcohol intake. 20. No current restorative or endodontic treatment needs
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gain in Clinical Attachment Level of Periodontal Tissues | Baseline, 6, 12 months | Periodontitis causes loss of attachment of the tooth root to the surrounding bone. Change in Clinical Attachment Level (CAL) estimates the number of mm's of reattachment gained as a result of the treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Probing Depth (PD) | Baseline, 6, 12 months | Positive numbers indicate average decrease in probing depth (improvement). |
| Change in Bleeding on Probing (BOP) | Baseline, 6, 12 months | Percent of pockets within a quadrant that changed from baseline to 6 or 12 months. Negative numbers are a decrease in bleeding on probing which represents clinical improvement. Each quadrant within the patient represents one of four treatments, the unit of analysis. Pockets are replications within treatments and vary in number among quadrants. |
| Change in Gingival Index | Baseline, 6, 12 months | The gingival index is a 0-4 unit scale that the examiner uses to estimate the amount of edema and erythema at 2 locations (lingual and buccal) for every tooth in the quadrant. Zero (0) represents no redness and swelling and four (4) represents severe redness and swelling. Negative numbers are a decrease in in examiner estimate of erythema and edema and represent an improvement in clinical outcome. |
| Discomfort | 1-7 days | Subjects recorded in a diary discomfort on a 10 point visual analog scale daily for the week following treatment. Subjects provided an estimate for each of the four treated quadrants. Zero (0) represents no pain or discomfort and ten (10) represents severe pain and/or discomfort. For each subject discomfort scores on each day from Day 1 to Day 7 were summed. Medians and ranges for each treatment are recorded. The total score could range from 0 to 70. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Participants Subjects will receive the Laser Assisted New Attachment Procedure (LANAP protocol) using the pulsed FR Nd:YAG laser, Scaling and Root Planing alone, Modified Widman Flap surgery, and Coronal Debridement alone each in one randomized quadrant of their mouth at Baseline. | 57 |
| Total | 57 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Protocol Violation | 2 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 6 Participants |
| Age, Categorical Between 18 and 65 years | 51 Participants |
| Average Clinical Attachment Level (CAL) PD = 5-6mm (Coronal Debridement) | 5.468 mm STANDARD_DEVIATION 1.486 |
| Average Clinical Attachment Level (CAL) PD = 5-6mm (LANAP Quadrant) | 5.431 mm STANDARD_DEVIATION 1.301 |
| Average Clinical Attachment Level (CAL) PD = 5-6mm ( Modified Widman Flap) | 5.440 mm STANDARD_DEVIATION 1.349 |
| Average Clinical Attachment Level (CAL) PD = 5-6mm (Scaling and Root Planing) | 5.364 mm STANDARD_DEVIATION 1.244 |
| Average Clinical Attachment Level (CAL) PD >= 7mm (Coronal Debridement) | 7.681 mm STANDARD_DEVIATION 1.659 |
| Average Clinical Attachment Level (CAL) PD >= 7mm (LANAP Quadrant) | 7.453 mm STANDARD_DEVIATION 1.594 |
| Average Clinical Attachment Level (CAL) PD >= 7mm (Modified Widman Flap) | 7.737 mm STANDARD_DEVIATION 1.586 |
| Average Clinical Attachment Level (CAL) PD >= 7mm (Scaling and Root Planing) | 7.528 mm STANDARD_DEVIATION 1.751 |
| Average Probing Depth (PD) PD = 5-6mm (Coronal Debridement) | 5.382 mm STANDARD_DEVIATION 0.554 |
| Average Probing Depth (PD) PD = 5-6mm (LANAP Quadrant) | 5.364 mm STANDARD_DEVIATION 0.553 |
| Average Probing Depth (PD) PD = 5-6mm ( Modified Widman Flap) | 5.358 mm STANDARD_DEVIATION 0.569 |
| Average Probing Depth (PD) PD = 5-6mm (Scaling and Root Planing) | 5.358 mm STANDARD_DEVIATION 0.57 |
| Average Probing Depth (PD) PD >= 7mm (Coronal Debridement) | 7.672 mm STANDARD_DEVIATION 1.069 |
| Average Probing Depth (PD) PD >= 7mm (LANAP Quadrant) | 7.606 mm STANDARD_DEVIATION 0.867 |
| Average Probing Depth (PD) PD >= 7mm (Modified Widman Flap) | 7.562 mm STANDARD_DEVIATION 0.901 |
| Average Probing Depth (PD) PD >= 7mm (Scaling and Root Planing) | 7.657 mm STANDARD_DEVIATION 0.967 |
| Bleeding on Probing (BOP) Coronal Debridement | 47.5 percentage of pockets STANDARD_DEVIATION 31.2 |
| Bleeding on Probing (BOP) LANAP Quadrant | 49.4 percentage of pockets STANDARD_DEVIATION 31.4 |
| Bleeding on Probing (BOP) Modified Widman Flap | 46.5 percentage of pockets STANDARD_DEVIATION 31.2 |
| Bleeding on Probing (BOP) Scaling and Root Planing | 48.2 percentage of pockets STANDARD_DEVIATION 30.6 |
| Gingival Index (GI) Coronal Debridement | 2.43 units on a scale STANDARD_DEVIATION 0.95 |
| Gingival Index (GI) LANAP Quadrant | 2.48 units on a scale STANDARD_DEVIATION 0.95 |
| Gingival Index (GI) Modified Widman Flap | 2.42 units on a scale STANDARD_DEVIATION 0.95 |
| Gingival Index (GI) Scaling and Root Planing | 2.44 units on a scale STANDARD_DEVIATION 0.96 |
| Sex: Female, Male Female | 27 Participants |
| Sex: Female, Male Male | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 59 | 0 / 59 | 0 / 59 | 0 / 59 |
| serious Total, serious adverse events | 0 / 59 | 0 / 59 | 0 / 59 | 0 / 59 |
Outcome results
Primary
Gain in Clinical Attachment Level of Periodontal Tissues
Periodontitis causes loss of attachment of the tooth root to the surrounding bone. Change in Clinical Attachment Level (CAL) estimates the number of mm's of reattachment gained as a result of the treatment.
Time frame: Baseline, 6, 12 months
Population: 5-6 mm baseline PD partition had a different sample size than the 7+mm partition.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LANAP Quadrant (5-6mm Pockets) | Gain in Clinical Attachment Level of Periodontal Tissues | Change in CAL @ 12 mo | 1.498 mm | Standard Deviation 1.638 |
| LANAP Quadrant (5-6mm Pockets) | Gain in Clinical Attachment Level of Periodontal Tissues | Change in CAL @ 6 mo | 1.361 mm | Standard Deviation 1.736 |
| LANAP Quadrant (≥7mm Pockets) | Gain in Clinical Attachment Level of Periodontal Tissues | Change in CAL @ 6 mo | 2.387 mm | Standard Deviation 2.038 |
| LANAP Quadrant (≥7mm Pockets) | Gain in Clinical Attachment Level of Periodontal Tissues | Change in CAL @ 12 mo | 2.458 mm | Standard Deviation 2.005 |
| Modified Widman Flap (5-6mm Pockets) | Gain in Clinical Attachment Level of Periodontal Tissues | Change in CAL @ 6 mo | 1.180 mm | Standard Deviation 1.587 |
| Modified Widman Flap (5-6mm Pockets) | Gain in Clinical Attachment Level of Periodontal Tissues | Change in CAL @ 12 mo | 1.229 mm | Standard Deviation 1.588 |
| Modified Widman Flap (≥7mm Pockets) | Gain in Clinical Attachment Level of Periodontal Tissues | Change in CAL @ 12 mo | 2.120 mm | Standard Deviation 1.84 |
| Modified Widman Flap (≥7mm Pockets) | Gain in Clinical Attachment Level of Periodontal Tissues | Change in CAL @ 6 mo | 2.329 mm | Standard Deviation 1.909 |
| Scaling and Root Planing (5-6mm Pockets) | Gain in Clinical Attachment Level of Periodontal Tissues | Change in CAL @ 6 mo | 1.347 mm | Standard Deviation 1.833 |
| Scaling and Root Planing (5-6mm Pockets) | Gain in Clinical Attachment Level of Periodontal Tissues | Change in CAL @ 12 mo | 1.425 mm | Standard Deviation 1.81 |
| Scaling and Root Planing (≥7mm Pockets) | Gain in Clinical Attachment Level of Periodontal Tissues | Change in CAL @ 12 mo | 2.330 mm | Standard Deviation 2.137 |
| Scaling and Root Planing (≥7mm Pockets) | Gain in Clinical Attachment Level of Periodontal Tissues | Change in CAL @ 6 mo | 2.061 mm | Standard Deviation 2.243 |
| Coronal Debridement (5-6mm Pockets) | Gain in Clinical Attachment Level of Periodontal Tissues | Change in CAL @ 6 mo | 0.796 mm | Standard Deviation 1.723 |
| Coronal Debridement (5-6mm Pockets) | Gain in Clinical Attachment Level of Periodontal Tissues | Change in CAL @ 12 mo | 1.033 mm | Standard Deviation 1.857 |
| Coronal Debridement (≥7mm Pockets) | Gain in Clinical Attachment Level of Periodontal Tissues | Change in CAL @ 12 mo | 1.762 mm | Standard Deviation 2.082 |
| Coronal Debridement (≥7mm Pockets) | Gain in Clinical Attachment Level of Periodontal Tissues | Change in CAL @ 6 mo | 1.573 mm | Standard Deviation 1.945 |
Secondary
Change in Bleeding on Probing (BOP)
Percent of pockets within a quadrant that changed from baseline to 6 or 12 months. Negative numbers are a decrease in bleeding on probing which represents clinical improvement. Each quadrant within the patient represents one of four treatments, the unit of analysis. Pockets are replications within treatments and vary in number among quadrants.
Time frame: Baseline, 6, 12 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LANAP Quadrant (5-6mm Pockets) | Change in Bleeding on Probing (BOP) | change @ 6 mo | -24.9 percentage of pockets that bled | Standard Deviation 32.7 |
| LANAP Quadrant (5-6mm Pockets) | Change in Bleeding on Probing (BOP) | change @ 12mo | -23.0 percentage of pockets that bled | Standard Deviation 29.7 |
| LANAP Quadrant (≥7mm Pockets) | Change in Bleeding on Probing (BOP) | change @ 12mo | -20.4 percentage of pockets that bled | Standard Deviation 28.2 |
| LANAP Quadrant (≥7mm Pockets) | Change in Bleeding on Probing (BOP) | change @ 6 mo | -22.9 percentage of pockets that bled | Standard Deviation 30.7 |
| Modified Widman Flap (5-6mm Pockets) | Change in Bleeding on Probing (BOP) | change @ 6 mo | -23.7 percentage of pockets that bled | Standard Deviation 28 |
| Modified Widman Flap (5-6mm Pockets) | Change in Bleeding on Probing (BOP) | change @ 12mo | -20.1 percentage of pockets that bled | Standard Deviation 27.7 |
| Modified Widman Flap (≥7mm Pockets) | Change in Bleeding on Probing (BOP) | change @ 6 mo | -18.0 percentage of pockets that bled | Standard Deviation 31.2 |
| Modified Widman Flap (≥7mm Pockets) | Change in Bleeding on Probing (BOP) | change @ 12mo | -15.7 percentage of pockets that bled | Standard Deviation 28.4 |
Secondary
Change in Gingival Index
The gingival index is a 0-4 unit scale that the examiner uses to estimate the amount of edema and erythema at 2 locations (lingual and buccal) for every tooth in the quadrant. Zero (0) represents no redness and swelling and four (4) represents severe redness and swelling. Negative numbers are a decrease in in examiner estimate of erythema and edema and represent an improvement in clinical outcome.
Time frame: Baseline, 6, 12 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LANAP Quadrant (5-6mm Pockets) | Change in Gingival Index | 6 months | -1.28 units on a scale from 0-4 | Standard Deviation 1.28 |
| LANAP Quadrant (5-6mm Pockets) | Change in Gingival Index | 12 months | -1.29 units on a scale from 0-4 | Standard Deviation 1.19 |
| LANAP Quadrant (≥7mm Pockets) | Change in Gingival Index | 12 months | -1.27 units on a scale from 0-4 | Standard Deviation 1.22 |
| LANAP Quadrant (≥7mm Pockets) | Change in Gingival Index | 6 months | -1.30 units on a scale from 0-4 | Standard Deviation 1.31 |
| Modified Widman Flap (5-6mm Pockets) | Change in Gingival Index | 6 months | -1.28 units on a scale from 0-4 | Standard Deviation 1.27 |
| Modified Widman Flap (5-6mm Pockets) | Change in Gingival Index | 12 months | -1.26 units on a scale from 0-4 | Standard Deviation 1.2 |
| Modified Widman Flap (≥7mm Pockets) | Change in Gingival Index | 6 months | -1.14 units on a scale from 0-4 | Standard Deviation 1.28 |
| Modified Widman Flap (≥7mm Pockets) | Change in Gingival Index | 12 months | -1.14 units on a scale from 0-4 | Standard Deviation 1.22 |
Secondary
Change in Probing Depth (PD)
Positive numbers indicate average decrease in probing depth (improvement).
Time frame: Baseline, 6, 12 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LANAP Quadrant (5-6mm Pockets) | Change in Probing Depth (PD) | 5-6mm @ 6 mo | 1.674 mm | Standard Deviation 1.402 |
| LANAP Quadrant (5-6mm Pockets) | Change in Probing Depth (PD) | 5-6mm @ 12 mo | 1.888 mm | Standard Deviation 1.446 |
| LANAP Quadrant (5-6mm Pockets) | Change in Probing Depth (PD) | >=7mm @ 6 mo | 2.716 mm | Standard Deviation 1.832 |
| LANAP Quadrant (5-6mm Pockets) | Change in Probing Depth (PD) | >=7mm @ 12 mo | 3.097 mm | Standard Deviation 1.766 |
| LANAP Quadrant (≥7mm Pockets) | Change in Probing Depth (PD) | 5-6mm @ 12 mo | 1.831 mm | Standard Deviation 1.305 |
| LANAP Quadrant (≥7mm Pockets) | Change in Probing Depth (PD) | >=7mm @ 6 mo | 3.117 mm | Standard Deviation 1.585 |
| LANAP Quadrant (≥7mm Pockets) | Change in Probing Depth (PD) | >=7mm @ 12 mo | 3.004 mm | Standard Deviation 1.581 |
| LANAP Quadrant (≥7mm Pockets) | Change in Probing Depth (PD) | 5-6mm @ 6 mo | 1.834 mm | Standard Deviation 1.263 |
| Modified Widman Flap (5-6mm Pockets) | Change in Probing Depth (PD) | >=7mm @ 6 mo | 2.525 mm | Standard Deviation 1.897 |
| Modified Widman Flap (5-6mm Pockets) | Change in Probing Depth (PD) | 5-6mm @ 12 mo | 1.702 mm | Standard Deviation 1.556 |
| Modified Widman Flap (5-6mm Pockets) | Change in Probing Depth (PD) | >=7mm @ 12 mo | 2.846 mm | Standard Deviation 2.001 |
| Modified Widman Flap (5-6mm Pockets) | Change in Probing Depth (PD) | 5-6mm @ 6 mo | 1.550 mm | Standard Deviation 1.486 |
| Modified Widman Flap (≥7mm Pockets) | Change in Probing Depth (PD) | >=7mm @ 12 mo | 2.108 mm | Standard Deviation 1.959 |
| Modified Widman Flap (≥7mm Pockets) | Change in Probing Depth (PD) | 5-6mm @ 12 mo | 1.223 mm | Standard Deviation 1.749 |
| Modified Widman Flap (≥7mm Pockets) | Change in Probing Depth (PD) | 5-6mm @ 6 mo | 1.084 mm | Standard Deviation 1.544 |
| Modified Widman Flap (≥7mm Pockets) | Change in Probing Depth (PD) | >=7mm @ 6 mo | 1.976 mm | Standard Deviation 1.773 |
Secondary
Discomfort
Subjects recorded in a diary discomfort on a 10 point visual analog scale daily for the week following treatment. Subjects provided an estimate for each of the four treated quadrants. Zero (0) represents no pain or discomfort and ten (10) represents severe pain and/or discomfort. For each subject discomfort scores on each day from Day 1 to Day 7 were summed. Medians and ranges for each treatment are recorded. The total score could range from 0 to 70.
Time frame: 1-7 days
Population: Subjects with missing data (e.g., missing diary entries) are not included in the analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| LANAP Quadrant (5-6mm Pockets) | Discomfort | 10 sum of units on a scale |
| LANAP Quadrant (≥7mm Pockets) | Discomfort | 19 sum of units on a scale |
| Modified Widman Flap (5-6mm Pockets) | Discomfort | 4.4 sum of units on a scale |
| Modified Widman Flap (≥7mm Pockets) | Discomfort | 3.5 sum of units on a scale |