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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LANAP Quadrant | Active Comparator | Treated with LANAP |
|
| Modified Widman Flap | No Intervention | Quadrant treated with Modified Widman Flap surgery | |
| Scaling and Root Planing | No Intervention | Quadrant treated with scaling and root planing alone | |
| Coronal Debridement | No Intervention | Quadrant treated with coronal debridement |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LANAP | Device | Laser Assisted New Attachment Procedure (LANAP protocol) using the FR Pulsed Nd:YAG laser |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 6, 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Probing Depth (PD) | Positive numbers indicate average decrease in probing depth (improvement). | Baseline, 6, 12 months |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Raymund A Yukna, DMD, MS | University of Colorado Scholl of Dentistry | Study Director |
| Henry Greenwell, DMD. MSD | University of Louisville, School of Dentistry | Principal Investigator |
| Mark Reynolds, DDS, PhD | University of Maryland, School of Dentistry | Principal Investigator |
| James Finley, DMD | Finley Periodontics | Principal Investigator |
| Thomas McCawley, DDS | McCawly & DeTure | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado | Denver | Colorado | 80045 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Data are for number of quadrants
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | 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. | 5-6 mm baseline PD partition had a different sample size than the 7+mm partition. | Posted | Mean | Standard Deviation | mm | Baseline, 6, 12 months | pockets | Participants |
|
1 year
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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 | LANAP Quadrant | Treated with LANAP LANAP: Laser Assisted New Attachment Procedure (LANAP protocol) using the FR Pulsed Nd:YAG laser |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. David Harris | Millenium Dental Technologies, Inc | 510-502-3345 | dharris@LANAP.com |
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| ID | Term |
|---|---|
| D055113 | Chronic Periodontitis |
| ID | Term |
|---|---|
| D010518 | Periodontitis |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| Baseline, 6, 12 months |
| 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. | Baseline, 6, 12 months |
| 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. | 1-7 days |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Average Probing Depth (PD) | Mean | Standard Deviation | mm |
|
| Average Clinical Attachment Level (CAL) | Mean | Standard Deviation | mm |
|
| Bleeding on Probing (BOP) | Percent of pockets within a quadrant that bled on probing by time and treatment | Mean | Standard Deviation | percentage of pockets |
|
| Gingival Index (GI) | Modified Gingival Index of Lobene et al (1986). Inflammation rated 0 (none) to 4 (severe). | Mean | Standard Deviation | units on a scale |
|
Treated with LANAP
LANAP: Laser Assisted New Attachment Procedure (LANAP protocol) using the FR Pulsed Nd:YAG laser
| OG002 | Modified Widman Flap (5-6mm Pockets) | Quadrant treated with Modified Widman Flap surgery |
| OG003 | Modified Widman Flap (≥7mm Pockets) | Quadrant treated with Modified Widman Flap surgery |
| OG004 | Scaling and Root Planing (5-6mm Pockets) | Quadrant treated with scaling and root planing alone |
| OG005 | Scaling and Root Planing (≥7mm Pockets) | Quadrant treated with scaling and root planing alone |
| OG006 | Coronal Debridement (5-6mm Pockets) | Quadrant treated with coronal debridement |
| OG007 | Coronal Debridement (≥7mm Pockets) | Quadrant treated with coronal debridement |
|
|
| Secondary | Change in Probing Depth (PD) | Positive numbers indicate average decrease in probing depth (improvement). | Posted | Mean | Standard Deviation | mm | Baseline, 6, 12 months | pockets | Participants |
|
|
|
| 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. | Posted | Mean | Standard Deviation | percentage of pockets that bled | Baseline, 6, 12 months | quadrants | Participants |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale from 0-4 | Baseline, 6, 12 months | locations | Participants |
|
|
|
| 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. | Subjects with missing data (e.g., missing diary entries) are not included in the analysis. | Posted | Median | Full Range | sum of units on a scale | 1-7 days | quadrants | Participants |
|
|
|
| 0 |
| 59 |
| 0 |
| 59 |
| EG001 | Modified Widman Flap | Quadrant treated with Modified Widman Flap surgery | 0 | 59 | 0 | 59 |
| EG002 | Scaling and Root Planing | Quadrant treated with scaling and root planing alone | 0 | 59 | 0 | 59 |
| EG003 | Coronal Debridement | Quadrant treated with coronal debridement | 0 | 59 | 0 | 59 |
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| D002908 |
| Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| 5-6mm @ 12 mo |
|
| >=7mm @ 6 mo |
|
| >=7mm @ 12 mo |
|
| quadrants |
|
| change @ 12mo |
|
| locations |
|
| 12 months |
|
| quadrants |
|