Study to Compare Laser Assisted New Attachment Procedure (LANAP) to Traditional Treatments of Chronic Periodontitis
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Purpose
The purpose of this study is to compare the Laser Assisted New Attachment Procedure (LANAP protocol) using the FR Pulsed 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.
| Condition | Intervention |
|---|---|
|
Chronic Periodontitis |
Device: LANAP |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Multi-Center Single Blind Study of the Laser Assisted New Attachment Procedure Compared to Scaling and Root Planing Alone, Modified Widman Flap Surgery, and Coronal Debridement Alone in the Treatment of Chronic Periodontitis |
- Gain in Clinical Attachment Level of periodontal tissues [ Time Frame: 1 year ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 125 |
| Study Start Date: | October 2010 |
| Estimated Study Completion Date: | September 2013 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: LANAP Quadrant
Treated with LANAP
|
Device: LANAP
Laser Assisted New Attachment Procedure (LANAP protocol) using the FR Pulsed Nd:YAG laser
Other Name: Periolase MVP 7
|
|
No Intervention: Modified Widman Flap
Quadrant treated with Modified Widman Flap surgery
|
|
|
No Intervention: Scaling and Root Planing
Quadrant treated with scaling and root planing alone
|
|
|
No Intervention: Coronal Debridement
Quadrant treated with coronal debridement
|
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.
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.
Eligibility| Ages Eligible for Study: | 25 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Subjects will have chronic adult periodontitis as characterized by all four quadrants of the mouth.
- Subjects will be 25-75 years of age.
- 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.
- 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.
- Subjects must have had no history of periodontal surgical procedures of any type prior to Baseline examination.
- Subjects must be non-smokers of any type or former smokers (>6 (six) months stopped), and not using or taking any nicotine product.
- Subjects will have clinical and/or radiographic evidence of subgingival calculus in each quadrant.
- Subjects have no more than one missing tooth per quadrant, excluding 3rd molars.
- Subjects will be able to sign the informed consent form.
Exclusion Criteria:
- 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.
- Subjects receiving periodontal surgery of any type prior to Baseline examination.
- Subjects with dental implants.
- Subjects with a compromised heart condition, history of rheumatic fever, or joint replacement requiring prophylaxis.
- Subjects having taken systemic cancer therapy and/or radiation therapy at any time
- Subjects with clinically significant acute or concurrent illness
- Subjects with clinically significant chronic illness.
- Subjects with a disease of the connective tissue.
- Subjects taking medications which are likely to cause gingival hyperplasia, within ONE MONTH prior to Baseline examination
- Subjects taking antimicrobials within ONE MONTH prior to Baseline examination
- Subjects taking non-steroidal anti-inflammatory drugs at a therapeutic dose within the TWO WEEKS prior to Baseline examination.
- Subjects taking steroids of any kind within ONE MONTH prior to baseline examination.
- Subjects taking continuous low doses of tetracycline within THREE MONTHS prior to Baseline examination
- Subjects taking an investigational drug within TWO MONTHS prior to Baseline examination
- Subjects taking or having taken bisphosphonates of any kind for any reason.
- Female, nonsterile subjects who are pregnant or lactating.
- Subjects who, in the investigator's opinion, would not comply with the study procedures.
- Smokers of any type or former smokers and subjects that take or use any nicotine product.
- Excessive alcohol intake.
- No current restorative or endodontic treatment needs
Contacts and Locations| Contact: Lyndall Erb, PhD | 650-728-1326 | lyndallerb@gmail.com |
| Contact: Dawn Bloore, DDS | 888-49-LASER |
| United States, Colorado | |
| University of Colorado | Recruiting |
| Denver, Colorado, United States, 80045 | |
| Contact: Raymond Yukna, DMD, MS 303-724-7011 | |
| Principal Investigator: Raymond Yukna, DMD, MS | |
| Study Director: | Raymund A Yukna, DMD, MS | University of Colorado Scholl of Dentistry |
| Principal Investigator: | 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 |
More Information
No publications provided
| Responsible Party: | Institute for Advanced Laser Dentistry |
| ClinicalTrials.gov Identifier: | NCT01282229 History of Changes |
| Other Study ID Numbers: | MDT MC 06-001 |
| Study First Received: | January 13, 2011 |
| Last Updated: | May 16, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Institute for Advanced Laser Dentistry:
|
LANAP, Laser dentistry |
Additional relevant MeSH terms:
|
Periodontitis Chronic Periodontitis Periodontal Diseases Mouth Diseases Stomatognathic Diseases |
ClinicalTrials.gov processed this record on May 21, 2013