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Study to Compare Laser Assisted New Attachment Procedure (LANAP) to Traditional Treatments of Chronic Periodontitis (LANAP)

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ClinicalTrials.gov Identifier: NCT01282229
Recruitment Status : Completed
First Posted : January 24, 2011
Results First Posted : October 14, 2015
Last Update Posted : October 14, 2015
Sponsor:
Information provided by (Responsible Party):
Institute for Advanced Laser Dentistry

Tracking Information
First Submitted Date  ICMJE January 13, 2011
First Posted Date  ICMJE January 24, 2011
Results First Submitted Date  ICMJE June 18, 2015
Results First Posted Date  ICMJE October 14, 2015
Last Update Posted Date October 14, 2015
Study Start Date  ICMJE October 2010
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 15, 2015)
Gain in Clinical Attachment Level of Periodontal Tissues [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 21, 2011)
Gain in Clinical Attachment Level of Periodontal Tissues [ Time Frame: 1 year ]
Change History Complete list of historical versions of study NCT01282229 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 15, 2015)
  • Change in Probing Depth (PD) [ Time Frame: Baseline, 6, 12 months ]
    Positive numbers indicate average decrease in probing depth (improvement).
  • Change in Bleeding on Probing (BOP) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Compare Laser Assisted New Attachment Procedure (LANAP) to Traditional Treatments of Chronic Periodontitis
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Chronic Periodontitis
Intervention  ICMJE Device: LANAP
Laser Assisted New Attachment Procedure (LANAP protocol) using the FR Pulsed Nd:YAG laser
Other Name: Periolase MVP 7
Study Arms  ICMJE
  • Active Comparator: LANAP Quadrant
    Treated with LANAP
    Intervention: Device: LANAP
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 15, 2015)
59
Original Estimated Enrollment  ICMJE
 (submitted: January 21, 2011)
125
Actual Study Completion Date  ICMJE October 2014
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 25 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01282229
Other Study ID Numbers  ICMJE MDT MC 06-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Institute for Advanced Laser Dentistry
Study Sponsor  ICMJE Institute for Advanced Laser Dentistry
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Institute for Advanced Laser Dentistry
Verification Date September 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP