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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Institute for Advanced Laser Dentistry
ClinicalTrials.gov Identifier:
NCT01282229
First received: January 13, 2011
Last updated: October 8, 2013
Last verified: October 2013
  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

Further study details as provided by Institute for Advanced Laser Dentistry:

Primary Outcome Measures:
  • 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 2014
Estimated Primary Completion Date: March 2014 (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
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01282229

Locations
United States, Colorado
University of Colorado
Denver, Colorado, United States, 80045
Sponsors and Collaborators
Institute for Advanced Laser Dentistry
Investigators
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: October 8, 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 October 19, 2014