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

NCT01282229 | Completed Results

• 1 other identifier: MDT MC 06-001
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Periodontitis

Keywords

LANAP, Laser dentistry

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Change in Probing Depth (PD)

  Baseline, 6, 12 months

• Change in Bleeding on Probing (BOP)

  Baseline, 6, 12 months

• Change in Gingival Index

  Baseline, 6, 12 months

• Discomfort

  1-7 days

Study Arms (4)

LANAP Quadrant

ACTIVE COMPARATOR

Treated with LANAP

Device: 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

Interventions

LANAP DEVICE

Laser Assisted New Attachment Procedure (LANAP protocol) using the FR Pulsed Nd:YAG laser

Also known as: Periolase MVP 7

LANAP Quadrant

Eligibility Criteria

• Age: 25 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institute for Advanced Laser Dentistry: lead

Study Sites (1)

University of Colorado

Denver, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Chronic Periodontitis

Condition Hierarchy (Ancestors)

Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. David Harris
• Organization: Millenium Dental Technologies, Inc

dharris@LANAP.com

510-502-3345

Study Officials

• 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

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2011
• First Posted: January 24, 2011
• Study Start: October 1, 2010
• Primary Completion: March 1, 2014
• Study Completion: October 1, 2014
• Last Updated: October 14, 2015
• Results First Posted: October 14, 2015

Record last verified: 2015-09

Locations

US (1)