Clinical trial NCT01282229: Study to Compare Laser Assisted New Attachment Procedure (LANAP) to Traditional Treatments of Chronic Periodontitis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Periodontitis
Keywords: LANAP, Laser dentistry
Lead sponsor: Institute for Advanced Laser Dentistry
Sponsor class: OTHER
First posted: 2011-01-24
Enrollment: 59
Sex: ALL
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Gain in Clinical Attachment Level of Periodontal Tissues
timeFrame: Baseline, 6, 12 months
Secondary outcomes:
measure: Change in Probing Depth (PD)
timeFrame: Baseline, 6, 12 months
measure: Change in Bleeding on Probing (BOP)
timeFrame: Baseline, 6, 12 months
measure: Change in Gingival Index
timeFrame: Baseline, 6, 12 months
measure: Discomfort
timeFrame: 1-7 days
Other outcomes:
Locations:
city: Denver
country: United States
facility: University of Colorado
state: Colorado
Study officials:
affiliation: University of Colorado Scholl of Dentistry
name: Raymund A Yukna, DMD, MS
role: STUDY_DIRECTOR
affiliation: University of Louisville, School of Dentistry
name: Henry Greenwell, DMD. MSD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Maryland, School of Dentistry
name: Mark Reynolds, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Finley Periodontics
name: James Finley, DMD
role: PRINCIPAL_INVESTIGATOR
affiliation: McCawly & DeTure
name: Thomas McCawley, DDS
role: PRINCIPAL_INVESTIGATOR
References: