N/A
N=59
Study to Compare Laser Assisted New Attachment Procedure (LANAP) to Traditional Treatments of Chronic Periodontitis
Chronic Periodontitis
Bottom Line
View on ClinicalTrials.gov: NCT01282229 ↗Enrolled (actual)
59
Serious AEs
0.0%
Results posted
Oct 2015
Primary outcome: Primary: Gain in Clinical Attachment Level of Periodontal Tissues — 1.361; 2.387; 1.180; 2.329 mm
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- LANAP (Device)
- Age
- Adult, Older Adult · 25+ yrs
- Sex
- All
- Sponsor
- Institute for Advanced Laser Dentistry
- Primary completion
- Mar 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Gain in Clinical Attachment Level of Periodontal Tissues |
1.361; 2.387; 1.180; 2.329; 1.347; 2.061 | — |
| SECONDARY Change in Probing Depth (PD) |
1.674; 1.834; 1.550; 1.084; 1.888; 1.831 | — |
| SECONDARY Change in Bleeding on Probing (BOP) |
-24.9; -22.9; -23.7; -18.0; -23.0; -20.4 | — |
| SECONDARY Change in Gingival Index |
-1.28; -1.30; -1.28; -1.14; -1.29; -1.27 | — |
| SECONDARY Discomfort |
10; 19; 4.4; 3.5 | — |
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.
Eligibility Criteria
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 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
Data sourced from ClinicalTrials.gov (NCT01282229). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.