- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01282229
Study to Compare Laser Assisted New Attachment Procedure (LANAP) to Traditional Treatments of Chronic Periodontitis (LANAP)
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 Overview
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Colorado
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Denver, Colorado, United States, 80045
- University of Colorado
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 < 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.
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: LANAP Quadrant
Treated with LANAP
|
Laser Assisted New Attachment Procedure (LANAP protocol) using the FR Pulsed Nd:YAG laser
Other Names:
|
No Intervention: Modified Widman Flap
Quadrant treated with Modified Widman Flap surgery
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|
No Intervention: Scaling and Root Planing
Quadrant treated with scaling and root planing alone
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|
No Intervention: Coronal Debridement
Quadrant treated with coronal debridement
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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Baseline, 6, 12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Probing Depth (PD)
Time Frame: Baseline, 6, 12 months
|
Positive numbers indicate average decrease in probing depth (improvement).
|
Baseline, 6, 12 months
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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. |
Baseline, 6, 12 months
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Change in Gingival Index
Time Frame: Baseline, 6, 12 months
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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.
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Baseline, 6, 12 months
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Discomfort
Time Frame: 1-7 days
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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.
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1-7 days
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Collaborators and Investigators
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
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MDT MC 06-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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