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

Primary Purpose

Chronic Periodontitis

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

LANAP

About this trial

This is an interventional treatment trial for Chronic Periodontitis focused on measuring LANAP, Laser dentistry

Eligibility Criteria

25 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Colorado

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

No Intervention

Arm Label

LANAP Quadrant

Modified Widman Flap

Scaling and Root Planing

Coronal Debridement

Arm Description

Treated with LANAP

Quadrant treated with Modified Widman Flap surgery

Quadrant treated with scaling and root planing alone

Quadrant treated with coronal debridement

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in Probing Depth (PD)

Positive numbers indicate average decrease in probing depth (improvement).

Change in Bleeding on Probing (BOP)

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.

Change in Gingival Index

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.

Discomfort

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.

Full Information

NCT ID

NCT01282229

First Posted

January 13, 2011

Last Updated

September 15, 2015

Sponsor

Institute for Advanced Laser Dentistry

1. Study Identification

Unique Protocol Identification Number

NCT01282229

Brief Title

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

Acronym

LANAP

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

2. Study Status

Record Verification Date

September 2015

Overall Recruitment Status

Completed

Study Start Date

October 2010 (undefined)

Primary Completion Date

March 2014 (Actual)

Study Completion Date

October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Institute for Advanced Laser Dentistry

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Periodontitis

Keywords

LANAP, Laser dentistry

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

InvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

59 (Actual)

8. Arms, Groups, and Interventions

Arm Title

LANAP Quadrant

Arm Type

Active Comparator

Arm Description

Treated with LANAP

Arm Title

Modified Widman Flap

Arm Type

No Intervention

Arm Description

Quadrant treated with Modified Widman Flap surgery

Arm Title

Scaling and Root Planing

Arm Type

No Intervention

Arm Description

Quadrant treated with scaling and root planing alone

Arm Title

Coronal Debridement

Arm Type

No Intervention

Arm Description

Quadrant treated with coronal debridement

Intervention Type

Device

Intervention Name(s)

LANAP

Other Intervention Name(s)

Periolase MVP 7

Intervention Description

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

Primary Outcome Measure Information:

Title

Gain in Clinical Attachment Level of Periodontal Tissues

Description

Time Frame

Baseline, 6, 12 months

Secondary Outcome Measure Information:

Title

Change in Probing Depth (PD)

Description

Positive numbers indicate average decrease in probing depth (improvement).

Time Frame

Baseline, 6, 12 months

Title

Change in Bleeding on Probing (BOP)

Description

Time Frame

Baseline, 6, 12 months

Title

Change in Gingival Index

Description

Time Frame

Baseline, 6, 12 months

Title

Discomfort

Description

Time Frame

1-7 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

25 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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 < 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

Overall Study Officials: