Chronic PeriodontitisLANAPNCT01282229
Study to Compare Laser Assisted New Attachment Procedure (LANAP) to Traditional Treatments of Chronic Periodontitis
A study testing LANAP in people with Chronic Periodontitis, run by Institute for Advanced Laser Dentistry at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 25 to 75 years
- Conditions the study is for
- Chronic Periodontitis
- What is being tested?
- LANAP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Oct 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Chronic Periodontitis
- Being tested
- LANAP
- Keywords
- LANAP, Laser dentistry
- Medical subject headings
- Chronic Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LANAPDevice
Also called Periolase MVP 7
Laser Assisted New Attachment Procedure (LANAP protocol) using the FR Pulsed Nd:YAG laser
| Study group | Role | What they receive |
|---|---|---|
| LANAP Quadrant | Active comparator | Treated with LANAP Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 6, 12 months
Secondary outcomes (4)
Change in Probing Depth (PD)
Positive numbers indicate average decrease in probing depth (improvement).
Measured: Baseline, 6, 12 months
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.
Measured: Baseline, 6, 12 months
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.
Measured: Baseline, 6, 12 months
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.
Measured: 1-7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2011 (estimated)
- Study startOct 2010
- Primary completionMar 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic PeriodontitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute for Advanced Laser Dentistry
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Raymund A Yukna, DMD, MS, Study director, University of Colorado Scholl of DentistryHenry Greenwell, DMD. MSD, Principal investigator, University of Louisville, School of DentistryMark Reynolds, DDS, PhD, Principal investigator, University of Maryland, School of DentistryJames Finley, DMD, Principal investigator, Finley PeriodonticsThomas McCawley, DDS, Principal investigator, McCawly & DeTure
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01282229
- Sponsor's protocol ID
- MDT MC 06-001
- Acronym
- LANAP
- Status last verified
- Sep 2015
- First submitted
- 13 Jan 2011
- Last updated
- 14 Oct 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01282229
- Acronym / sponsor ID
- LANAP / MDT MC 06-001
- Conditions
- Chronic Periodontitis
- Keywords
- LANAP, Laser dentistry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Institute for Advanced Laser DentistryUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Mar 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 24 Jan 2011 (estimated)
- Results
- Posted 14 Oct 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| LANAP Quadrant | Active comparator | Device: LANAPTreated with 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 |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LANAPAlso: Periolase MVP 7Laser Assisted New Attachment Procedure (LANAP protocol) using the FR Pulsed Nd:YAG laser | Device | LANAP Quadrant |
Primary outcome
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.
4 secondary outcomes
Change in Probing Depth (PD)
Time frame: Baseline, 6, 12 months
Change in Bleeding on Probing (BOP)
Time frame: Baseline, 6, 12 months
Change in Gingival Index
Time frame: Baseline, 6, 12 months
Discomfort
Time frame: 1-7 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raymund A Yukna, DMD, MS study director
University of Colorado Scholl of Dentistry
Henry Greenwell, DMD. MSD principal investigator
University of Louisville, School of Dentistry
Mark Reynolds, DDS, PhD principal investigator
University of Maryland, School of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LANAP in people with Chronic Periodontitis, run by Institute for Advanced Laser Dentistry at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Oct 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gain in Clinical Attachment Level of Periodontal Tissues (time frame: Baseline, 6, 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2015.