Clinical and Microbiological Evaluation of Laser Assisted New Attachment Procedure (LANAP) Using Nd:Yag vs. Diode Laser in the Management Of Stage II Periodontitis

April 6, 2024 updated by: Mahmoud Salem

Clinical and Microbiological Evaluation of Laser Assisted New Attachment Procedure (LANAP) Using Nd:Yag vs. Diode Laser in the Management Of Stage II Periodontitis (Randomized Controlled Clinical Trial)

The aim of the present study is to compare the efficacy of LANAP to conventional scaling and root planing in the management of stage II periodontitis.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
27

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Egypt
      • Alexandria, Egypt
        • Recruiting
        • Faculty of Dentistry, Alexandria University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients with stage II generalized periodontitis PPD ≥ 5 mm with attachment loss 3-4 mm with horizontal bone loss

Exclusion Criteria:

  • Patients with vertical bone loss or furcation involvement.
  • History of smoking more than (10 cigarettes / day).
  • Patient with medical condition that contraindicate surgical procedures.
  • Patients receiving antibiotics in the past three months prior to the procedure.
  • Pregnant or lactating females.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Laser Assisted New Attachment Procedure using ND:YAG laser
Device: Laser Assisted New Attachment Procedure using ND:YAG laser
A free running, pulsed, 1064 nm wavelength-specific ND:YAG laser will be used. A thin 300 μm laser fiber optic will be placed parallel to the root surface, allows easy access into deep periodontal pockets. The initial pass with the laser is known as Laser Troughing, and it is done with a micro-short duration pulse, with a 4.0 watt power, 150 μs duration in pulsed mode and 20Hz frequency. Ultrasonic scaler will be then used to remove calculus. The second pass is carried out with 650 μs pulse duration, 10-30 seconds for each tooth, 4.0 watt power and 20HZ frequency, to improve the ability to generate a fibrin clot. The fibrin clot is then compressed. Relieving the occlusion is the last step of the LANAP protocol.
Other Names:
  • LANAP using ND:YAG laser
Experimental: Laser Assisted New Attachment Procedure using diode laser
Device: Laser Assisted New Attachment Procedure using diode laser

Diode laser (Biolase) with 940 nm wavelength, a thin flexible fiber-optic cable 300 μm attached with a power average set at 0.5-1.5 watt will be used.

The first pass "laser troughing" is done using a thin flexible fiber-optic cable 300 μm placed parallel to the root surface, attached with a power average set at 0.5-1 watt, in continuous mode. Ultrasonic scaler will be then used to remove calculus which present on the root surface. The second pass is carried out with 1-1.5 watt power in continuous mode, 10-30 seconds for each tooth, and, to improve the ability to generate a fibrin clot. The fibrin clot is then compressed in order to enhance the healing

Other Names:
  • LANAP using diode laser
Active Comparator: Scaling and Root Planing using ultrasonic and curettes
Procedure: Scaling and Root Planing using ultrasonic and curettes
Scaling and root planing (SRP) using ultrasonic device at a moderate setting and with the appropriate tips and curettes will be also used where indicated and time spent in SRP on each tooth will not be restricted.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Microbiological assessment of Fusobacterium nucleatum
Time Frame: up to 6 months
Subgingival plaque biofilm will be collected using paper cone after making a good isolation of the operated field and put into a sterile microcentrifuge tube containing phosphate buffered saline to be transferred immediately to the Microbiology laboratory for analysis of microbiome. Microcentrifuge tubes will be vortexed for 5 minutes then 200 ul of the resulting suspension will be subjected to DNA extraction using QIAamp DNA minikit. Specific PCR primers targeting gingival plaque associated oral microbiota (Fusobacterium nucleatum) will be used in SYBR Green Real-Time PCR. Amplification of 16SrRNA gene will be used as the denominator against which the amplification of other bacteria will be estimated. The bacterial relative quantification will be calculated automatically by the Rotor-Gene software and expressed as relative fold difference.
up to 6 months
Microbiological assessment of Porphyromonas gingivalis
Time Frame: up to 6 months
Subgingival plaque biofilm will be collected using paper cone after making a good isolation of the operated field and put into a sterile microcentrifuge tube containing phosphate buffered saline to be transferred immediately to the Microbiology laboratory for analysis of microbiome. Microcentrifuge tubes will be vortexed for 5 minutes then 200 ul of the resulting suspension will be subjected to DNA extraction using QIAamp DNA minikit. Specific PCR primers targeting gingival plaque associated oral microbiota (Porphyromonas gingivalis) will be used in SYBR Green Real-Time PCR. Amplification of 16SrRNA gene will be used as the denominator against which the amplification of other bacteria will be estimated. The bacterial relative quantification will be calculated automatically by the Rotor-Gene software and expressed as relative fold difference.
up to 6 months
Microbiological assessment of Tannerella forsythia
Time Frame: up to 6 months
Subgingival plaque biofilm will be collected using paper cone after making a good isolation of the operated field and put into a sterile microcentrifuge tube containing phosphate buffered saline to be transferred immediately to the Microbiology laboratory for analysis of microbiome. Microcentrifuge tubes will be vortexed for 5 minutes then 200 ul of the resulting suspension will be subjected to DNA extraction using QIAamp DNA minikit. Specific PCR primers targeting gingival plaque associated oral microbiota (Tannerella forsythia) will be used in SYBR Green Real-Time PCR. Amplification of 16SrRNA gene will be used as the denominator against which the amplification of other bacteria will be estimated. The bacterial relative quantification will be calculated automatically by the Rotor-Gene software and expressed as relative fold difference.
up to 6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Gingival index
Time Frame: up to 6 months
This is used to assess the degree of gingival inflammation. Each tooth is examined and scored (0-3), where 0 = normal gingiva; 1 = mild inflammation: slight change in color, slight edema, no bleeding on probing; 2 = moderate inflammation: redness, edema, and glazing, or bleeding on probing; 3 = severe inflammation: marked redness and edema, tendency toward spontaneous bleeding and ulceration
up to 6 months
Plaque index
Time Frame: up to 6 months
This is used to assess the amount of plaque accumulation. Each tooth is examined and scored (0-3), where 0= no plaque, 1= a thin plaque film at the free gingival margin (only seen by running a probe in the sulcus, 2= moderate plaque accumulation, 3= abundance of plaque
up to 6 months
Clinical attachment loss
Time Frame: up to 6 months
This is assessed using a Williams probe from a fixed reference point on the crown to the base of the pocket. Pocket severity is classified by the extent of clinical attachment loss in millimeters (0= normal, 1 or 2 mm = slight, 3 or 4 mm = moderate, ≥ 5 mm = severe).
up to 6 months
Probing depth
Time Frame: up to 6 months
This is measured from the margin of the gingiva to the base of the pocket using a Williams probe. The normal probing sulcus depth is considered to range from 1 to 3 mm in healthy gingiva.
up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mahmoud Salem

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 6, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 6, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 11, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 11, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 6, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • #7/2023

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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