ClinicalTrials.gg
Status unknownNCT06358937Updated Apr 11, 2024

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

An interventional study of Laser Assisted New Attachment Procedure using ND:YAG laser and Laser Assisted New Attachment Procedure using diode laser in Periodontal Diseases, sponsored by Mahmoud Salem. Status unknown at 1 site in Egypt. Open to participants aged 30 Years to 50 Years. Per ClinicalTrials.gov, last updated 2024-04-11.

Sponsored by Mahmoud Salem · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2024), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Nov 2023, registered Apr 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
27
Allocation
Randomized
Ages
30 Years to 50 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Periodontal Diseases

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03

In context

Periodontal Diseases

855 studies on the registry are indexed under Periodontal Diseases; 189 are open to participants now.

This study's planned enrollment of 27 is below the median of 45 across 546 interventional studies indexed under Periodontal Diseases.

Browse Periodontal Diseases studies →

Lead sponsor

This is the only study on the registry with Mahmoud Salem as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
27 participants (estimated)

Study arms

  • Experimental
    Laser Assisted New Attachment Procedure using ND:YAG laser

    Device: Laser Assisted New Attachment Procedure using ND:YAG laser

  • Experimental
    Laser Assisted New Attachment Procedure using diode laser

    Device: Laser Assisted New Attachment Procedure using diode laser

  • Active comparator
    Scaling and Root Planing using ultrasonic and curettes

    Procedure: Scaling and Root Planing using ultrasonic and curettes

Interventions

  • DeviceLaser 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.

    Also known as: LANAP using ND:YAG laser

  • DeviceLaser 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

    Also known as: LANAP using diode laser

  • ProcedureScaling 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.

06

What researchers measure

Primary outcomes

  1. Microbiological assessment of Fusobacterium nucleatum

    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.

    Time frame: up to 6 months

  2. Microbiological assessment of Porphyromonas gingivalis

    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.

    Time frame: up to 6 months

  3. Microbiological assessment of Tannerella forsythia

    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.

    Time frame: up to 6 months

Secondary outcomes

  1. Gingival index

    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

    Time frame: up to 6 months

  2. Plaque index

    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

    Time frame: up to 6 months

  3. Clinical attachment loss

    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).

    Time frame: up to 6 months

  4. Probing depth

    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.

    Time frame: up to 6 months

07

Study locations

1 of 1 sites recruiting
  • Faculty of Dentistry, Alexandria University
    Alexandria, Egypt
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 11, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06358937
Lead sponsor
Mahmoud Salem
Responsible party
Mahmoud Salem (Master's candidate of Periodontology, Alexandria University) — Sponsor-investigator
First posted
Apr 11, 2024
Start date
Nov 1, 2023
Primary completion
May 2024 (estimated)
Completion
May 2024 (estimated)
Last update
Apr 11, 2024

Study contacts

Mahmoud Salem, BDS
Contact
Masalem30192@gmail.com
111 144 7745 ext. +20

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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