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

NCT06358937 | Recruiting

• 1 other identifier: #7/2023
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Periodontal Diseases

Outcome Measures

Primary Outcomes (3)

• 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.

  up to 6 months

• 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.

  up to 6 months

• 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.

  up to 6 months

Secondary Outcomes (4)

• Gingival index

  up to 6 months

• Plaque index

  up to 6 months

• Clinical attachment loss

  up to 6 months

• Probing depth

  up to 6 months

Study Arms (3)

Laser Assisted New Attachment Procedure using ND:YAG laser

EXPERIMENTAL

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

Laser Assisted New Attachment Procedure using diode laser

EXPERIMENTAL

Device: Laser Assisted New Attachment Procedure using diode laser

Scaling and Root Planing using ultrasonic and curettes

ACTIVE COMPARATOR

Procedure: Scaling and Root Planing using ultrasonic and curettes

Interventions

Laser Assisted New Attachment Procedure using ND:YAG laser DEVICE

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

Laser Assisted New Attachment Procedure using ND:YAG laser

Laser Assisted New Attachment Procedure using diode laser DEVICE

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

Laser Assisted New Attachment Procedure using diode laser

Scaling and Root Planing using ultrasonic and curettes PROCEDURE

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.

Scaling and Root Planing using ultrasonic and curettes

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mahmoud Salem: lead

Study Sites (1)

Faculty of Dentistry, Alexandria University

Alexandria, Egypt

RECRUITING

MeSH Terms

Conditions

Periodontal Diseases

Interventions

Tooth Exfoliation

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Central Study Contacts

Mahmoud Salem, BDS

CONTACT

111 144 7745; Masalem30192@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Master's candidate of Periodontology

Study Record Dates

• First Submitted: April 6, 2024
• First Posted: April 11, 2024
• Study Start: November 1, 2023
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: April 11, 2024

Record last verified: 2024-04

Locations

EG (1)