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

Periodontal Diseases Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06358937
• Other study ID #: #7/2023
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2023
• Est. completion date: May 2024

Study information

• Verified date: April 2024
• Source: Alexandria University
• Contact: Mahmoud Salem, BDS
• Phone: 111 144 7745
• Email: Masalem30192[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 27
• Est. completion date: May 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Periodontal Diseases
• Periodontitis

Intervention

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.
• 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

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.

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry, Alexandria University	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Mahmoud Salem

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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	up to 6 months
Secondary	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	up to 6 months
Secondary	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).	up to 6 months
Secondary	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.	up to 6 months