Nd:YAG Laser Versus Diode Laser Assisted New Attachment Procedure (Lanap) in the Management of Stage II Periodontitis

NCT06509412 | Completed

• 1 other identifier: 2/2023
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

Aim of the study was to assess and compare the clinical and microbiological changes following Laser assisted new attachment procedure (LANAP®) using diode 940 nm versus ND:YAG 1064 nm, and to compare the outcome to conventional periodontal therapy

Conditions

Periodontitis

Outcome Measures

Primary Outcomes (5)

• Microbiological assessment of Treponima denticola

  Sub-gingival dental plaque biofilm will be collected using size 50 paper point after ensuring a good isolation of the operating field, and sample will be placed in sterile microcentrifuge tubes containing phosphate buffered saline to be transferred immediately to the Microbiology Laboratory of Alexandria University Hospitals. Microcentrifuge tubes will be vortexed for 5 minutes then 200 ul of resulting suspension will be subjected to DNA extraction using QIAamp DNA Minikit (Qiagen, Germany). Specific PCR primers targeting gingival plaque-associated oral microbiota (Treponima denticola Td) will be used in SYBER green real-time PCR. Amplification of the 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 Rotor-gene software and expressed as relative fold difference.

  up to six months

• Microbiological assessment of Prevotella intermedia

  Sub-gingival dental plaque biofilm will be collected using size 50 paper point after ensuring a good isolation of the operating field, and sample will be placed in sterile microcentrifuge tubes containing phosphate buffered saline to be transferred immediately to the Microbiology Laboratory of Alexandria University Hospitals. Microcentrifuge tubes will be vortexed for 5 minutes then 200 ul of resulting suspension will be subjected to DNA extraction using QIAamp DNA Minikit (Qiagen, Germany). Specific PCR primers targeting gingival plaque-associated oral microbiota (Prevotella intermedia Pi) will be used in SYBER green real-time PCR. Amplification of the 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 Rotor-gene software and expressed as relative fold difference.

  up to six months

• Gingival health

  The gingival index (Löe and Silness,1967) will be 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 six months

• Clinical attachment loss (CAL)

  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 six months

• Pocket probing depth (PPD)

  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 six months

Study Arms (3)

LANAP surgical protocol using ND:YAG 1064 laser

EXPERIMENTAL

Device: LANAP surgical protocol using ND:YAG 1064 laser

LANAP surgical protocol using diode 940 laser

EXPERIMENTAL

Device: LANAP surgical protocol using diode 940 laser

Scaling and root planing

ACTIVE COMPARATOR

Procedure: Scaling and root planing (SRP)

Interventions

LANAP surgical protocol using diode 940 laser DEVICE

Diode laser (Biolase) with 940 nm wavelength, a thin flexible fiber-optic cable 300 μm was attached with a power average set at 0.5-1 watt, in continuous mode, and 20 HZ

LANAP surgical protocol using diode 940 laser

Scaling and root planing (SRP) PROCEDURE

Scaling and root planing (SRP) using ultrasonic device (Woodpecker USD-P Led Ultrasonic Scaler Ende) at moderate setting and with appropriate tips and also hand curettes will be used for root planning.

Scaling and root planing

LANAP surgical protocol using ND:YAG 1064 laser DEVICE

A free running pulsed, 1064 nm wavelength-specific ND:YAG laser (Light walker AT)\* with an attached 320 µm diameter optical glass fiber attached to a metallic hand piece with a flexible tip, which will be set at 3:4 -watt average power, 20 HZ, and a 100-600 µs pulse duration

LANAP surgical protocol using ND:YAG 1064 laser

Eligibility Criteria

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

You may qualify if:

• Periodontal diagnosis of stage II periodontitis.
• Residual periodontal pocket ≥4 mm, 3-4 mm clinical attachment loss with horizontal bone loss higher than 15% in radiography.
• O'Leary plaque index \<10%.

You may not qualify if:

• Patients with furcation involvement.
• Class II/III tooth mobility.
• Smokers who smoke more than 10 cigarettes per day.
• Patients with any systemic condition possibly affecting the outcome of periodontal therapy.
• Patients who had received any local or systemic anti-inflammatory medications or antibiotics within the last 6 months.
• Alcohol consumers.
• Pregnant or lactating women.
• Patients with parafunctional habits.

Sponsors & Collaborators

• Nada Shaban: lead

Study Sites (1)

Faculty of Dentistry, Alexandria University

Alexandria, Egypt

Location

MeSH Terms

Conditions

Periodontitis

Interventions

Tooth Exfoliation; Root Planing

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena; Dental Scaling; Dental Prophylaxis; Periodontics; Dentistry; Subgingival Curettage; Preventive Dentistry

Study Design

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

Study Record Dates

• First Submitted: July 14, 2024
• First Posted: July 19, 2024
• Study Start: January 1, 2024
• Primary Completion: September 15, 2025
• Study Completion: December 17, 2025
• Last Updated: March 10, 2026

Record last verified: 2026-03

Locations

EG (1)