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

Not Applicable

Active, not recruiting

• Conditions: Periodontitis
• Interventions: Device: LANAP surgical protocol using diode 940 laser; Procedure: Scaling and root planing (SRP)

• Registration Number: NCT06509412
• Lead Sponsor: Nada Shaban

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

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-01
• Status Verified: 2024-07
• Study First Submitted: 2024-07-14
• Study First Submitted QC: 2024-07-14
• Last Update Submitted: 2024-07-14
• Study First Posted: 2024-07-19
• Last Update Posted: 2024-07-19
• Primary Completion: 2024-09
• Study Completion: 2024-09

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

• 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%.

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LANAP surgical protocol using diode 940 laser	LANAP surgical protocol using diode 940 laser	-
Scaling and root planing	Scaling and root planing (SRP)	-

Primary Outcome Measures

Name	Time	Method
Clinical attachment loss (CAL)	up to six 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).
Pocket probing depth (PPD)	up to six 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.
Microbiological assessment of Treponima denticola	up to six months	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.
Microbiological assessment of Prevotella intermedia	up to six months	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.
Gingival health	up to six months	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

Trial Locations

Locations (1)

Faculty of Dentistry, Alexandria University; 🇪🇬 Alexandria, Egypt