- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06509412
Nd:YAG Laser Versus Diode Laser Assisted New Attachment Procedure (Lanap) in the Management of Stage II Periodontitis
March 7, 2026 updated by: Nada Shaban
Nd:YAG Laser Versus Diode Laser Assisted New Attachment Procedure (Lanap) in the Management of Stage II Periodontitis: Randomized Controlled Clinical Trial
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
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
33
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Alexandria, Egypt
- Faculty of Dentistry, Alexandria University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Scaling and root planing
|
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.
|
|
Experimental: LANAP surgical protocol using ND:YAG 1064 laser
|
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
|
|
Experimental: LANAP surgical protocol using diode 940 laser
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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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Microbiological assessment of Treponima denticola
Time Frame: 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.
|
up to six months
|
|
Microbiological assessment of Prevotella intermedia
Time Frame: 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.
|
up to six months
|
|
Gingival health
Time Frame: 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
|
up to six months
|
|
Clinical attachment loss (CAL)
Time Frame: 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).
|
up to six months
|
|
Pocket probing depth (PPD)
Time Frame: 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.
|
up to six months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2024
Primary Completion (Actual)
September 15, 2025
Study Completion (Actual)
December 17, 2025
Study Registration Dates
First Submitted
July 14, 2024
First Submitted That Met QC Criteria
July 14, 2024
First Posted (Actual)
July 19, 2024
Study Record Updates
Last Update Posted (Actual)
March 10, 2026
Last Update Submitted That Met QC Criteria
March 7, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2/2023
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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