PeriodontitisNCT06509412
Nd:YAG Laser Versus Diode Laser Assisted New Attachment Procedure (Lanap) in the Management of Stage II Periodontitis
A study testing LANAP surgical protocol using ND:YAG 1064 laser, LANAP surgical protocol using diode 940 laser and Scaling and root planing (SRP) in people with Periodontitis, run by Nada Shaban at 1 site in Egypt.
Trial 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 Read more about this study
- Who is it for?
- Ages 30 to 50 years
- Conditions the study is for
- Periodontitis
- What is being tested?
- LANAP surgical protocol using ND:YAG 1064 laser, LANAP surgical protocol using diode 940 laser and Scaling and root planing (SRP)
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2024to 17 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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%.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Conditions
- Periodontitis
- Being tested
- LANAP surgical protocol using ND:YAG 1064 laser, LANAP surgical protocol using diode 940 laser, Scaling and root planing (SRP)
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LANAP surgical protocol using ND:YAG 1064 laserDevice
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 diode 940 laserDevice
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
Scaling and root planing (SRP)Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| LANAP surgical protocol using ND:YAG 1064 laser | Experimental | Not described Receives: Device: LANAP surgical protocol using ND:YAG 1064 laser |
| LANAP surgical protocol using diode 940 laser | Experimental | Not described Receives: Device: LANAP surgical protocol using diode 940 laser |
| Scaling and root planing | Active comparator | Not described Receives: Procedure: Scaling and root planing (SRP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: 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).
Measured: 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.
Measured: up to six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2024
- Study start1 Jan 2024
- Primary completion15 Sep 2025
- Study completion17 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nada Shaban
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nada Shaban, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06509412
- Sponsor's protocol ID
- 2/2023
- Status last verified
- Mar 2026
- First submitted
- 14 Jul 2024
- Last updated
- 10 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Shaban NW, Kotry GS, Taalab MR, Meheissen MA, Grzech-Lesniak K. 1064 nm Nd:YAG versus 940 nm diode laser-assisted periodontal therapy in stage II periodontitis: a randomized controlled trial. BMC Oral Health. 2026 Jun 1;26(1):1205. doi: 10.1186/s12903-026-08676-x.
PubMed 42226208
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nd:YAG Laser Versus Diode Laser Assisted New Attachment Procedure (Lanap) in the Management of Stage II Periodontitis: Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06509412
- Acronym / sponsor ID
- 2/2023
- Conditions
- Periodontitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Nada ShabanUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 15 Sep 2025 (actual)
- Study completion
- 17 Dec 2025 (actual)
- First posted
- 19 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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%.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LANAP surgical protocol using ND:YAG 1064 laserA 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 | Device | LANAP surgical protocol using ND:YAG 1064 laser |
| LANAP surgical protocol using diode 940 laserDiode 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 | Device | LANAP surgical protocol using diode 940 laser |
| Scaling and root planing (SRP)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. | Procedure or surgery | Scaling and root planing |
Primary outcome
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.
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.
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
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).
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
- Derived from this study: PubMed 42226208Shaban NW, Kotry GS, Taalab MR, Meheissen MA, Grzech-Lesniak K. 1064 nm Nd:YAG versus 940 nm diode laser-assisted periodontal therapy in stage II periodontitis: a randomized controlled trial. BMC Oral Health. 2026 Jun 1;26(1):1205. doi: 10.1186/s12903-026-08676-x.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LANAP surgical protocol using ND:YAG 1064 laser, LANAP surgical protocol using diode 940 laser and Scaling and root planing (SRP) in people with Periodontitis, run by Nada Shaban at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microbiological assessment of Treponima denticola (time frame: up to six months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06509412, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2026.