Periodontal DiseasesNCT06358937
Clinical and Microbiological Evaluation of Laser Assisted New Attachment Procedure (LANAP) Using Nd:Yag vs. Diode Laser in the Management Of Stage II Periodontitis
A study testing Laser Assisted New Attachment Procedure using ND:YAG laser, Laser Assisted New Attachment Procedure using diode laser and Scaling and Root Planing using ultrasonic and curettes in people with Periodontal Diseases, run by Mahmoud Salem at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 30 to 50 years
- Conditions the study is for
- Periodontal Diseases
- What is being tested?
- Laser Assisted New Attachment Procedure using ND:YAG laser, Laser Assisted New Attachment Procedure using diode laser and Scaling and Root Planing using ultrasonic and curettes
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2023to May 2024
- 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
- Patients with stage II generalized periodontitis PPD ≥ 5 mm with attachment loss 3-4 mm with horizontal bone loss
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Dentistry, Alexandria University
Alexandria
Mahmoud Salem, BDS, 111 144 7745 ext. +20, Masalem30192@gmail.com
About this study
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)
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.
- Conditions
- Periodontal Diseases
- Being tested
- Laser Assisted New Attachment Procedure using ND:YAG laser, Laser Assisted New Attachment Procedure using diode laser, Scaling and Root Planing using ultrasonic and curettes
- Medical subject headings
- Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser Assisted New Attachment Procedure using ND:YAG laserDevice
Also called LANAP 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 laserDevice
Also called LANAP 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
Scaling and Root Planing using ultrasonic and curettesProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Laser Assisted New Attachment Procedure using ND:YAG laser | Experimental | Not described Receives: Device: Laser Assisted New Attachment Procedure using ND:YAG laser |
| Laser Assisted New Attachment Procedure using diode laser | Experimental | Not described Receives: Device: Laser Assisted New Attachment Procedure using diode laser |
| Scaling and Root Planing using ultrasonic and curettes | Active comparator | Not described Receives: Procedure: Scaling and Root Planing using ultrasonic and curettes |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 6 months
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.
Measured: up to 6 months
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.
Measured: up to 6 months
Secondary outcomes (4)
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
Measured: up to 6 months
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
Measured: up to 6 months
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).
Measured: up to 6 months
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.
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2024
- Study start1 Nov 2023
- Primary completionMay 2024 (estimated)
- Study completionMay 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseasesStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahmoud Salem
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mahmoud Salem, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06358937
- Sponsor's protocol ID
- #7/2023
- Status last verified
- Apr 2024
- First submitted
- 6 Apr 2024
- Last updated
- 11 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT06358937
- Acronym / sponsor ID
- #7/2023
- Conditions
- Periodontal Diseases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- Mahmoud SalemUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- May 2024 (estimated)
- Study completion
- May 2024 (estimated)
- First posted
- 11 Apr 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Laser Assisted New Attachment Procedure using ND:YAG laser | Experimental | Device: Laser Assisted New Attachment Procedure using ND:YAG laser |
| Laser Assisted New Attachment Procedure using diode laser | Experimental | Device: Laser Assisted New Attachment Procedure using diode laser |
| Scaling and Root Planing using ultrasonic and curettes | Active comparator | Procedure: Scaling and Root Planing using ultrasonic and curettes |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients with stage II generalized periodontitis PPD ≥ 5 mm with attachment loss 3-4 mm with horizontal bone loss
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| Laser Assisted New Attachment Procedure using ND:YAG laserAlso: LANAP using ND:YAG laserA 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. | Device | Laser Assisted New Attachment Procedure using ND:YAG laser |
| Laser Assisted New Attachment Procedure using diode laserAlso: LANAP using diode laserDiode 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 | Device | Laser Assisted New Attachment Procedure using diode laser |
| Scaling and Root Planing using ultrasonic and curettesScaling 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. | Procedure or surgery | Scaling and Root Planing using ultrasonic and curettes |
Primary outcome
Microbiological assessment of Fusobacterium nucleatum
Time frame: up to 6 months
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.
Microbiological assessment of Porphyromonas gingivalis
Time frame: up to 6 months
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.
Microbiological assessment of Tannerella forsythia
Time frame: up to 6 months
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.
4 secondary outcomes
Gingival index
Time frame: up to 6 months
Plaque index
Time frame: up to 6 months
Clinical attachment loss
Time frame: up to 6 months
Probing depth
Time frame: up to 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2024.
Related trials for Periodontal Diseases
Not yet recruitingObservational study
Periodontal Status and Biomarkers in MASLD
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Recruiting
Thermosensitive Hyaluronic Gel With Octenidine as an Adjunctive to Subgingival Instrumentation
Periodontal Disease
Active, not recruitingObservational study
A Retrospective Comparative Evaluation of Omega-3 and Resveratrol Supplementation in Patients With Periodontitis
Periodontitis
Recruiting
Effects of Different Activation Techniques on Antimicrobial Photodynamic Therapy in Apical Periodontitis
Apical Periodontitis, Endodontic Retreatment
Recruiting
Ozone Gel Versus Chlorohexidine Gel as an Adjunct to Non-Surgical Treatment of Stage II Periodontitis Grade B Among Smokers Patients
Ozone Gel, Chlorohexidine Gel
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laser Assisted New Attachment Procedure using ND:YAG laser, Laser Assisted New Attachment Procedure using diode laser and Scaling and Root Planing using ultrasonic and curettes in people with Periodontal Diseases, run by Mahmoud Salem 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 1 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 11 Apr 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mahmoud Salem, BDS (111 144 7745 ext. +20, Masalem30192@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microbiological assessment of Fusobacterium nucleatum (time frame: up to 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Apr 2024.