PeriodontitisLANAP LLLTNCT04694222
Use of Laser Assisted New Attachment Procedure and Low Level Laser Therapy for Periodontitis Patients
A study testing Nd:YAG laser in people with Periodontitis, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
Trial summary
In this study, it is evaluated the effects of laser assisted new attachment procedure (LANAP) and low level laser therapy (LLLT) and on clinical, biochemical and radiographic parameters in addition to non-surgical periodontal treatment (NSPT). Read more about this study
- Who is it for?
- Ages 25 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis
- What is being tested?
- Nd:YAG laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Oct 2017to 15 Jun 2018
- 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 25 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- periodontitis of periodontal stage II, III, or IV with grades B
- with at least 12 teeth in the mouth and had ≥4 teeth but not all of them in the same quadrant
- with Probing depth of ≥5 mm, Clinical attachment level of ≥4 mm
- radiographic evidence of alveolar bone loss
Who cannot join
- smoking
- pregnancy and lactation
- using antibiotics in the last 6 months and anti-inflammatory drugs in the last 3rd months,
- having the systemic disease and the use of the drug that will affect the periodontal condition, having restoration of the adjacent tooth to be collected gingival crevicular fluid
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Efficacy of LANAP and Adjunctive LLLT Application in the Treatment of Periodontitis: A Randomized Controlled Clinical Study
In this study, it is evaluated the effects of laser assisted new attachment procedure (LANAP) and low level laser therapy (LLLT) and on clinical, biochemical and radiographic parameters in addition to non-surgical periodontal treatment (NSPT).
Read the detailed description
The study was designed as a randomized-controlled, single-blind and parallel design consisting of 80 patients with chronic periodontitis. Study consists of 4 groups, with 20 patients in each group. Group 1 received only NSPT, Group 2 received NSPT+LANAP, Group 3 received NSPT+LLLT, and Group 4 received NSPT+LANAP+LLLT. Clinical measurements of patients and gingival crevicular fluid (GCF) were taken before treatment and after 1 and 3 months. In GCF, interleukin-1beta, interleukin-10 and vascular endothelial growth factor were analyzed. Standard periapical radiographs were taken for radiographic measurements.
In moderate (4-6 mm) and deep pockets (7 mm and above), it was found that all groups treated with laser significantly decrease pocket depth (PD) and clinic attachment level (CAL) compared to Group 1. Group 3 caused significantly less gingival recession than all other groups. There was no statistical difference between the groups in biochemical markers. Radiographic analysis revealed that only Group 2 achieved significant bone filling compared to Group 1.
Bot LANAP and LLLT application in the deep pockets provide an additional contribution to NSPT. It has been found that LLLT administration leads to decrease in PD by creating a minimum recession.
- Conditions
- Periodontitis
- Being tested
- Nd:YAG laser
- Keywords
- Laser Assisted New Attachment Procedure, Low Level Laser Therapy, periodontitis, non-surgical periodontal therapy
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nd:YAG laserDevice
For LANAP, the fiber optic tip of the Nd:YAG laser (1064 nm) (Fotona Fidelis AT, USA) was used. For LLLT R24 biostimulation handpiece tip (950-μm) Nd:YAG laser (1064 nm) was used.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Other | scaling and root planning (SRP) was applied. Receives: Device: Nd:YAG laser |
| LANAP Group | Active comparator | After scaling and polishing, three LANAP stages were performed : In the first stage, Nd:YAG laser was applied. In the second stage, full mouth SRP procedure was performed. In the third stage, Nd:YAG laser was applied again. Receives: Device: Nd:YAG laser |
| LLLT Group | Active comparator | after SRP Low Level Laser Therapy was performed using Nd:YAG laser. Receives: Device: Nd:YAG laser |
| LANAP+LLLT Group | Active comparator | after scaling both LANAP and LLLT were applied. Receives: Device: Nd:YAG laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical attachment level gain
The clinical attachment level is determined by measuring the distance from the cemento-enamel junction to the gingival margin and adding the pocket depth to it.
Measured: Baseline
Clinical attachment level gain
The clinical attachment level is determined by measuring the distance from the cemento-enamel junction to the gingival margin and adding the pocket depth to it.
Measured: 1 month
Clinical attachment level gain
The clinical attachment level is determined by measuring the distance from the cemento-enamel junction to the gingival margin and adding the pocket depth to it.
Measured: 3 month
Secondary outcomes (24)
Probing depth
It is determined by measuring the distance from the gingival margin to the pocket base
Measured: Baseline
Probing depth
It is determined by measuring the distance from the gingival margin to the pocket base
Measured: 1 Month
Probing depth
It is determined by measuring the distance from the gingival margin to the pocket base
Measured: 3 Month
Gingival index
For assessing severity of gingivitis, and its location by examining qualitative changes of gingival tissues
Measured: Baseline
Gingival index
For assessing severity of gingivitis, and its location by examining qualitative changes of gingival tissues
Measured: 1 Month
Gingival index
For assessing severity of gingivitis, and its location by examining qualitative changes of gingival tissues
Measured: 3 Month
Plaque index
This index measures the thickness of plaque on gingival one third
Measured: Baseline
Plaque index
This index measures the thickness of plaque on gingival one third
Measured: 1 Month
Plaque index
This index measures the thickness of plaque on gingival one third
Measured: 3 Month
Bleeding on probing
In this index, probing is performed by gently walking around the pocket and bleeding is evaluated. As a result of probing, evaluation is made by looking at the presence or absence of bleeding in the gingiva.
Measured: Baseline
Bleeding on probing
In this index, probing is performed by gently walking around the pocket and bleeding is evaluated. As a result of probing, evaluation is made by looking at the presence or absence of bleeding in the gingiva.
Measured: 1 Month
Bleeding on probing
In this index, probing is performed by gently walking around the pocket and bleeding is evaluated. As a result of probing, evaluation is made by looking at the presence or absence of bleeding in the gingiva.
Measured: 3 Month
Interleukin-1beta
IL-1 is a protein produced mainly by monocytes and macrophages as a polyclonal activator.
Measured: Baseline
Interleukin-1beta
IL-1 is a protein produced mainly by monocytes and macrophages as a polyclonal activator.
Measured: 1 Month
Interleukin-1beta
IL-1 is a protein produced mainly by monocytes and macrophages as a polyclonal activator.
Measured: 3 Month
Interleukin-10
IL-10 is an 18 kilodalton (KD) cytokine with a wide variety of (pleiotropic) effects.
Measured: Baseline
Interleukin-10
IL-10 is an 18 kilodalton (KD) cytokine with a wide variety of (pleiotropic) effects.
Measured: 1 Month
Interleukin-10
IL-10 is an 18 kilodalton (KD) cytokine with a wide variety of (pleiotropic) effects.
Measured: 3 Month
vascular endothelial growth factor (VEGF)
VEGF is a glycoprotein molecule that is a potential stimulator of angiogenesis.
Measured: Baseline
vascular endothelial growth factor (VEGF)
VEGF is a glycoprotein molecule that is a potential stimulator of angiogenesis.
Measured: 1 Month
vascular endothelial growth factor (VEGF)
VEGF is a glycoprotein molecule that is a potential stimulator of angiogenesis.
Measured: 3 Month
Radiographic bone fill
The effects of treatments on bone loss were evaluated by making some measurements on periapical radiography.
Measured: Baseline
Radiographic bone fill
The effects of treatments on bone loss were evaluated by making some measurements on periapical radiography.
Measured: 1 Month
Radiographic bone fill
The effects of treatments on bone loss were evaluated by making some measurements on periapical radiography.
Measured: 3 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2021
- Study start2 Oct 2017
- Primary completion16 Apr 2018
- Study completion15 Jun 2018
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
- Model description
- single-blind randomized controlled clinical study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir Katip Celebi University
- Sponsor type
- University, hospital or other
- Collaborators
- Turkısh Medicines And Medical Devices Agency
- Responsible party
- Principal investigator, Fadime KAYA DADAS, Izmir Katip Celebi University
- Investigators
- Serhat Köseoğlu, Study director, study manager
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04694222
- Sponsor's protocol ID
- 2017-TDU-DİŞF-0040
- Acronym
- LANAP LLLT
- Status last verified
- Jan 2021
- First submitted
- 30 Dec 2020
- Last updated
- 5 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Kaya Dadas F, Genc Kocaayan S, Saglam M, Dadas OF, Koseoglu S. Evaluating efficacy of laser-assisted new attachment procedure and adjunctive low-level laser therapy in treating periodontitis: A single-blind randomized controlled clinical study. Lasers Med Sci. 2025 Apr 22;40(1):208. doi: 10.1007/s10103-025-04457-0.
PubMed 40259146
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Efficacy of LANAP and Adjunctive LLLT Application in the Treatment of Periodontitis: A Randomized Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT04694222
- Acronym / sponsor ID
- LANAP LLLT / 2017-TDU-DİŞF-0040
- Conditions
- Periodontitis
- Keywords
- Laser Assisted New Attachment Procedure, Low Level Laser Therapy, periodontitis, non-surgical periodontal therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Izmir Katip Celebi UniversityUniversity, hospital or other
- Collaborators
- Turkısh Medicines And Medical Devices Agency
- Study start
- 2 Oct 2017 (actual)
- Primary completion
- 16 Apr 2018 (actual)
- Study completion
- 15 Jun 2018 (actual)
- First posted
- 5 Jan 2021 (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.
In this study, it is evaluated the effects of laser assisted new attachment procedure (LANAP) and low level laser therapy (LLLT) and on clinical, biochemical and radiographic parameters in addition to non-surgical periodontal treatment (NSPT).
Detailed description
The study was designed as a randomized-controlled, single-blind and parallel design consisting of 80 patients with chronic periodontitis. Study consists of 4 groups, with 20 patients in each group. Group 1 received only NSPT, Group 2 received NSPT+LANAP, Group 3 received NSPT+LLLT, and Group 4 received NSPT+LANAP+LLLT. Clinical measurements of patients and gingival crevicular fluid (GCF) were taken before treatment and after 1 and 3 months. In GCF, interleukin-1beta, interleukin-10 and vascular endothelial growth factor were analyzed. Standard periapical radiographs were taken for radiographic measurements.
In moderate (4-6 mm) and deep pockets (7 mm and above), it was found that all groups treated with laser significantly decrease pocket depth (PD) and clinic attachment level (CAL) compared to Group 1. Group 3 caused significantly less gingival recession than all other groups. There was no statistical difference between the groups in biochemical markers. Radiographic analysis revealed that only Group 2 achieved significant bone filling compared to Group 1.
Bot LANAP and LLLT application in the deep pockets provide an additional contribution to NSPT. It has been found that LLLT administration leads to decrease in PD by creating a minimum recession.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- single-blind randomized controlled clinical study
| Arm | Type | Receives |
|---|---|---|
| Control Group | Other | Device: Nd:YAG laserscaling and root planning (SRP) was applied. |
| LANAP Group | Active comparator | Device: Nd:YAG laserAfter scaling and polishing, three LANAP stages were performed : In the first stage, Nd:YAG laser was applied. In the second stage, full mouth SRP procedure was performed. In the third stage, Nd:YAG laser was applied again. |
| LLLT Group | Active comparator | Device: Nd:YAG laserafter SRP Low Level Laser Therapy was performed using Nd:YAG laser. |
| LANAP+LLLT Group | Active comparator | Device: Nd:YAG laserafter scaling both LANAP and LLLT were applied. |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- periodontitis of periodontal stage II, III, or IV with grades B
- with at least 12 teeth in the mouth and had ≥4 teeth but not all of them in the same quadrant
- with Probing depth of ≥5 mm, Clinical attachment level of ≥4 mm
- radiographic evidence of alveolar bone loss
Key exclusion criteria (4 listed)
- smoking
- pregnancy and lactation
- using antibiotics in the last 6 months and anti-inflammatory drugs in the last 3rd months,
- having the systemic disease and the use of the drug that will affect the periodontal condition, having restoration of the adjacent tooth to be collected gingival crevicular fluid
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 |
|---|---|---|
| Nd:YAG laserFor LANAP, the fiber optic tip of the Nd:YAG laser (1064 nm) (Fotona Fidelis AT, USA) was used. For LLLT R24 biostimulation handpiece tip (950-μm) Nd:YAG laser (1064 nm) was used. | Device | Control Group, LANAP Group, LANAP+LLLT Group, LLLT Group |
Primary outcome
Clinical attachment level gain
Time frame: Baseline
The clinical attachment level is determined by measuring the distance from the cemento-enamel junction to the gingival margin and adding the pocket depth to it.
Clinical attachment level gain
Time frame: 1 month
The clinical attachment level is determined by measuring the distance from the cemento-enamel junction to the gingival margin and adding the pocket depth to it.
Clinical attachment level gain
Time frame: 3 month
The clinical attachment level is determined by measuring the distance from the cemento-enamel junction to the gingival margin and adding the pocket depth to it.
24 secondary outcomes
Probing depth
Time frame: Baseline
Probing depth
Time frame: 1 Month
Probing depth
Time frame: 3 Month
Gingival index
Time frame: Baseline
Gingival index
Time frame: 1 Month
Gingival index
Time frame: 3 Month
Plaque index
Time frame: Baseline
Plaque index
Time frame: 1 Month
Plaque index
Time frame: 3 Month
Bleeding on probing
Time frame: Baseline
Bleeding on probing
Time frame: 1 Month
Bleeding on probing
Time frame: 3 Month
Interleukin-1beta
Time frame: Baseline
Interleukin-1beta
Time frame: 1 Month
Interleukin-1beta
Time frame: 3 Month
Interleukin-10
Time frame: Baseline
Interleukin-10
Time frame: 1 Month
Interleukin-10
Time frame: 3 Month
vascular endothelial growth factor (VEGF)
Time frame: Baseline
vascular endothelial growth factor (VEGF)
Time frame: 1 Month
vascular endothelial growth factor (VEGF)
Time frame: 3 Month
Radiographic bone fill
Time frame: Baseline
Radiographic bone fill
Time frame: 1 Month
Radiographic bone fill
Time frame: 3 Month
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 5 Jan 2021.
- Derived from this study: PubMed 40259146Kaya Dadas F, Genc Kocaayan S, Saglam M, Dadas OF, Koseoglu S. Evaluating efficacy of laser-assisted new attachment procedure and adjunctive low-level laser therapy in treating periodontitis: A single-blind randomized controlled clinical study. Lasers Med Sci. 2025 Apr 22;40(1):208. doi: 10.1007/s10103-025-04457-0.
- Individual participant dataSharing planned: No
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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.
Serhat Köseoğlu study director
study manager
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nd:YAG laser in people with Periodontitis, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
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 4 inclusion and 4 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 5 Jan 2021. 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 Turkey (Türkiye). 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?
Clinical attachment level gain (time frame: Baseline). 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?
On the ClinicalTrials.gov record for NCT04694222, 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 5 Jan 2021.