PeriodontitisNCT06587334
the Clinical Effect of Nd: YAG Laser Assisted Periodontal Initial Therapy in Patients With Moderate to Severe Periodontitis
A study testing SRP and Nd: YAG Laser Assisted SRP in people with Periodontitis, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
The goal of this clinical trial is to learn if Neodymium-Doped Yttrium Aluminum Garnet（Nd: YAG） Laser-assisted non-surgical periodontal treatment is effective in treating stage II/III periodontitis. It will also evaluate the safety and impact of the laser treatment. The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Periodontitis
- What is being tested?
- SRP and Nd: YAG Laser Assisted SRP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteChina
- Study dates
- 4 Sep 2024to 30 Dec 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 65 years, with no gender restrictions.
- Diagnosed with stage II or III periodontitis according to the 2018 Classification of Periodontal and Peri-Implant Diseases and Conditions.
- In each of the four quadrants of the oral cavity, at least one tooth must have at least one site with a probing depth ≥5 mm, clinical attachment loss ≥2 mm, and bleeding on probing.
- Participants must provide informed consent and sign the informed consent form.
Who cannot join
- Fewer than 20 remaining teeth (10 pairs of opposing teeth) or a significant discrepancy in the number of remaining teeth between the left and right sides of the mouth.
- Patients who have undergone periodontal treatment within the past six months or are currently undergoing orthodontic treatment, which may affect periodontal health.
- Patients with systemic diseases that could influence the outcomes of periodontal treatment.
- Patients with severe infections, malignancies, or other major diseases affecting overall health.
- Pregnant or breastfeeding women.
- Individuals with a history of smoking.
- Patients who are unable to comply with or complete periodontal treatment.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
Jingyi Tan, doctor, 15967121069, tangjingyi@zju.edu.cn
About this study
Official title: the Clinical Effect of Nd: YAG Laser Assisted Periodontal Initial Therapy in Patients With Moderate to Severe Periodontitis: a Split-mouth, Randomized, Controlled Clinical Trial
The goal of this clinical trial is to learn if Neodymium-Doped Yttrium Aluminum Garnet（Nd: YAG） Laser-assisted non-surgical periodontal treatment is effective in treating stage II/III periodontitis. It will also evaluate the safety and impact of the laser treatment. The main questions it aims to answer are:
- Does Nd: YAG Laser treatment reduce probing depth, gingival inflammation, and clinical attachment loss more effectively than standard Scaling and root planing(SRP) therapy alone?
- What changes in inflammatory markers and oxidative stress levels occur when patients receive laser-assisted therapy? Researchers will compare Nd: YAG Laser treatment to standard periodontal therapy alone to determine the effectiveness of the laser treatment.
Read more
Participants will:
- Receive Nd: YAG Laser assisted therapy on one side of their mouth and standard therapy on the other side.
- Visit the clinic at baseline, 6 weeks, and 3 months for follow-up assessments and tests.
- Provide samples and have measurements taken of periodontal health and biomarkers of inflammation and oxidative stress.
Read the detailed description
To investigate the clinical effect of Nd: YAG laser assisted non-surgical periodontal treatment on the patients with stage II / III periodontitis. This study included patients with stage II/III periodontitis who visited the Second Affiliated Hospital of Zhejiang University School of Medicine. Using a split-mouth design, the random number method was used to determine whether the left or right half of the subjects were in the laser group, and the remaining half were in the control group. All subjects underwent periodontal initial therapy, and the laser group received extra periodontal irradiation treatment using Nd: YAG laser. Before treatment, 6 weeks after treatment, and 3 months after treatment, the probing depth (PD), gingival index (GI), and clinical attachment loss (CAL) of all subjects were recorded. At the same time, the gingival crevicular fluid samples of thesubjects were collected using absorbent paper tips. The levels of Interleukin-6 (IL-6), Tumor necrosis factor-alpha (TNF-α), and Malondialdehyde (MDA) were measured using assay kits. Analyze and compare the changes in data before and after each group.
- Conditions
- Periodontitis
- Being tested
- SRP, Nd: YAG Laser Assisted SRP
- Keywords
- Nd: YAG Laser, Periodontitis
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SRPProcedure or surgery
SRP alone
Nd: YAG Laser Assisted SRPProcedure or surgery
the patients receive SRP combined with Nd: YAG laser
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | The control group will receive SRP alone Receives: Procedure: SRP |
| Laser Group | Experimental | The laser group will receive SRP combined with Nd laser-assisted therapy Receives: Procedure: Nd: YAG Laser Assisted SRP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probing depth，PD
Probing depth refers to the distance from the gingival margin to the base of the periodontal pocket. It is measured using a periodontal probe at multiple sites around each tooth. A reduction in probing depth is indicative of periodontal health improvement following treatment.
Measured: Baseline，6 weeks，3months
Secondary outcomes (5)
Gingival index，GI
The Gingival Index is a clinical measure used to assess the severity of gingivitis based on the presence of inflammation, bleeding on probing, and changes in gingival color. It is scored on a scale from 0 (healthy gingiva) to 3 (severe inflammation). Lower scores post-treatment suggest improved gingival health.
Measured: Baseline，6 weeks，3months
Clinical attachment loss，CAL
Clinical attachment loss is the measurement of the distance from the cemento-enamel junction (CEJ) to the base of the periodontal pocket. It reflects the extent of periodontal tissue destruction. A decrease in CAL indicates successful periodontal treatment and improved attachment of the tooth to the surrounding bone and tissue.
Measured: Baseline，6 weeks，3months
Concentration of interleukin-6（IL-6）
Interleukin-6 is a pro-inflammatory cytokine measured in gingival crevicular fluid. It is used as a biomarker to assess the inflammatory response in periodontal tissues. Higher levels are associated with active inflammation, and a reduction post-treatment may indicate a successful anti-inflammatory effect of the therapy.
Measured: Baseline，6 weeks，3months
Concentration of tumor necrosis factor-alpha（TNF-α）
Tumor necrosis factor-alpha is another key pro-inflammatory cytokine involved in the pathogenesis of periodontal disease. It is typically measured in gingival crevicular fluid. Similar to IL-6, elevated levels suggest active inflammation, while decreased levels post-treatment indicate a reduction in inflammatory activity.
Measured: Baseline，6 weeks，3months
Concentration of malondialdehyde（MDA）
Malondialdehyde is a biomarker of oxidative stress, typically measured in gingival crevicular fluid. It reflects the extent of lipid peroxidation and cellular damage. Lower MDA levels after treatment suggest reduced oxidative stress and potential improvement in periodontal tissue health.
Measured: Baseline，6 weeks，3months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start4 Sep 2024
- Primary completion20 Dec 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
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.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- 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
- Crossover
- Model description
- The study adopts a split-mouth design with each subject serving as their own control. A random number method is used to determine whether the left or right half of the mouth will be assigned to the laser group, with the remaining half assigned to the control group. The laser group will receive SRP combined with Nd laser-assisted therapy, while the control group will receive SRP alone.
- Masking
- None (open label)
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jingyi Tan, Doctor, Principal investigator, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06587334
- Sponsor's protocol ID
- 2023-1104
- Status last verified
- May 2024
- First submitted
- 4 Sep 2024
- Last updated
- 20 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bian Z, Zhang H, Chen Y, Yang Y, Lin Q, Chen X, Chen L, Sun W, Tan J. Clinical effect of Nd:YAG laser-assisted non-surgical periodontal treatment on stage II/III periodontitis. J Dent. 2025 Nov;162:106056. doi: 10.1016/j.jdent.2025.106056. Epub 2025 Aug 26.
PubMed 40876623
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Clinical Effect of Nd: YAG Laser Assisted Periodontal Initial Therapy in Patients With Moderate to Severe Periodontitis: a Split-mouth, Randomized, Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06587334
- Acronym / sponsor ID
- 2023-1104
- Conditions
- Periodontitis
- Keywords
- Nd: YAG Laser, Periodontitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 4 Sep 2024 (actual)
- Primary completion
- 20 Dec 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 19 Sep 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 goal of this clinical trial is to learn if Neodymium-Doped Yttrium Aluminum Garnet（Nd: YAG） Laser-assisted non-surgical periodontal treatment is effective in treating stage II/III periodontitis. It will also evaluate the safety and impact of the laser treatment. The main questions it aims to answer are:
- Does Nd: YAG Laser treatment reduce probing depth, gingival inflammation, and clinical attachment loss more effectively than standard Scaling and root planing(SRP) therapy alone?
- What changes in inflammatory markers and oxidative stress levels occur when patients receive laser-assisted therapy? Researchers will compare Nd: YAG Laser treatment to standard periodontal therapy alone to determine the effectiveness of the laser treatment.
Participants will:
- Receive Nd: YAG Laser assisted therapy on one side of their mouth and standard therapy on the other side.
- Visit the clinic at baseline, 6 weeks, and 3 months for follow-up assessments and tests.
- Provide samples and have measurements taken of periodontal health and biomarkers of inflammation and oxidative stress.
Detailed description
To investigate the clinical effect of Nd: YAG laser assisted non-surgical periodontal treatment on the patients with stage II / III periodontitis. This study included patients with stage II/III periodontitis who visited the Second Affiliated Hospital of Zhejiang University School of Medicine. Using a split-mouth design, the random number method was used to determine whether the left or right half of the subjects were in the laser group, and the remaining half were in the control group. All subjects underwent periodontal initial therapy, and the laser group received extra periodontal irradiation treatment using Nd: YAG laser. Before treatment, 6 weeks after treatment, and 3 months after treatment, the probing depth (PD), gingival index (GI), and clinical attachment loss (CAL) of all subjects were recorded. At the same time, the gingival crevicular fluid samples of thesubjects were collected using absorbent paper tips. The levels of Interleukin-6 (IL-6), Tumor necrosis factor-alpha (TNF-α), and Malondialdehyde (MDA) were measured using assay kits. Analyze and compare the changes in data before and after each group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study adopts a split-mouth design with each subject serving as their own control. A random number method is used to determine whether the left or right half of the mouth will be assigned to the laser group, with the remaining half assigned to the control group. The laser group will receive SRP combined with Nd laser-assisted therapy, while the control group will receive SRP alone.
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Procedure: SRPThe control group will receive SRP alone |
| Laser Group | Experimental | Procedure: Nd: YAG Laser Assisted SRPThe laser group will receive SRP combined with Nd laser-assisted therapy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age between 18 and 65 years, with no gender restrictions.
- Diagnosed with stage II or III periodontitis according to the 2018 Classification of Periodontal and Peri-Implant Diseases and Conditions.
- In each of the four quadrants of the oral cavity, at least one tooth must have at least one site with a probing depth ≥5 mm, clinical attachment loss ≥2 mm, and bleeding on probing.
- Participants must provide informed consent and sign the informed consent form.
Key exclusion criteria (7 listed)
- Fewer than 20 remaining teeth (10 pairs of opposing teeth) or a significant discrepancy in the number of remaining teeth between the left and right sides of the mouth.
- Patients who have undergone periodontal treatment within the past six months or are currently undergoing orthodontic treatment, which may affect periodontal health.
- Patients with systemic diseases that could influence the outcomes of periodontal treatment.
- Patients with severe infections, malignancies, or other major diseases affecting overall health.
- Pregnant or breastfeeding women.
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 |
|---|---|---|
| SRPSRP alone | Procedure or surgery | Control Group |
| Nd: YAG Laser Assisted SRPthe patients receive SRP combined with Nd: YAG laser | Procedure or surgery | Laser Group |
Primary outcome
Probing depth，PD
Time frame: Baseline，6 weeks，3months
Probing depth refers to the distance from the gingival margin to the base of the periodontal pocket. It is measured using a periodontal probe at multiple sites around each tooth. A reduction in probing depth is indicative of periodontal health improvement following treatment.
5 secondary outcomes
Gingival index，GI
Time frame: Baseline，6 weeks，3months
Clinical attachment loss，CAL
Time frame: Baseline，6 weeks，3months
Concentration of interleukin-6（IL-6）
Time frame: Baseline，6 weeks，3months
Concentration of tumor necrosis factor-alpha（TNF-α）
Time frame: Baseline，6 weeks，3months
Concentration of malondialdehyde（MDA）
Time frame: Baseline，6 weeks，3months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2024.
- Derived from this study: PubMed 40876623Bian Z, Zhang H, Chen Y, Yang Y, Lin Q, Chen X, Chen L, Sun W, Tan J. Clinical effect of Nd:YAG laser-assisted non-surgical periodontal treatment on stage II/III periodontitis. J Dent. 2025 Nov;162:106056. doi: 10.1016/j.jdent.2025.106056. Epub 2025 Aug 26.
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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.
Jingyi Tan, Doctor principal investigator
Second Affiliated Hospital, Zhejiang University, School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SRP and Nd: YAG Laser Assisted SRP in people with Periodontitis, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
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 7 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 20 Sep 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 China. 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 Jingyi Tan, Doctor (15967121069, tanjingyi@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Probing depth，PD (time frame: Baseline，6 weeks，3months). 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 NCT06587334, 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 20 Sep 2024.