the Clinical Effect of Nd: YAG Laser Assisted Periodontal Initial Therapy in Patients With Moderate to Severe Periodontitis

September 18, 2024 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University

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:

  1. 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?
  2. 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:

  1. Receive Nd: YAG Laser assisted therapy on one side of their mouth and standard therapy on the other side.
  2. Visit the clinic at baseline, 6 weeks, and 3 months for follow-up assessments and tests.
  3. Provide samples and have measurements taken of periodontal health and biomarkers of inflammation and oxidative stress.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
22

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310009
        • Recruiting
        • The Second Affiliated hospital of Zhejiang University school of medicine
        • Contact:

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

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: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Control Group
The control group will receive SRP alone
Procedure: SRP
SRP alone
Experimental: Laser Group
The laser group will receive SRP combined with Nd laser-assisted therapy
Procedure: Nd: YAG Laser Assisted SRP
the patients receive SRP combined with Nd: YAG laser

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline，6 weeks，3months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Gingival index，GI
Time Frame: Baseline，6 weeks，3months
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.
Baseline，6 weeks，3months
Clinical attachment loss，CAL
Time Frame: Baseline，6 weeks，3months
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.
Baseline，6 weeks，3months
Concentration of interleukin-6（IL-6）
Time Frame: Baseline，6 weeks，3months
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.
Baseline，6 weeks，3months
Concentration of tumor necrosis factor-alpha（TNF-α）
Time Frame: Baseline，6 weeks，3months
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.
Baseline，6 weeks，3months
Concentration of malondialdehyde（MDA）
Time Frame: Baseline，6 weeks，3months
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.
Baseline，6 weeks，3months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jingyi Tan, Doctor, Second Affiliated Hospital, School of Medicine, Zhejiang University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 4, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 20, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 4, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 4, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 19, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 20, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 18, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2023-1104

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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