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

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: Recruiting
• Conditions: Periodontitis
• Intervention / Treatment: Procedure: SRP; Procedure: Nd: YAG Laser Assisted SRP

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: Interventional
• Enrollment (Estimated): 22
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jingyi Tan, Doctor; Phone Number: 15967121069; Email: tanjingyi@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • Recruiting
      • The Second Affiliated Hospital of Zhejiang University School of Medicine
      • Contact: Jingyi Tan, doctor; Phone Number: 15967121069; Email: tangjingyi@zju.edu.cn

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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.	Baseline，6 weeks，3months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	Baseline，6 weeks，3months

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Investigators: Principal Investigator: Jingyi Tan, Doctor, Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): September 4, 2024
• Primary Completion (Estimated): December 20, 2024
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: September 4, 2024
• First Submitted That Met QC Criteria: September 4, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): September 20, 2024
• Last Update Submitted That Met QC Criteria: September 18, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Periodontitis; Nd: YAG Laser
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis
• Other Study ID 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