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

NCT06587334 | Recruiting

• 1 other identifier: 2023-1104
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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

Conditions

Periodontitis

Keywords

Nd: YAG Laser; Periodontitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Gingival index，GI

  Baseline，6 weeks，3months

• Clinical attachment loss，CAL

  Baseline，6 weeks，3months

• Concentration of interleukin-6（IL-6）

  Baseline，6 weeks，3months

• Concentration of tumor necrosis factor-alpha（TNF-α）

  Baseline，6 weeks，3months

• Concentration of malondialdehyde（MDA）

  Baseline，6 weeks，3months

Study Arms (2)

Control Group

ACTIVE COMPARATOR

The control group will receive SRP alone

Procedure: SRP

Laser Group

EXPERIMENTAL

The laser group will receive SRP combined with Nd laser-assisted therapy

Procedure: Nd: YAG Laser Assisted SRP

Interventions

SRP PROCEDURE

SRP alone

Control Group

Nd: YAG Laser Assisted SRP PROCEDURE

the patients receive SRP combined with Nd: YAG laser

Laser Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 40876623 DERIVED

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Jingyi Tan, Doctor

  Second Affiliated Hospital, School of Medicine, Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jingyi Tan, Doctor

CONTACT

15967121069; tanjingyi@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 4, 2024
• First Posted: September 19, 2024
• Study Start: September 4, 2024
• Primary Completion: December 20, 2024
• Study Completion: December 30, 2024
• Last Updated: September 20, 2024

Record last verified: 2024-05

Locations

CN (1)