Ignite Creation Date:
2025-12-25 @ 2:23 AM
Ignite Modification Date:
2026-01-03 @ 3:15 AM
Study NCT ID:
NCT06587334
Status:
RECRUITING
Last Update Posted:
2024-09-20
First Post:
2024-09-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
the Clinical Effect of Nd: YAG Laser Assisted Periodontal Initial Therapy in Patients With Moderate to Severe Periodontitis
Sponsor:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Organization:
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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. 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.
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.
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: