Nd:YAG Laser Effects on Subgingival Microbiota in Stage III-IV Periodontitis

NCT07061756 | Active Not Recruiting

• 1 other identifier: [2024]493-1
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled trial (RCT) aims to evaluate the clinical efficacy of Nd:YAG laser adjunctive therapy and its impact on the subgingival microbiome in patients with stage III-IV periodontitis. The study addresses two key questions: (1) Whether Nd:YAG laser combined with scaling and root planing (SRP) yields significantly greater improvements in periodontal parameters compared to SRP alone; and (2) How subgingival microbial dynamics correlate with therapeutic outcomes. Participants were randomized into two groups: the SRP group (mechanical debridement only) and the Nd group (mechanical debridement with Nd:YAG laser therapy). Clinical parameters-including probing depth (PD), clinical attachment level (CAL), and gingival index (GI)-were assessed at baseline and 3 months post-treatment. Subgingival plaque samples were analyzed via 16S rDNA sequencing to characterize microbial community shifts.

Conditions

Periodontitis

Outcome Measures

Primary Outcomes (2)

• Alpha diversity of subgingival microbiota

  The higher the alpha diversity, the greater the species richness and evenness of the microbial community.

  From enrollment to the end of treatment at 3 months

• Probing Depth

  Probing depth (PD) measures the distance from the gingival margin to the base of the periodontal pocket, clinically assessing periodontal attachment loss and tissue destruction.

  From enrollment to the end of treatment at 3 months

Secondary Outcomes (7)

• Beta diversity of subgingival microbiota

  From enrollment to the end of treatment at 3 months

• Composition of subgingival microbiota

  From enrollment to the end of treatment at 3 months

• Microbial phenotypes of subgingival microbiota

  From enrollment to the end of treatment at 3 months

• Clinical Attachment Level (CAL)

  From enrollment to the end of treatment at 3 months

• Gingival Index (GI)

  From enrollment to the end of treatment at 3 months

Study Arms (2)

Nd group

EXPERIMENTAL

The Nd group received comprehensive periodontal therapy combining scaling and root planing (SRP) with adjunctive Nd:YAG laser treatment.

Procedure: ND

SRP group

ACTIVE COMPARATOR

The SRP group received standard periodontal therapy consisting of scaling and root planing (SRP) alone, serving as the active control for comparison against laser-assisted treatment.

Procedure: SRP

Interventions

SRP PROCEDURE

Full-mouth scaling and root planing (SRP) was performed using an ultrasonic scaler (EMS AIR-FLOW MASTER PIEZON®) supplemented by Gracey curettes for subgingival instrumentation. All procedures were conducted under local anesthesia by a calibrated periodontist, with each quadrant treated for a minimum of 30 minutes. Patients received standardized oral hygiene instructions and were scheduled for a 3-month postoperative follow-up.

SRP group

ND PROCEDURE

In addition to the identical SRP protocol described above, adjunctive Nd:YAG laser therapy (Wiser Waterlase MD, Vista Dental) was applied immediately post-SRP. Laser parameters were set at 150 mJ/pulse, 20 Hz frequency with water (level 1) and air (level 3) coolant. The fiber optic tip (300 μm diameter) was moved in a continuous "Zig-zag" pattern along the root surface and pocket epithelium, maintaining 2-second irradiation per site at a 30° angle to the tooth axis. Standardized oral hygiene instructions and 3-month follow-up were similarly provided.

Nd group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18-80 years
• Minimum of 14 remaining natural teeth
• Diagnosis of Stage III-IV periodontitis according to the 2018 World Workshop classification system
• No periodontal treatment within the past 6 months
• Willing to provide informed consent and participate in the study protocol

You may not qualify if:

• Presence of systemic conditions that may affect periodontal treatment outcomes (e.g., uncontrolled hypertension \[\>140/90 mmHg\], diabetes mellitus \[HbA1c \>7%\])
• Use of antibiotics or medications known to induce gingival enlargement (e.g., calcium channel blockers, phenytoin) within the past 3 months
• Coagulation disorders or hematologic diseases
• Active systemic infections
• Pregnancy or lactation
• Acute periodontal lesions
• Inability to comply with study protocols

Sponsors & Collaborators

• Rui He: lead

Study Sites (1)

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510000, China

Location

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Resident Physician

Study Record Dates

• First Submitted: June 19, 2025
• First Posted: July 11, 2025
• Study Start: August 28, 2024
• Primary Completion: March 20, 2025
• Study Completion: July 24, 2025
• Last Updated: July 11, 2025

Record last verified: 2025-06

Locations

CN (1)