A Non-inferiority Study of Laser Combined With Ultrasonic Debridement Therapy (LCUDT) Versus Manual Combined With Ultrasonic Debridement Therapy (MCUDT) in the Treatment of Periodontitis

April 7, 2026 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University
The rate of periodontal health among adults and the elderly in China is less than 10%, with the prevalence of severe periodontitis reaching 30.6% in those aged 35 and above. While conventional periodontal treatment (ultrasonic combined with manual subgingival scaling) is effective, it has significant drawbacks: it is technically demanding, time-consuming, and often causes patients considerable pain and discomfort. This can lead to poor treatment compliance, postoperative tissue damage, bleeding, and root sensitivity.Lasers, such as the Nd:YAG laser, offer advantages like antibacterial effects and minimally invasive debridement. Combining ultrasonic with laser therapy may improve patient comfort, but there is currently insufficient evidence to prove that its clinical efficacy is non-inferior to traditional manual scaling.This study aims to compare the clinical efficacy, patient acceptance, and postoperative recovery between "ultrasonic combined with laser debridement" and "ultrasonic combined with manual mechanical debridement."

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet 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

The periodontal health rate in the adult and elderly groups in China is less than 10%, with a prevalence of severe periodontitis as high as 30.6% among adults aged 35 and above. The primary treatment goal of periodontitis is to control infection by removing dental plaque and calculus, preventing disease progression. Therefore, periodontal debridement is the most fundamental treatment required for every periodontitis patient. Although ultrasonic combined with manual subgingival scaling demonstrates good clinical efficacy in periodontitis treatment, it also has some significant drawbacks. First, the use of manual instruments requires higher technical skills and is time-consuming, especially when dealing with complex root surfaces. Second, the manual scaling process is relatively uncomfortable, and severe pain may prompt some patients to require analgesics or even refuse treatment, particularly in cases of moderate to severe periodontitis. Factors such as past dental anxiety can amplify this pain response, affecting treatment compliance. Additionally, manual scaling may cause damage to periodontal tissues in the treatment area, especially when operating in the subgingival region, where significant mechanical trauma can lead to postoperative discomfort, pain, and root surface sensitivity. This trauma not only affects the patient's treatment experience but may also reduce the regenerative capacity of gingival tissues after treatment. Moreover, postoperative bleeding and root surface roughness following manual scaling increase the risk of infection and complications. Conventional periodontal basic treatment typically involves ultrasonic combined with manual mechanical debridement, but due to the aforementioned issues, many patients have limited acceptance of manual subgingival scaling. This fear or resistance affects treatment compliance, ultimately impacting the prognosis of periodontitis patients. The technical difficulty of manual subgingival scaling also limits the promotion and application of this periodontal debridement technique. Therefore, there is an urgent need for an alternative technology that can effectively treat periodontitis while improving patient comfort and being easily mastered by clinicians. In recent years, lasers have gained widespread attention due to their localized antibacterial and hemostatic effects, as well as their ability to reduce inflammatory reactions. Nd:YAG lasers, a type of near-infrared laser, excel in sterilization, hemostasis, and tissue ablation, and have become an auxiliary treatment for periodontal disease. The minimally invasive debridement technique combining ultrasonic and laser has shown promising potential in treating periodontitis, particularly in enhancing patient comfort and reducing postoperative discomfort. However, there is still insufficient evidence to prove its non-inferiority in clinical efficacy compared to traditional ultrasonic combined with manual scaling. This study aims to compare the clinical efficacy, patient acceptance, and postoperative recovery between ultrasonic combined with laser debridement and ultrasonic combined with manual mechanical debridement through a muti-center randomized controlled trial, thereby providing a more scientific basis for periodontal disease treatment.This study was conducted in multiple centers using a stratified design, covering three provincial-level tertiary hospitals and three primary hospitals. The study adopts a split design (self controlled left and right sides) and plans to include at least 174 patients.

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.
174

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 Contact Backup

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310000
        • The Second Affiliated Hospital of Zhejiang University School of Medicine

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 ≥ 18 years old
  • Diagnosed with stage III-IV periodontitis, with at least 4 affected teeth on each side (left and right) having probing depth ≥ 5 mm
  • No periodontal basic treatment (e.g., scaling, root planing, flap surgery) performed within the past 6 months
  • Able to understand the study procedures, provide informed consent, and comply with protocol requirements
  • At least 10 remaining teeth on either side of one jaw (maxilla or mandible)

Exclusion Criteria:

  • Unstable or uncontrolled systemic diseases, including but not limited to progressive liver disease, active infectious disease, severe trauma, renal failure, rheumatoid arthritis, hematological disease, mental disorder, or diabetes mellitus
  • Presence of an implanted pacemaker
  • Pregnancy or lactation
  • Malignant tumors, or undergoing radiotherapy, chemotherapy, targeted therapy, or bisphosphonate treatment
  • Undergoing orthodontic treatment or those who have received orthodontic treatment within the past six months
  • Smokers

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: Parallel Assignment
  • Masking: Double

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.
Experimental: Laser Combined with Ultrasonic Debridement Therapy
Procedure: Experimental: Laser Combined with Ultrasonic Debridement Therapy
According to the International Federation of Dentistry (FDI) system, the patient's mouth is divided into two regions - left and right. The treatment is carried out in two stages: the first stage involves randomly applying either the minimally invasive periodontal debridement technique using ultrasound and laser or the traditional debridement technique using ultrasound and manual methods to the left/right regions of the patient's mouth; the second stage uses another method to treat the other region. Depending on the severity of periodontitis, the treatment can be completed in one session or in two sessions for the left and right sides.
Active Comparator: Manual Combined with Ultrasonic Debridement Therapy
Procedure: Active Comparator: Manual Combined with Ultrasonic Debridement Therapy
According to the International Federation of Dentistry (FDI) system, the patient's mouth is divided into two regions - left and right. The treatment is carried out in two stages: the first stage involves randomly applying either the minimally invasive periodontal debridement technique using ultrasound and laser or the traditional debridement technique using ultrasound and manual methods to the left/right regions of the patient's mouth; the second stage uses another method to treat the other region. Depending on the severity of periodontitis, the treatment can be completed in one session or in two sessions for the left and right sides.

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
Pocket Probing Depth (PPD)
Time Frame: Pre-treatment (baseline), Follow up evaluation at 1 week, 6 weeks, 3 months and 6 months after treatment
PPD is measured from the gingival margin to the base of the pocket using a periodontal probe. Measurements will be taken at six sites per tooth (mesiobuccal, mid-buccal, distobuccal, mesiolingual, mid-lingual, distolingual). The outcome will be reported as the improvement amount (ΔPPD) at the sites with probing depth (PPD) ≥ 5mm.
Pre-treatment (baseline), Follow up evaluation at 1 week, 6 weeks, 3 months and 6 months after treatment

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
clinical attachment level (CAL)
Time Frame: Pre-treatment (baseline), Follow up evaluation at 1 week, 6 weeks, 3 months and 6 months after treatment
CAL is the distance from the Cemento-Enamel Junction (CEJ) to the base of the pocket, measured with a periodontal probe. It indicates the historical loss of periodontal support. Measurements at six sites per tooth. The outcome will be reported as the mean CAL in millimeters per patient for all measured sites, and the improvement amount (ΔCAL) at the sites with probing depth (PPD) ≥ 5mm.
Pre-treatment (baseline), Follow up evaluation at 1 week, 6 weeks, 3 months and 6 months after treatment
plaque index (PI)
Time Frame: Pre-treatment (baseline), Follow-up evaluations were conducted at 6 weeks, 3 months and 6 months after the treatment.
The PI assesses the thickness of plaque at the gingival margin. Four sites per tooth (mesial, distal, buccal, lingual) are scored from 0 (no plaque) to 3 (abundance of plaque). A lower score indicates better oral hygiene. The outcome will be reported as the mean PI score per patient across all examined sites.
Pre-treatment (baseline), Follow-up evaluations were conducted at 6 weeks, 3 months and 6 months after the treatment.
bleeding index (BI)
Time Frame: Pre-treatment (baseline), Follow-up evaluations were conducted at 6 weeks, 3 months and 6 months after the treatment.
The BI assesses gingival inflammation by recording bleeding upon gentle probing. Each tooth is probed at four sites (mesial, distal, buccal, lingual) and scored as 0 (no bleeding within 30 seconds) or 1 (bleeding present). A lower score indicates healthier gingiva. The outcome will be reported as the mean BI score per patient (percentage of bleeding sites).
Pre-treatment (baseline), Follow-up evaluations were conducted at 6 weeks, 3 months and 6 months after the treatment.
Root surface hypersensitivity assessed by a Visual Analogue Scale (VAS)
Time Frame: Pre-treatment (baseline), Follow-up evaluations were conducted 1 week, 6 weeks, 3 months and 6 months after the treatment.
Participants rate their level of tooth sensitivity to cold air/water on a 100-mm horizontal VAS, where 0 mm = "No pain" and 100 mm = "Unbearable pain". A lower score indicates less sensitivity. The outcome will be reported as the mean VAS score (mm) per patient.
Pre-treatment (baseline), Follow-up evaluations were conducted 1 week, 6 weeks, 3 months and 6 months after the treatment.
Microbial composition of subgingival plaque (relative abundance of key periodontal pathogens)
Time Frame: Pre-treatment (baseline), Follow up evaluation at 1 week, 6 weeks, 3 months and 6 months after treatment
Subgingival plaque samples will be collected from pre-selected deep pockets. Microbial composition (e.g., relative abundance of Porphyromonas gingivalis, Treponema denticola, Tannerella forsythia) will be analyzed via 16S rRNA gene sequencing or specific PCR. The outcome will be reported as the change in relative abundance (%) of target pathogens from baseline.
Pre-treatment (baseline), Follow up evaluation at 1 week, 6 weeks, 3 months and 6 months after treatment
Tooth mobility
Time Frame: Pre-treatment (baseline), Follow up evaluation at 1 week, 6 weeks, 3 months and 6 months after treatment
I degree; mesiodistal direction mobility is recorded as II degree; vertical mobility is recorded as III degree.
Pre-treatment (baseline), Follow up evaluation at 1 week, 6 weeks, 3 months and 6 months after treatment

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Estimated)

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.
May 1, 2026

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 31, 2027

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 31, 2027

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).
March 17, 2026

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.
March 17, 2026

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.
March 23, 2026

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.
April 13, 2026

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.
April 7, 2026

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.
February 1, 2026

More Information

Terms related to this study

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.
  • 2026-0028

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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