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PeriodontitisNCT07487285

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

A study testing Experimental: Laser Combined with Ultrasonic Debridement Therapy and Active Comparator: Manual Combined with Ultrasonic Debridement Therapy in people with Periodontitis and Periodontal Debridement, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Periodontitis, Periodontal Debridement
What is being tested?
Experimental: Laser Combined with Ultrasonic Debridement Therapy and Active Comparator: Manual Combined with Ultrasonic Debridement Therapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
174 participants
Where
1 siteChina
Study dates
1 May 2026to 31 Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site
  • The Second Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310000

Other trials in China

About this study

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."

Read the 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.

Being tested
Experimental: Laser Combined with Ultrasonic Debridement Therapy, Active Comparator: Manual Combined with Ultrasonic Debridement Therapy
Medical subject headings
Periodontitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Experimental: Laser Combined with Ultrasonic Debridement TherapyProcedure or surgery

    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 TherapyProcedure or surgery

    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.

Study groups in NCT07487285
Study groupRoleWhat they receive
Laser Combined with Ultrasonic Debridement TherapyExperimentalNot described
Receives: Procedure: Experimental: Laser Combined with Ultrasonic Debridement Therapy
Manual Combined with Ultrasonic Debridement TherapyActive comparatorNot described
Receives: Procedure: Active Comparator: Manual Combined with Ultrasonic Debridement Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pocket Probing Depth (PPD)

    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.

    Measured: Pre-treatment (baseline), Follow up evaluation at 1 week, 6 weeks, 3 months and 6 months after treatment

Secondary outcomes (6)
  1. clinical attachment level (CAL)

    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.

    Measured: Pre-treatment (baseline), Follow up evaluation at 1 week, 6 weeks, 3 months and 6 months after treatment

  2. plaque index (PI)

    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.

    Measured: Pre-treatment (baseline), Follow-up evaluations were conducted at 6 weeks, 3 months and 6 months after the treatment.

  3. bleeding index (BI)

    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).

    Measured: Pre-treatment (baseline), Follow-up evaluations were conducted at 6 weeks, 3 months and 6 months after the treatment.

  4. Root surface hypersensitivity assessed by a Visual Analogue Scale (VAS)

    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.

    Measured: Pre-treatment (baseline), Follow-up evaluations were conducted 1 week, 6 weeks, 3 months and 6 months after the treatment.

  5. Microbial composition of subgingival plaque (relative abundance of key periodontal pathogens)

    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.

    Measured: Pre-treatment (baseline), Follow up evaluation at 1 week, 6 weeks, 3 months and 6 months after treatment

  6. Tooth mobility

    I degree; mesiodistal direction mobility is recorded as II degree; vertical mobility is recorded as III degree.

    Measured: Pre-treatment (baseline), Follow up evaluation at 1 week, 6 weeks, 3 months and 6 months after treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Mar 2026
  2. Study start1 May 2026 (estimated)
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Care provider, Outcomes assessor
Enrolment
174 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07487285
Sponsor's protocol ID
2026-0028
Status last verified
Feb 2026
First submitted
17 Mar 2026
Last updated
13 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Alkan II, Akkaya HU, Saglam M. The effectiveness of scaling and root planing with combined application of air polishing and Nd:YAG laser in periodontal pockets of stage III grade C periodontitis patients: a single-blinded randomized clinical trial. Clin Oral Investig. 2022 Aug;26(8):5459-5469. doi: 10.1007/s00784-022-04513-x. Epub 2022 May 3.

    PubMed 35505199
  • Zengin Celik T, Saglam E, Ercan C, Akbas F, Nazaroglu K, Tunali M. Clinical and Microbiological Effects of the Use of Erbium: Yttrium-Aluminum-Garnet Laser on Chronic Periodontitis in Addition to Nonsurgical Periodontal Treatment: A Randomized Clinical Trial-6 Months Follow-Up. Photobiomodul Photomed Laser Surg. 2019 Mar;37(3):182-190. doi: 10.1089/photob.2018.4510. Epub 2019 Feb 21.

    PubMed 31050949
  • Suvan J, Leira Y, Moreno Sancho FM, Graziani F, Derks J, Tomasi C. Subgingival instrumentation for treatment of periodontitis. A systematic review. J Clin Periodontol. 2020 Jul;47 Suppl 22:155-175. doi: 10.1111/jcpe.13245.

    PubMed 31889320
  • Zhang X, Hu Z, Zhu X, Li W, Chen J. Treating periodontitis-a systematic review and meta-analysis comparing ultrasonic and manual subgingival scaling at different probing pocket depths. BMC Oral Health. 2020 Jun 25;20(1):176. doi: 10.1186/s12903-020-01117-3.

    PubMed 32586315
  • Duran-Pinedo AE, Solbiati J, Teles F, Frias-Lopez J. Subgingival host-microbiome metatranscriptomic changes following scaling and root planing in grade II/III periodontitis. J Clin Periodontol. 2023 Mar;50(3):316-330. doi: 10.1111/jcpe.13737. Epub 2022 Nov 26.

    PubMed 36281629
  • Cui Y, Tian G, Li R, Shi Y, Zhou T, Yan Y. Epidemiological and sociodemographic transitions of severe periodontitis incidence, prevalence, and disability-adjusted life years for 21 world regions and globally from 1990 to 2019: An age-period-cohort analysis. J Periodontol. 2023 Feb;94(2):193-203. doi: 10.1002/JPER.22-0241. Epub 2023 Jan 10.

    PubMed 35942553
  • Kapila YL. Oral health's inextricable connection to systemic health: Special populations bring to bear multimodal relationships and factors connecting periodontal disease to systemic diseases and conditions. Periodontol 2000. 2021 Oct;87(1):11-16. doi: 10.1111/prd.12398.

    PubMed 34463994
  • Chapple ILC, Mealey BL, Van Dyke TE, Bartold PM, Dommisch H, Eickholz P, Geisinger ML, Genco RJ, Glogauer M, Goldstein M, Griffin TJ, Holmstrup P, Johnson GK, Kapila Y, Lang NP, Meyle J, Murakami S, Plemons J, Romito GA, Shapira L, Tatakis DN, Teughels W, Trombelli L, Walter C, Wimmer G, Xenoudi P, Yoshie H. Periodontal health and gingival diseases and conditions on an intact and a reduced periodontium: Consensus report of workgroup 1 of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions. J Clin Periodontol. 2018 Jun;45 Suppl 20:S68-S77. doi: 10.1111/jcpe.12940.

    PubMed 29926499

Questions about this trial

What is this clinical trial studying?

A study testing Experimental: Laser Combined with Ultrasonic Debridement Therapy and Active Comparator: Manual Combined with Ultrasonic Debridement Therapy in people with Periodontitis and Periodontal Debridement, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Lihong Lei (00-86-571-86726890, kqllh@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pocket Probing Depth (PPD) (time frame: Pre-treatment (baseline), Follow up evaluation at 1 week, 6 weeks, 3 months and 6 months after treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07487285, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.

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