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

Обзор

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."

Подробное описание

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.

Вмешательства

• Процедура 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 regi
• Процедура 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 regi

Первичные конечные точки

• Pocket Probing Depth (PPD) [Срок оценки: Pre-treatment (baseline), Follow up evaluation at 1 week, 6 weeks, 3 months and 6 months after treatment]

Вторичные конечные точки (6)

• clinical attachment level (CAL) [Срок оценки: Pre-treatment (baseline), Follow up evaluation at 1 week, 6 weeks, 3 months and 6 months after treatment]
• plaque index (PI) [Срок оценки: Pre-treatment (baseline), Follow-up evaluations were conducted at 6 weeks, 3 months and 6 months after the treatment.]
• bleeding index (BI) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: Pre-treatment (baseline), Follow up evaluation at 1 week, 6 weeks, 3 months and 6 months after treatment]
• Tooth mobility [Срок оценки: Pre-treatment (baseline), Follow up evaluation at 1 week, 6 weeks, 3 months and 6 months after treatment]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• The Second Affiliated Hospital of Zhejiang University School of Medicine — Ханчжоу

Публикации

• 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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 periodo PMID 29926499

Идентификаторы

NCT: NCT07487285 · 2026-0028

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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