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

Condition(s) studied

Investigational drug(s) / intervention(s)

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: 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 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 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."

Eligibility

Primary outcome measure(s)

• Pocket Probing Depth (PPD) — 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.

Trial sites (1)

More Second Affiliated Hospital, Zhejiang University, School of Medicine trials in China

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