RecruitingNCT06866431

Effect Of Cavitation In Post-Extractive Socket Healing


Sponsor

International Piezosurgery Academy

Enrollment

84 participants

Start Date

Apr 1, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

In everyday clinical practice, the proper management of the post-extraction socket is crucial in order to enable an optimal healing of the wound and a close post-surgical monitoring is critical to prevent possible complications. After an injury, the cellular reaction starts early, presenting significant changes as soon as 12 to 24 hours later. Favourable wound healing begins with the timely formation, organization, stabilization, and attachment of the blood clot. The stability of the clot is influenced by various factors including the host response, local anatomical characteristics, presence of bacteria and severity of surgical trauma. Delayed healing can lead to increased complications, patient discomfort, and potential procedure failures. In the light of these considerations, the proven effectiveness of piezoelectric devices to facilitate healing mechanisms is known in literature. Inverse piezoelectric effect, as used in current devices, creates mechanical shock waves that oscillate linearly at sonic and ultrasonic frequencies (from 30 to 30.000 Hz). In addition, mechanical micro-movements with a frequency between approximately 24 and 30 kHz create a cavitation effect in the irrigation solution, limiting intraoperative bleeding, thereby increasing the visibility and safety of the procedure. The purpose of the present study is to evaluate if the application of cavitation effect of post-extractive socket is capable of reducing healing time and Numeric Pain Rating Scale (NPRS) values.


Eligibility

Min Age: 18 YearsMax Age: 100 Years

Inclusion Criteria4

  • Age between 18 and 100 years
  • Two single rooted hopeless teeth of the same arch to be extracted
  • ASA scale value equal or less than 3
  • Signed informed consent

Exclusion Criteria9

  • General contraindications for dental and/or surgical treatments
  • Inflammatory and autoimmune disease of the oral cavity
  • Uncontrolled diabetes (HbA1c > 7.5%)
  • History of malignancy requiring chemotherapy or radiotherapy within the past five years
  • Previous immunosuppressant bisphosphonate or high dose corticosteroid therapy
  • Heavy smokers (> 20 cigarettes /day)
  • Pregnancy or lactating women
  • No compliance
  • Extraction performed after raising a flap and/or with osteotomy

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Interventions

PROCEDUREPiezoclean

Following local anesthesia and periotomy, flapless extraction will be performed using forceps and elevators. After socket debridement with Lucas surgical curette, the extraction sockets will be randomly divided into test and control group.Test group sites will receive 90 seconds of ultrasonic cavitation treatment with 0.9% sodium chloride via a specific insert (Piezoclean, Esacrom, Imola, Italy) driven by a piezoelectric device with the following modalities: i) piezo settings: SURGERY 1 U 040 V 080 P 100; ii) no pressure should be applied to prevent the steel insert from coming into contact with the bone; iii) do not create a complete seal to avoid heating the liquid, which could cause potential discomfort or harm to the patient. An "X" suture will be then applied using non-resorbable synthetic monofilament.

PROCEDUREControl

Following local anesthesia and periotomy, flapless extraction will be performed using forceps and elevators. After socket debridement with Lucas surgical curette, the extraction sockets will be randomly divided into test and control group. In control group, a simple 0.9% sodium chloride irrigation (control group) will be performed. An "X" suture will be then applied using non-resorbable synthetic monofilament.


Locations(1)

University of Trieste

Trieste, TS, Italy

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NCT06866431