Effect Of Cavitation In Post-Extractive Socket Healing

NCT06866431 | Recruiting

• 1 other identifier: PIEZOCLEAN
• Study Type: observational
• Target: 84
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cavitation; Healing of Extraction Socket

Outcome Measures

Primary Outcomes (4)

• Maturation and quality of tissues in post extractive socket

  The maturation and quality of tissues will be evaluated using a modified version of the Healing Index (HI) that involves 3 scoring levels for each of the 4 parameters considered: * tissue color (1 = 100% of gingiva pink; 2 ≤ 50% of gingiva red, hyperemic, movable; 3 ≥ 50% of gingiva red, hyperemic, movable); * color and consistency of the healing tissue (1 = close grained, pink; 2 = soft, red; 3 = fragile, greenish or grayish); * suppuration (1 = absent; 2 = absent but pronounced amount of plaque around socket walls; 3 = pronounced); * bleeding (1 = absent; 2 = induced by palpation; 3 = spontaneous). The total score ranged from 4 (excellent healing) to 12 (severely impaired healing).

  3 days after tooth extraction

• Maturation and quality of tissues in post extractive socket

  The maturation and quality of tissues will be evaluated using a modified version of the Healing Index (HI) that involves 3 scoring levels for each of the 4 parameters considered: * tissue color (1 = 100% of gingiva pink; 2 ≤ 50% of gingiva red, hyperemic, movable; 3 ≥ 50% of gingiva red, hyperemic, movable); * color and consistency of the healing tissue (1 = close grained, pink; 2 = soft, red; 3 = fragile, greenish or grayish); * suppuration (1 = absent; 2 = absent but pronounced amount of plaque around socket walls; 3 = pronounced); * bleeding (1 = absent; 2 = induced by palpation; 3 = spontaneous). The total score ranged from 4 (excellent healing) to 12 (severely impaired healing).

  7 days after tooth extraction

• Maturation and quality of tissues in post extractive socket

  The maturation and quality of tissues will be evaluated using a modified version of the Healing Index (HI) that involves 3 scoring levels for each of the 4 parameters considered: * tissue color (1 = 100% of gingiva pink; 2 ≤ 50% of gingiva red, hyperemic, movable; 3 ≥ 50% of gingiva red, hyperemic, movable); * color and consistency of the healing tissue (1 = close grained, pink; 2 = soft, red; 3 = fragile, greenish or grayish); * suppuration (1 = absent; 2 = absent but pronounced amount of plaque around socket walls; 3 = pronounced); * bleeding (1 = absent; 2 = induced by palpation; 3 = spontaneous). The total score ranged from 4 (excellent healing) to 12 (severely impaired healing).

  14 days after tooth extraction

• Maturation and quality of tissues in post extractive socket

  The maturation and quality of tissues will be evaluated using a modified version of the Healing Index (HI) that involves 3 scoring levels for each of the 4 parameters considered: * tissue color (1 = 100% of gingiva pink; 2 ≤ 50% of gingiva red, hyperemic, movable; 3 ≥ 50% of gingiva red, hyperemic, movable); * color and consistency of the healing tissue (1 = close grained, pink; 2 = soft, red; 3 = fragile, greenish or grayish); * suppuration (1 = absent; 2 = absent but pronounced amount of plaque around socket walls; 3 = pronounced); * bleeding (1 = absent; 2 = induced by palpation; 3 = spontaneous). The total score ranged from 4 (excellent healing) to 12 (severely impaired healing).

  21 days after tooth extraction

Secondary Outcomes (7)

• NPRS

  on the day of extraction

• NPRS

  on the first day after extraction

• NPRS

  on the second day after extraction

• NPRS

  on the third day after extraction

• NPRS

  on the fourth day after extraction

Study Arms (2)

Piezoclean

Ultrasonic cavitation treatment with 0.9% sodium chloride via a specific insert (Piezoclean, Esacrom, Imola, Italy) driven by a piezoelectric device in post extractive socket

Procedure: Piezoclean

Control

Simple 0.9% sodium chloride irrigation in post extractive socket

Procedure: Control

Interventions

Piezoclean PROCEDURE

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.

Piezoclean

Control PROCEDURE

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.

Control

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

people with two single rooted hopeless teeth of the same arch to be extracted

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• International Piezosurgery Academy: lead

Study Sites (1)

University of Trieste

Trieste, TS, 34127, Italy

RECRUITING

Central Study Contacts

Claudio Stacchi, Dott.

CONTACT

+39 0403992254; claudio@stacchi.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adjunct Professor

Study Record Dates

• First Submitted: March 4, 2025
• First Posted: March 10, 2025
• Study Start: April 1, 2025
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: May 28, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)