Effect Of Cavitation In Post-Extractive Socket Healing
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorInternational Piezosurgery Academy
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
people with two single rooted hopeless teeth of the same arch to be extracted
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Piezoclean
Procedure/SurgeryFollowing 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.
Control
Procedure/SurgeryFollowing 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.
Treatment groups
84 Participants
are divided into 2 treatment groupsGroup A: Piezoclean1 intervention
Group B: Control1 intervention
Trial outcomes
Primary outcomes
1
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).
Time frame
3 days after tooth extraction2
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).
Time frame
7 days after tooth extraction3
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).
Time frame
14 days after tooth extraction4
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).
Time frame
21 days after tooth extractionSecondary outcomes
1
NPRS
The Numeric Pain Rating Scale (NPRS) is an 11-point numeric scale, ranging from 0 indicating no pain to 10 indicating worst pain imaginable.
Time frame
on the day of extraction2
NPRS
The Numeric Pain Rating Scale (NPRS) is an 11-point numeric scale, ranging from 0 indicating no pain to 10 indicating worst pain imaginable.
Time frame
on the first day after extraction3
NPRS
The Numeric Pain Rating Scale (NPRS) is an 11-point numeric scale, ranging from 0 indicating no pain to 10 indicating worst pain imaginable.
Time frame
on the second day after extraction4
NPRS
The Numeric Pain Rating Scale (NPRS) is an 11-point numeric scale, ranging from 0 indicating no pain to 10 indicating worst pain imaginable.
Time frame
on the third day after extractionSponsors and contacts
Click on the lead sponsor to view all of their trials.
International Piezosurgery Academy
Lead sponsor
University of Trieste
Sponsor institution
Source ClinicalTrials.gov