An observational study in Cavitation and Healing of Extraction Socket, sponsored by International Piezosurgery Academy. Recruiting at 1 site in Italy. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2025-05-28.
Sponsored by International Piezosurgery Academy · Observational
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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.
Methods: Subjects referring to the clinical centers with the clinical indication of extraction of two contralateral single-rooted teeth of the same arch are suitable for enrollment. Teeth to be extracted should be characterized by the following condition: deep unrecoverable decay; untreatable endodontic issue; untreatable crow-root fracture.
The same surgical extractive protocol will be performed in both sites. 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.
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. All patients will be instructed in post-extractive domiciliary care. Paracetamol 1g every 8 hours in case of pain will be prescribed.
Patients will be given a questionnaire to fill out daily, entering a score on the NPRS (from 1 to 10) for 7 days, where a score of 0 indicates "no pain" and a score of 10 indicates "very severe pain", along with the number of paracetamol intakes per day. Follow-ups will be scheduled for day-3, day-7 for suture removal, day-14, day 21 for final check.
On day 3, day 7, day 14 and day 21 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:
Study design: Prospective randomized clinical trial.
Study population: The study will be conducted in an outpatient hospital setting.
Subject numerosity: The outcome of the study involves the evaluation of the application of cavitation effect via piezoelectric device on post-extractive sockets.
To date, there are no studies in the literature reporting results regarding the application of cavitation that may be used for an adequate sample size calculation.
Therefore, a minimal clinically important difference (MCID) was considered to be a difference between the means of the group 1 and the group 2 of 0.5 points on NPRS at T1 (3gg), with a standard deviation of 1 point. With alpha set at 0.05 and power set at 0.8, a sample size of 62 statistical units per group was calculated.
Each center will treat 12 patients with bilateral extractions (7 centers = 84 patients), to compensate possible drop-outs during the study.
Enrollment procedure: all patients who meet the inclusion and exclusion criteria will be enrolled in the study following the administration of the Information Sheet and the acquisition of informed consent.
Data collection: Data will be entered in an Excel database, which can be accessed using specific usernames and passwords in the possession of the staff involved in the study. The data will be entered anonymously by associating a numeric ID to each patient.
Data analysis: Statistical analysis will be performed by means of a computerized statistical package (SigmaStat 3.5, SPSS Inc., Germany). Data will be expressed as mean ± SD and median (interquartile range), respectively, for parametric and nonparametric values. Data will be normalized and difference in NPRS between the treatments at the various timepoints will be analyzed with descriptive statistics to assess whether they have a normal distribution; both equal variance and normality tests will be used. Hypotheses will be tested using unpaired t-test in case of normally distributed data, while Mann-Whitney U-test will be performed to compare nonparametric values.
International Piezosurgery Academy is the lead sponsor of 24 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
people with two single rooted hopeless teeth of the same arch to be extracted
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Simple 0.9% sodium chloride irrigation in post extractive socket
Procedure: Control
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.
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.
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 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).
Time frame: 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).
Time frame: 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).
Time frame: 21 days after tooth extraction
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 extraction
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 extraction
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 extraction
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 extraction
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 fourth day after extraction
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 fifth day after extraction
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 sixth day after extraction
Plan to share: No
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Started Apr 2025 (actual). Primary completion is estimated for Mar 2026, 11 months after the start.
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International Piezosurgery Academy