CavitationPiezocleanNCT06866431
Effect Of Cavitation In Post-Extractive Socket Healing
An observational study of Cavitation and Healing of Extraction Socket, run by International Piezosurgery Academy at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Cavitation, Healing of Extraction Socket
- What is being tested?
- Piezoclean
- Type of treatment
- Surgery or procedure
- How many people
- 84 participants
- Where
- 1 siteItaly
- Study dates
- 1 Apr 2025to 31 Mar 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: people with two single rooted hopeless teeth of the same arch to be extracted
Who may be able to join
- 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
Who cannot join
- 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)
Show all 9Show fewer
- Pregnancy or lactating women
- No compliance
- Extraction performed after raising a flap and/or with osteotomy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
University of Trieste
Trieste, TS, 34127
Claudio Stacchi, DDS, MSc, +39 0403992254, claudio@stacchi.it
About this study
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.
Read the detailed description
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:
- 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).
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.
- Conditions
- Cavitation, Healing of Extraction Socket
- Being tested
- Piezoclean, Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PiezocleanProcedure or surgery
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.
ControlProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Piezoclean | |
| Control | Simple 0.9% sodium chloride irrigation in post extractive socket Receives: Procedure: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 21 days after tooth extraction
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: on the sixth day after extraction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2025
- Study start1 Apr 2025
- Primary completion31 Mar 2026 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CavitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- International Piezosurgery Academy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mr. Claudio Stacchi, DDS, MSc, University of Trieste
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06866431
- Sponsor's protocol ID
- PIEZOCLEAN
- Acronym
- Piezoclean
- Status last verified
- May 2025
- First submitted
- 4 Mar 2025
- Last updated
- 28 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Of Cavitation In Post-Extractive Socket Healing
- ClinicalTrials.gov ID
- NCT06866431
- Acronym / sponsor ID
- Piezoclean / PIEZOCLEAN
- Conditions
- Cavitation, Healing of Extraction Socket
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- International Piezosurgery AcademyUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 10 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- 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).
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Piezoclean | – | Procedure: PiezocleanUltrasonic cavitation treatment with 0.9% sodium chloride via a specific insert (Piezoclean, Esacrom, Imola, Italy) driven by a piezoelectric device in post extractive socket |
| Control | – | Procedure: ControlSimple 0.9% sodium chloride irrigation in post extractive socket |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- people with two single rooted hopeless teeth of the same arch to be extracted
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PiezocleanFollowing 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. | Procedure or surgery | Piezoclean |
| ControlFollowing 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. | Procedure or surgery | Control |
Primary outcome
Maturation and quality of tissues in post extractive socket
Time frame: 3 days after tooth extraction
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).
Maturation and quality of tissues in post extractive socket
Time frame: 7 days after tooth extraction
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).
Maturation and quality of tissues in post extractive socket
Time frame: 14 days after tooth extraction
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).
Maturation and quality of tissues in post extractive socket
Time frame: 21 days after tooth extraction
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 secondary outcomes
NPRS
Time frame: on the day of extraction
NPRS
Time frame: on the first day after extraction
NPRS
Time frame: on the second day after extraction
NPRS
Time frame: on the third day after extraction
NPRS
Time frame: on the fourth day after extraction
NPRS
Time frame: on the fifth day after extraction
NPRS
Time frame: on the sixth day after extraction
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cavitation and Healing of Extraction Socket, run by International Piezosurgery Academy at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Claudio Stacchi, Dott. (+39 0403992254, claudio@stacchi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maturation and quality of tissues in post extractive socket (time frame: 3 days after tooth extraction). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2025.