PiezotomeNCT07041879
Piezotome Atraumatic Tooth Extraction And Immediate Implant Placement In Maxillary Anterior Region
A study testing maxillary anterior teeth atraumatically extracted with piezotome extraction kit, and subsequent immediate implant placement and maxillary anterior teeth atraumatically extracted with periotome, and subsequent immediate implant placment in people with Piezotome and Implant-supported Single Crowns, run by Alexandria University at 1 site in Egypt.
Trial summary
Tooth extraction is critical for dental treatment complications followed by immediate implant placement to restore the extracted tooth . The use of devices or instruments such as piezotome and periotome as aids in atraumatic surgical proceduresو conserving both bone and soft tissue, allowing extraction without… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Piezotome, Implant-supported Single Crowns
- What is being tested?
- maxillary anterior teeth atraumatically extracted with piezotome extraction kit, and subsequent immediate implant placement and maxillary anterior teeth atraumatically extracted with periotome, and subsequent immediate implant placment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2024to 30 Mar 2026
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients of both gender with a non-restorable maxillary anterior tooth in the aesthetic zone indicated for extraction and subsequent immediate implant placement. Including those with:
- Severely carious tooth that it cannot be restored.
- Pulpal necrosis or irreversible pulpitis that is not amenable to endodontics.
- Periodontally involved Tooth with grade 2 mobility or above.
- Tooth with root caries that can't be restored.
- Patients with extraction socket Type I, according to Elian's classification
Who cannot join
- Patients with extraction socket Type II or III, with defect in the buccal plate
- Patients with deciduous teeth.
- Heavy smokers.
- Medically compromised patients with conditions that would impede implant osteointegration and healing.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Dentistry, Alexandria University
Alexandria, Alexandria Governorate
About this study
Official title: Piezotome Atraumatic Tooth Extraction And Immediate Implant Placement In Maxillary Anterior Region: Randomized Clinical Trial
Tooth extraction is critical for dental treatment complications followed by immediate implant placement to restore the extracted tooth . The use of devices or instruments such as piezotome and periotome as aids in atraumatic surgical proceduresو conserving both bone and soft tissue, allowing extraction without unnecessary socket expansion. Immediate implant placement into fresh extraction sockets offers some esthetic and functional advantages.
the Aim of this study is to compare and evaluate the effectiveness of the piezotome and periotome as aids for atraumatic extraction in immediate implant placement in maxillary anterior teeth.
Read the detailed description
30 patients with non-restorable maxillary anterior teeth will be included. Teeth will be extracted using an atraumatic tooth extraction using piezotome and periotome as aids in atraumatic surgical procedures. After that an immediate implant will be placed into the fresh extraction socket . patients will be recalled for follow-up 3months after implant placement to evaluate pain by VAS and evaluate bone healing using CBCT.
- Conditions
- Piezotome, Implant-supported Single Crowns
- Being tested
- maxillary anterior teeth atraumatically extracted with piezotome extraction kit, and subsequent immediate implant placement, maxillary anterior teeth atraumatically extracted with periotome, and subsequent immediate implant placment
- Keywords
- tooth extraction, immediate implant, bone healing, piezotome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
maxillary anterior teeth atraumatically extracted with piezotome extraction kit, and subsequent immediate implant placementProcedure or surgery
piezotome extraction kit,
maxillary anterior teeth atraumatically extracted with periotome, and subsequent immediate implant placmentProcedure or surgery
periotome
| Study group | Role | What they receive |
|---|---|---|
| Atraumatic extraction with piezotome and subsequently immediate implant placement | Active comparator | Patients with maxillary anterior teeth will be atraumatically extracted with piezotome extraction, and subsequently immediate implant placement Receives: Procedure: maxillary anterior teeth atraumatically extracted with piezotome extraction kit, and subsequent immediate implant placement |
| Atraumatic extraction with periotome and subsequently immediate implant placement | Experimental | Patients with maxillary anterior teeth will be atraumatically extracted with periotome, and subsequently immediate implant placement Receives: Procedure: maxillary anterior teeth atraumatically extracted with periotome, and subsequent immediate implant placment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic assessment of the management of the crestal bone width and changes in labial bone thickness.
A postoperative CBCT will be taken within 24 hours of implant placement followed by a 6-months scan, and values will be compared with the preoperative record. The assessment will be conducted using the tools on the "On Demand 3D App." Software*. The following criteria will be assessed:
Measured: 5 months
Secondary outcomes (1)
Clinical Wound Healing
All patients will be recalled for a clinical follow-up period at 7, 14, and 21 days postoperative for the assessment of Wound healing using the Pink Esthetic Score (PES)
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2025
- Study start1 Oct 2024
- Primary completion30 Sep 2025
- Study completion30 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PiezotomeStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients with maxillary anterior teeth will be atraumatically extracted with piezotome extraction kit, and subsequently immediate implant placement
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07041879
- Sponsor's protocol ID
- ATE-17-5-25
- Status last verified
- May 2025
- First submitted
- 17 May 2025
- Last updated
- 16 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: all data will be de-identified to protect the participant data. patients signed an informed consent for the use of their medical records and data for study
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Piezotome Atraumatic Tooth Extraction And Immediate Implant Placement In Maxillary Anterior Region: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07041879
- Acronym / sponsor ID
- ATE-17-5-25
- Conditions
- Piezotome, Implant-supported Single Crowns
- Keywords
- tooth extraction, immediate implant, bone healing, piezotome
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 30 Mar 2026 (estimated)
- First posted
- 27 Jun 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.
Tooth extraction is critical for dental treatment complications followed by immediate implant placement to restore the extracted tooth . The use of devices or instruments such as piezotome and periotome as aids in atraumatic surgical proceduresو conserving both bone and soft tissue, allowing extraction without unnecessary socket expansion. Immediate implant placement into fresh extraction sockets offers some esthetic and functional advantages.
the Aim of this study is to compare and evaluate the effectiveness of the piezotome and periotome as aids for atraumatic extraction in immediate implant placement in maxillary anterior teeth.
Detailed description
30 patients with non-restorable maxillary anterior teeth will be included. Teeth will be extracted using an atraumatic tooth extraction using piezotome and periotome as aids in atraumatic surgical procedures. After that an immediate implant will be placed into the fresh extraction socket . patients will be recalled for follow-up 3months after implant placement to evaluate pain by VAS and evaluate bone healing using CBCT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Patients with maxillary anterior teeth will be atraumatically extracted with piezotome extraction kit, and subsequently immediate implant placement
| Arm | Type | Receives |
|---|---|---|
| Atraumatic extraction with piezotome and subsequently immediate implant placement | Active comparator | Procedure: maxillary anterior teeth atraumatically extracted with piezotome extraction kit, and subsequent immediate implant placementPatients with maxillary anterior teeth will be atraumatically extracted with piezotome extraction, and subsequently immediate implant placement |
| Atraumatic extraction with periotome and subsequently immediate implant placement | Experimental | Procedure: maxillary anterior teeth atraumatically extracted with periotome, and subsequent immediate implant placmentPatients with maxillary anterior teeth will be atraumatically extracted with periotome, and subsequently immediate implant placement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients of both gender with a non-restorable maxillary anterior tooth in the aesthetic zone indicated for extraction and subsequent immediate implant placement. Including those with:
- Patients with extraction socket Type I, according to Elian's classification
Key exclusion criteria (4 listed)
- Patients with extraction socket Type II or III, with defect in the buccal plate
- Patients with deciduous teeth.
- Heavy smokers.
- Medically compromised patients with conditions that would impede implant osteointegration and healing.
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 |
|---|---|---|
| maxillary anterior teeth atraumatically extracted with piezotome extraction kit, and subsequent immediate implant placementpiezotome extraction kit, | Procedure or surgery | Atraumatic extraction with piezotome and subsequently immediate implant placement |
| maxillary anterior teeth atraumatically extracted with periotome, and subsequent immediate implant placmentperiotome | Procedure or surgery | Atraumatic extraction with periotome and subsequently immediate implant placement |
Primary outcome
Radiographic assessment of the management of the crestal bone width and changes in labial bone thickness.
Time frame: 5 months
A postoperative CBCT will be taken within 24 hours of implant placement followed by a 6-months scan, and values will be compared with the preoperative record. The assessment will be conducted using the tools on the "On Demand 3D App." Software*. The following criteria will be assessed:
1 secondary outcome
Clinical Wound Healing
Time frame: 21 days
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 16 Dec 2025.
- Individual participant dataSharing planned: No. all data will be de-identified to protect the participant data. patients signed an informed consent for the use of their medical records and data for study
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing maxillary anterior teeth atraumatically extracted with piezotome extraction kit, and subsequent immediate implant placement and maxillary anterior teeth atraumatically extracted with periotome, and subsequent immediate implant placment in people with Piezotome and Implant-supported Single Crowns, run by Alexandria University at 1 site in Egypt.
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 6 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 16 Dec 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 Egypt. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiographic assessment of the management of the crestal bone width and changes in labial bone thickness. (time frame: 5 months). 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 16 Dec 2025.