Piezotome Atraumatic Tooth Extraction And Immediate Implant Placement In Maxillary Anterior Region
1 other identifier
interventional
30
1 country
1
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2024
CompletedFirst Submitted
Initial submission to the registry
May 17, 2025
CompletedFirst Posted
Study publicly available on registry
June 27, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2026
CompletedDecember 16, 2025
May 1, 2025
12 months
May 17, 2025
December 13, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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:
5 months
Secondary Outcomes (1)
Clinical Wound Healing
21 days
Study Arms (2)
Atraumatic extraction with piezotome and subsequently immediate implant placement
ACTIVE COMPARATORPatients 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
EXPERIMENTALPatients with maxillary anterior teeth will be atraumatically extracted with periotome, and subsequently immediate implant placement
Interventions
piezotome extraction kit,
periotome
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Faculty of Dentistry, Alexandria University
Alexandria, Alexandria Governorate, Egypt
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- Sequentially numbered, opaque, sealed envelopes (SNOSE) allocation concealment method will be utilized. Each participant included in the study will be given a serial number that will be used in the allocation. These numbers will be written in identical sheets of paper with the group to which each participant is allocated and placed inside opaque envelopes carrying the respective names of participants. A trial independent personnel will be assigned the role of keeping the envelopes and unfolding them only at the time of the operation, so that the participant is allocated to a group which is concealed from the operator
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 17, 2025
First Posted
June 27, 2025
Study Start
October 1, 2024
Primary Completion
September 30, 2025
Study Completion
March 30, 2026
Last Updated
December 16, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will not share
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