NCT07041879

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

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2024

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 17, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 27, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2026

Completed
Last Updated

December 16, 2025

Status Verified

May 1, 2025

Enrollment Period

12 months

First QC Date

May 17, 2025

Last Update Submit

December 13, 2025

Conditions

Keywords

tooth extractionimmediate implantbone healingpiezotome

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 COMPARATOR

Patients with maxillary anterior teeth will be atraumatically extracted with piezotome extraction, and subsequently immediate implant placement

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

Procedure: maxillary anterior teeth atraumatically extracted with periotome, and subsequent immediate implant placment

Interventions

piezotome extraction kit,

Atraumatic extraction with piezotome and subsequently immediate implant placement

periotome

Atraumatic extraction with periotome and subsequently immediate implant placement

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

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
Model Details: Patients with maxillary anterior teeth will be atraumatically extracted with piezotome extraction kit, and subsequently immediate implant placement
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

Locations