NCT06711744

Brief Summary

Two different implants will be used in post-extraction sockets and ISQ will be recorded monthly from insertion moment to 12 months of follow up to understand if ISQ can be affected by implant macro design

Trial Health

77
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
10mo left

Started Jan 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress61%
Jan 2025Feb 2027

First Submitted

Initial submission to the registry

November 21, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 2, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

January 31, 2025

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2027

Last Updated

March 28, 2025

Status Verified

November 1, 2024

Enrollment Period

1.9 years

First QC Date

November 21, 2024

Last Update Submit

March 24, 2025

Conditions

Bone HealingImplant Stability

Outcome Measures

Primary Outcomes (1)

  • IMPLANT STABILITY QUOTIENT

    Values of risonance of implants taken by means of a dedicated device that translate the risonance of each implant into a number (0-99).

    Monthly from T0 (implant insertion) to T12 (12 months after implant placement)

Secondary Outcomes (1)

  • Insertion torque

    At implant placement

Study Arms (2)

TISSUE LEVEL X

ACTIVE COMPARATOR

Implants with aggressive macro design

Diagnostic Test: Implant stability quotient

TISSUE LEVEL C

EXPERIMENTAL

Implants with less aggressive macro design

Diagnostic Test: Implant stability quotient

Interventions

Implant stability quotientDIAGNOSTIC_TEST

Screw a smart peg into the implant and record the values from a dedicated device

TISSUE LEVEL CTISSUE LEVEL X

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients (at least 18 years old) presenting with failing tooth.
  • no recession of gingival contour of tooth to be extracted
  • no periodontal bone loss of neighboring teeth
  • no implants in neighboring teeth
  • class I extraction socket (intact buccal wall)
  • atraumatic extraction of the tooth with intact socket walls remaining.

You may not qualify if:

  • deep bite (severe II class)
  • systemic disease (diabetes, osteoporosis)
  • heavy smokers (more than 10 cigarettes/day)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Paolo Carosi

Rome, RM, 00133, Italy

RECRUITING

Central Study Contacts

Paolo Carosi, PhD

CONTACT

+393277998699paolo.carosi@alumni.uniroma2.eu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Post-doctoral Researcher

Study Record Dates

First Submitted

November 21, 2024

First Posted

December 2, 2024

Study Start

January 31, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

February 28, 2027

Last Updated

March 28, 2025

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)