ISQ Differences Between Different Implants in Post-extraction Sockets

Effect of Time and Local Factors on Hydrophilic Tissue Level Implants in Post-extraction Sites: a RCT

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

Study Overview

• Status: Recruiting
• Conditions: Implant Stability; Bone Healing
• Intervention / Treatment: Diagnostic test: Implant stability quotient

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Paolo Carosi, PhD; Phone Number: +393277998699; Email: paolo.carosi@alumni.uniroma2.eu

Study Locations

• Italy
  • RM
    • Rome, RM, Italy, 00133
      • Recruiting
      • Paolo Carosi
      • Contact: Paolo Carosi, PhD; Phone Number: 3277998699; Email: carosipaolo29@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: TISSUE LEVEL X; Implants with aggressive macro design	Diagnostic test: Implant stability quotient; Screw a smart peg into the implant and record the values from a dedicated device
Experimental: TISSUE LEVEL C; Implants with less aggressive macro design	Diagnostic test: Implant stability quotient; Screw a smart peg into the implant and record the values from a dedicated device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Insertion torque	Mechanical resistance of the bone at implant placement	At implant placement

Collaborators and Investigators

• Sponsor: University of Rome Tor Vergata

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): February 28, 2027

Study Registration Dates

• First Submitted: November 21, 2024
• First Submitted That Met QC Criteria: November 26, 2024
• First Posted (Actual): December 2, 2024

Study Record Updates

• Last Update Posted (Actual): March 28, 2025
• Last Update Submitted That Met QC Criteria: March 24, 2025
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: TLCVSTLX

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No