Actively Recruiting
Effect of Time and Local Factors on Hydrophilic Tissue Level Implants in Post-extraction Sites: a Randomized Controlled Trial
Led by University of Rome Tor Vergata · Updated on 2025-03-28
30
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying how the design of dental implants affects their stability over time when placed in sockets after tooth extraction. This trial focuses on bone healing and implant stability by comparing two types of implants with different macro designs. The study is conducted as a randomized controlled trial to understand if the implant stability quotient (ISQ) changes based on the implant's shape and design. Participants will receive one of two implants: one with an aggressive macro design and one with a less aggressive macro design. The implants will be placed into post-extraction sockets classified as class I (with intact buccal walls). Stability will be measured by screwing a smart peg into the implant and recording ISQ values monthly for 12 months starting from the time of implant insertion. Insertion torque will also be recorded at the time the implant is placed. During the study, participants will have monthly follow-up visits for 12 months to monitor implant stability. The primary outcome is the ISQ measured monthly from insertion to one year later. Secondary outcomes include insertion torque measured at implant placement. The study includes healthy volunteers aged 18 to 99 years, with no implant or periodontal complications in neighboring teeth. Safety and implant performance will be monitored throughout the follow-up period.
CONDITIONS
Brief Title
ISQ Differences Between Different Implants in Post-extraction Sockets
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients at least 18 years old with a failing tooth
- No gum recession around the tooth to be extracted
- No periodontal bone loss of neighboring teeth
- No implants in neighboring teeth
- Class I extraction socket with intact buccal wall
- Tooth extraction must be atraumatic with intact socket walls
You will not qualify if you...
- Deep bite classified as severe II class
- Systemic diseases such as diabetes or osteoporosis
- Heavy smokers consuming more than 10 cigarettes per day
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 months
Participants receive dental implant placement and undergo implant stability quotient measurements monthly to assess implant stability.
Monthly visits for 12 months
Trial Site Locations
Total: 1 location
1
Paolo Carosi
Rome, RM, Italy, 00133
Actively Recruiting
Research Team
P
Paolo Carosi, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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