Actively Recruiting
Clinical Influence of Different Surface Treatments on Implant Stability: a Prospective Observational Clinical Study
Led by International Piezosurgery Academy · Updated on 2025-02-05
32
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
Sponsors
I
International Piezosurgery Academy
Lead Sponsor
U
University of Trieste
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to monitor the stability of dental implants placed in the premolar area using different surface treatments: vacuum-plasma activation, ozonated oil, and no surface treatment. The study is observational and assesses how these treatments influence both primary and secondary implant stability, as well as early bone loss around the implant. It is conducted at two different clinical sites with patients needing implant-supported rehabilitation due to missing teeth. Participants receive implants after local anesthesia and minimally invasive surgery. Implants are assigned to one of three groups: treated with ozonated oil, treated with vacuum-plasma activation, or without any surface treatment. Each implant is placed into prepared bone, followed by attaching a transepithelial abutment tightened to a specific torque. Sutures close the surgical site, and radiographic checks confirm implant positioning. Follow-up occurs at multiple intervals up to 90 days, with implants restored by crowns after four months and monitored for at least one year post-loading. During the study, implant stability is measured immediately after placement and repeatedly during follow-up visits using a Resonance Frequency Analysis device. Bone levels around the implants are tracked at surgery, crown placement, and one year later to assess marginal bone loss. Participants attend scheduled visits for healing assessment, suture removal, and stability measurements. Safety, complications, and implant survival are also recorded. The total study duration includes at least one year of post-restoration monitoring.
CONDITIONS
Brief Title
Clinical Influence of Different Surface Treatments on Implant Stabiity
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age older than 18 years old
- Need for implant-supported rehabilitation in the left and right upper premolar or first molar areas
- At least 6 months of healing in the implant placement area
- No use of grafts or bone substitutes after tooth extraction
- Bone volume of at least 10 mm in height and 6 mm in width
- Not wearing or choosing not to wear removable prosthesis during healing
- Good and stable oral hygiene
- Signed informed consent form
You will not qualify if you...
- Acute myocardial infarction within the previous six months
- Uncontrolled bleeding disorders
- Uncontrolled diabetes with HBA1c over 7.5%
- Radiotherapy in the head or neck area within the past 48 months
- Immunocompromised conditions such as AIDS or chemotherapy
- Current or past treatment with intravenous antiresorptive drugs
- Psychological or psychiatric diseases
- Alcohol or drug abuse
- Heavy smoking (more than 10 cigarettes per day)
- Poor oral hygiene with plaque index above 20% or bleeding on probing above 10%
- Pregnancy or breastfeeding
- Refusal to participate in follow-up visits
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 to 2 visits including radiographic evaluations (periapical radiograph and CBCT) to assess bone adequacy
Duration - 1 day
Participants undergo implant placement with one of the surface treatments or no treatment under local anesthesia. A minimally invasive full-thickness flap is elevated, and the implant is inserted into the prepared site followed by abutment attachment and suturing.
1 visit (in-person) for implant placement
Duration - 90 days
Participants have follow-up visits for suture removal, soft tissue healing assessment, and implant stability measurements. Additional follow-ups monitor implant secondary stability and healing over the first 90 days.
Weekly visits at 7, 14, 21, 28, 42, 56, and 90 days after implant placement
Duration - At least 12 months after prosthetic loading
Participants receive screw-retained single metal-ceramic crowns four months after surgery and are monitored for implant survival and bone levels with radiographic check-ups.
Radiographic assessments at 6 months and 1 year post-loading
Trial Site Locations
Total: 1 location
1
University of Trieste
Trieste, TS, Italy, 34125
Actively Recruiting
Research Team
C
Claudio Stacchi, Dott.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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