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Clinical Performance Evaluation of Two Different Dental Implants

Clinical Performance Evaluation of a Hyaluronic Acid-coated Hybrid Dental Implant Compared to a Non-Coated Standard Rough Dental Implant: A Pragmatic Multi-center Randomized Controlled Trial

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03845335
Acronym
HAHy-vs-C
Enrollment
600
Registered
2019-02-19
Start date
2019-02-25
Completion date
2023-07-31
Last updated
2022-06-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Edentulism

Brief summary

In brief, the aim of this randomized controlled trial is to evaluate the patient satisfaction and the clinical performance of two types of implants: 1) HA-coated hybrid dental implant and 2) non-coated moderately rough dental implant. The comparison will be studied during a routine implant placement of experienced dental implantologists.

Interventions

DEVICEdental implant-supported restoration

During the oral surgery session for dental implant insertion, after implant site preparation, the opaque sealed envelope containing the patient allocation will be opened. Following the group allocation, the patient will receive either an HA-coated Hybrid or moderately rough dental implant

Sponsors

Elite Odontoiatrica
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Masking description

Both patients and clinicians will be unaware of treatment allocation until the randomization sequence is disclosed. Clinician who will perform test and control treatment will know the group allocation. Clinician who will do the outcome evaluation will be unaware of the treatment allocation. A blinded researcher will perform data analysis.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Signed informed consent to participate to the present investigation * Psychological appropriateness and good compliance to dentist instructions * Patient who have been selected for implant therapy by an experienced surgeon.

Design outcomes

Primary

MeasureTime frameDescription
Survival Rate12 months after implant placementCumulative implant survival rate

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026