Status unknownNCT03845335HAHy-vs-CUpdated Jun 14, 2022

Clinical Performance Evaluation of Two Different Dental Implants

An interventional study of dental implant-supported restoration in Edentulism, sponsored by Elite Odontoiatrica. Status unknown at 4 sites in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-06-14.

Sponsored by Elite Odontoiatrica · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2022), so the status shown — last known as Active, not recruiting — may be out of date.

Phase: Not applicable
Study type: Interventional
Enrollment: 600
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study 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.

Conditions studied

Edentulism

In context

Lead sponsor

This is the only study on the registry with Elite Odontoiatrica as lead sponsor.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Eligibility criteria

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.

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Triple (Participant, Investigator, Outcomes assessor)
Enrollment: 600 participants (estimated)

Study arms

Experimental
HA-coated hybrid implant
Patient allocated to this group will receive an iMAX® Hyaluronic Acid-coated hybrid dental implant for their dental implant-supported restoration.
Device: dental implant-supported restoration
Active comparator
Moderately rough implant
Patient allocated in this group will receive an iMAX® non-coated moderately rough dental implant with a machined neck their dental implant-supported restoration.
Device: dental implant-supported restoration

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

What researchers measure

Primary outcomes

Survival Rate
Cumulative implant survival rate
Time frame: 12 months after implant placement

Study locations

4 sites

Elite Odontoiatrica Magenta
Magenta, MI, Italy
Elite Odontoiatrica Milano
Milano, MI, Italy
Elite Odontoiatrica Opera
Opera, MI, Italy
Elite Odontoiatrica Caronno
Caronno Pertusella, VA, Italy

References and documents

Publications

Berglundh T, Armitage G, Araujo MG, Avila-Ortiz G, Blanco J, Camargo PM, Chen S, Cochran D, Derks J, Figuero E, Hammerle CHF, Heitz-Mayfield LJA, Huynh-Ba G, Iacono V, Koo KT, Lambert F, McCauley L, Quirynen M, Renvert S, Salvi GE, Schwarz F, Tarnow D, Tomasi C, Wang HL, Zitzmann N. Peri-implant diseases and conditions: Consensus report of workgroup 4 of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions. J Clin Periodontol. 2018 Jun;45 Suppl 20:S286-S291. doi: 10.1111/jcpe.12957. PubMed 29926491 ↗
de Bruyn H, Collaert B, Linden U, Bjorn AL. Patient's opinion and treatment outcome of fixed rehabilitation on Branemark implants. A 3-year follow-up study in private dental practices. Clin Oral Implants Res. 1997 Aug;8(4):265-71. doi: 10.1034/j.1600-0501.1997.080403.x. PubMed 9586472 ↗
Jung RE, Pjetursson BE, Glauser R, Zembic A, Zwahlen M, Lang NP. A systematic review of the 5-year survival and complication rates of implant-supported single crowns. Clin Oral Implants Res. 2008 Feb;19(2):119-30. doi: 10.1111/j.1600-0501.2007.01453.x. Epub 2007 Dec 7. PubMed 18067597 ↗
Lang NP, Zitzmann NU; Working Group 3 of the VIII European Workshop on Periodontology. Clinical research in implant dentistry: evaluation of implant-supported restorations, aesthetic and patient-reported outcomes. J Clin Periodontol. 2012 Feb;39 Suppl 12:133-8. doi: 10.1111/j.1600-051X.2011.01842.x. PubMed 22533953 ↗
Meijndert L, Meijer HJ, Stellingsma K, Stegenga B, Raghoebar GM. Evaluation of aesthetics of implant-supported single-tooth replacements using different bone augmentation procedures: a prospective randomized clinical study. Clin Oral Implants Res. 2007 Dec;18(6):715-9. doi: 10.1111/j.1600-0501.2007.01415.x. Epub 2007 Sep 20. PubMed 17888016 ↗
Pjetursson BE, Tan K, Lang NP, Bragger U, Egger M, Zwahlen M. A systematic review of the survival and complication rates of fixed partial dentures (FPDs) after an observation period of at least 5 years. Clin Oral Implants Res. 2004 Dec;15(6):625-42. doi: 10.1111/j.1600-0501.2004.01117.x. PubMed 15533124 ↗
Pjetursson BE, Tan WC, Zwahlen M, Lang NP. A systematic review of the success of sinus floor elevation and survival of implants inserted in combination with sinus floor elevation. J Clin Periodontol. 2008 Sep;35(8 Suppl):216-40. doi: 10.1111/j.1600-051X.2008.01272.x. PubMed 18724852 ↗

Individual participant data

Plan to share: Undecided

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jun 14, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03845335
Lead sponsor: Elite Odontoiatrica
Responsible party: Luca Ferrantino (Researcher, Elite Odontoiatrica) — Principal investigator
First posted: Feb 19, 2019
Start date: Feb 25, 2019
Primary completion: Dec 2022 (estimated)
Completion: Jul 2023 (estimated)
Last update: Jun 14, 2022

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.

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