Clinical Performance Evaluation of Two Different Dental Implants

NCT03845335 | Unknown

• 1 other identifier: Protocol 01
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 4

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.

Conditions

Edentulism

Outcome Measures

Primary Outcomes (1)

• Survival Rate

  Cumulative implant survival rate

  12 months after implant placement

Study Arms (2)

HA-coated hybrid implant

EXPERIMENTAL

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

Moderately rough implant

ACTIVE COMPARATOR

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

dental implant-supported restoration DEVICE

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

HA-coated hybrid implant; Moderately rough implant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Elite Odontoiatrica: lead

Study Sites (4)

Elite Odontoiatrica Magenta

Magenta, MI, Italy

Location

Elite Odontoiatrica Milano

Milan, MI, Italy

Location

Elite Odontoiatrica Opera

Opera, MI, Italy

Location

Elite Odontoiatrica Caronno

Caronno Pertusella, VA, Italy

Location

Related Publications (7)

• 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.

  PMID: 29926491 BACKGROUND

• 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.

  PMID: 9586472 BACKGROUND

• 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.

  PMID: 18067597 BACKGROUND

• 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.

  PMID: 22533953 BACKGROUND

• 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.

  PMID: 17888016 BACKGROUND

• 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.

  PMID: 15533124 BACKGROUND

• 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.

  PMID: 18724852 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: February 15, 2019
• First Posted: February 19, 2019
• Study Start: February 25, 2019
• Primary Completion: December 1, 2022
• Study Completion: July 1, 2023
• Last Updated: June 14, 2022

Record last verified: 2022-06

Locations

IT (4)