A Triple-blinded Non-inferiority Multicentre Randomized Controlled Trial Comparing Hybrid and Fully Etched Implants P1

NCT06100120 | Unknown DMC

• 1 other identifier: RCT Hybrid vs Fully etched P1
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this randomized controlled clinical trial is to compare implant stability between hybrid implants and fully rough implants in partially edentulous patients. The main question it aims to answer is: are hybrid implants able to achieve a sufficient level of secondary stability in comparison to fully etched implants? Participants will receive dental implants and the secondary stability will be measured using resonance frequency analysis (RFA) at the 2-month post-implant placement mark. Implants that do not attain adequate secondary stability will undergo re-evaluation at monthly intervals up to 6 months. Researchers will compare the test group (hybrid implants) or the control group (fully rough implants) to see if they present a comparable secondary stability.

Conditions

Dental Implants

Keywords

Implant stability; Implant surface; Hybrid Implants

Outcome Measures

Primary Outcomes (1)

• Secondary implant stability

  Cumulative percentage of implants that achieve a successful secondary stability (ISQ\>=60)

  2 months, 3 months, 4 months, 5 months, 6 months

Secondary Outcomes (3)

• Insertion torque

  Day 0 (implant placement)

• Implant survival rate

  2 months, 3 months, 4 months, 5 months, 6 months

• Marginal bone level

  Day 0, Day of prosthesis delivery

Study Arms (2)

Hybrid implants

EXPERIMENTAL

Hybrid implants will be placed in this group

Procedure: Implant placement

Fully etched implants

ACTIVE COMPARATOR

Fully etched implants will be placed in this group

Procedure: Implant placement

Interventions

Implant placement PROCEDURE

Placement of osteointegrated implants

Fully etched implants; Hybrid implants

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Partially edentulous patients who need at least one fixed partial denture supported by 1 or 2 implants;
• Men and women over 20 years old;
• Periodontally stable patients
• Sufficient 3D bone availability
• Ideal 3D implant placement: MD: minimum tooth-implant distance of 1.5 mm and minimum inter-implant distance of 3 mm; at least 1.5 mm of buccal plate thickness; the implants should be placed equicrestally or 1 mm subcrestally in such a way that the machined part remains completely submerged; the distance between the implant neck and the adjacent dentition should be less than 6mm; straight implants (0 to 20 degrees from the adjacent tooth long axis or 70 to 90 degrees from the ridge parallelism);

You may not qualify if:

• Pregnant or lactating women;
• Uncontrolled systemic conditions;
• Patients on drugs known to interfere with the bone metabolism;
• Current smokers;
• Simultaneous/staged regenerative procedures;
• Immediate loading;
• Immediate implants;
• Short implants (\< 8 mm) or narrow implant (diameter \<3.3 mm);

Sponsors & Collaborators

• University of Milan: lead

Study Sites (1)

Clinica Odontoiatrica IRCCS Ospedale Maggiore Policlinico

Milan, MI, 20122, Italy

RECRUITING

Related Publications (5)

• Rodrigo D, Aracil L, Martin C, Sanz M. Diagnosis of implant stability and its impact on implant survival: a prospective case series study. Clin Oral Implants Res. 2010 Mar;21(3):255-61. doi: 10.1111/j.1600-0501.2009.01820.x. Epub 2009 Dec 4.

  PMID: 19958375 BACKGROUND

• Spinato S, Bernardello F, Sassatelli P, Zaffe D. Hybrid Implants in Healthy and Periodontally Compromised Patients: A Preliminary Clinical and Radiographic Study. Int J Periodontics Restorative Dent. 2017 Mar/Apr;37(2):195-202. doi: 10.11607/prd.3140.

  PMID: 28196158 BACKGROUND

• Morton D, Gallucci G, Lin WS, Pjetursson B, Polido W, Roehling S, Sailer I, Aghaloo T, Albera H, Bohner L, Braut V, Buser D, Chen S, Dawson A, Eckert S, Gahlert M, Hamilton A, Jaffin R, Jarry C, Karayazgan B, Laine J, Martin W, Rahman L, Schlegel A, Shiota M, Stilwell C, Vorster C, Zembic A, Zhou W. Group 2 ITI Consensus Report: Prosthodontics and implant dentistry. Clin Oral Implants Res. 2018 Oct;29 Suppl 16:215-223. doi: 10.1111/clr.13298.

  PMID: 30328196 BACKGROUND

• Berglundh T, Gotfredsen K, Zitzmann NU, Lang NP, Lindhe J. Spontaneous progression of ligature induced peri-implantitis at implants with different surface roughness: an experimental study in dogs. Clin Oral Implants Res. 2007 Oct;18(5):655-61. doi: 10.1111/j.1600-0501.2007.01397.x. Epub 2007 Jun 30.

  PMID: 17608738 BACKGROUND

• Sennerby L, Meredith N. Implant stability measurements using resonance frequency analysis: biological and biomechanical aspects and clinical implications. Periodontol 2000. 2008;47:51-66. doi: 10.1111/j.1600-0757.2008.00267.x. No abstract available.

  PMID: 18412573 BACKGROUND

Study Officials

• Giulio Rasperini, DDS

  University of Milan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Giulio Rasperini, DDS

CONTACT

+393358130194; giulio.rasperini@unimi.it

Study Design

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

Study Record Dates

• First Submitted: October 16, 2023
• First Posted: October 25, 2023
• Study Start: November 15, 2023
• Primary Completion: November 1, 2024
• Study Completion: January 1, 2025
• Last Updated: December 1, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)