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

November 29, 2023 updated by: Giulio Rasperini, University of Milan

A Triple-blinded Non-inferiority Multicentre Randomized Controlled Trial Comparing Hybrid and Fully Etched Implants.Part 1. Implant Stability.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a randomized triple-blinded, parallel-arm (1:1) controlled clinical trial with 6 months follow-up. Implants will be placed in 16 private practices. 128 patients will be randomly allocated to the test (hybrid implants)(64) and control (fully etched implants)(64) groups following stratified randomization in such a way that an equal number of patients in the test and in the control group will be enrolled in each study centre. The following individuals will be blinded as follows: 1) patients involved in the study will not be aware of the implants that are receiving; 2) surgeons: after the screening examination clinicians will choose the implant dimension but they will not be aware of the surface characteristic of the implant they are going to place until the implant socket is prepared; 3) the data collector/outcome assessor: of the implant stability will not be aware of the group allocation; 4) the statistician will not be aware of the group allocation. Treatment allocation will be concealed by using opaque sealed boxes and opened immediately before the implant placement (after implant socket preparation). At least 2 hours before the surgery all patients will be given antibiotic prophylaxis of 2g of amoxicillin (600mg of clindamycin for patients that allergic to penicillin). All implants (more than one implant per patient might be included) will be placed by 16 experienced surgeons in their respective clinic following according to the instruction provided by the manufacturer. The apicocoronal position of the implants will be equicrestal (i.e. the most coronal part of the machined collar is at the level of the alveolar ridge) or subcrestal (≤1 mm). In the test group and control group hybrid implants and fully etched implants (Volution, IRES®, Switzerland) will be placed. After surgery, in order to control discomfort and swelling, 600 mg ibuprofen every 8 hours if needed will be given. All subjects will be prescribed 0.12% chlorhexidine mouth rinse twice daily for 7 days. Immediately after the implant placement (Tpl) and at two months (T2) the implant stability will be measured using magnetic RFA (OsstellTM Mentor AB, Gothenburg, Sweden) by a trained clinician not involved in the study. The transducer will be screwed manually and RFA measurement were made both in the mesio-distal (MD) and bucco-lingual (BL) direction by keeping the device perpendicular at a distance between 2-4 mm and at least 3mm far away from the soft tissues. The peak insertion torque will be also registered. All implants will be submerged. Implants with ISQ values < 60 at the revaluation (T2) will undergo further measurements after 1 month till the 6th month after their placement. If at any timepoint (T2, T3, T4, T5, T6) the implant reaches a sufficient (stability ≥60) it will be considered stable till the end of the study, hence, no further ISQ assessment will be carried out and the prosthesis will be delivered (TL).

Continuous variables will be expressed as mean and standard deviation, whereas the absolute and relative frequency will be calculated for categorical variables. Regarding continuous variables, differences between groups will be tested by parametric or non-parametric test after testing the normal distribution of the data (Shapiro-Wilk test). For categorical variables chi-squared test (or Fisher test) will be adopted.

Study Type

Interventional

Enrollment (Estimated)

128

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
    • MI
      • Milan, MI, Italy, 20122
        • Recruiting
        • Clinica Odontoiatrica IRCCS Ospedale Maggiore Policlinico
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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);

Exclusion Criteria:

  • 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);

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hybrid implants
Hybrid implants will be placed in this group
Procedure: Implant placement
Placement of osteointegrated implants
Active Comparator: Fully etched implants
Fully etched implants will be placed in this group
Procedure: Implant placement
Placement of osteointegrated implants

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Secondary implant stability
Time Frame: 2 months, 3 months, 4 months, 5 months, 6 months
Cumulative percentage of implants that achieve a successful secondary stability (ISQ>=60)
2 months, 3 months, 4 months, 5 months, 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Insertion torque
Time Frame: Day 0 (implant placement)
Peak insertion torque measured during implant placement
Day 0 (implant placement)
Implant survival rate
Time Frame: 2 months, 3 months, 4 months, 5 months, 6 months
Implants still present at each time point
2 months, 3 months, 4 months, 5 months, 6 months
Marginal bone level
Time Frame: Day 0, Day of prosthesis delivery
Distance between implant shoulder and bone crest (mesial and distal)
Day 0, Day of prosthesis delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Milan

Investigators

  • Principal Investigator: Giulio Rasperini, DDS, University of Milan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 15, 2023

Primary Completion (Estimated)

November 1, 2024

Study Completion (Estimated)

January 1, 2025

Study Registration Dates

First Submitted

October 16, 2023

First Submitted That Met QC Criteria

October 20, 2023

First Posted (Actual)

October 25, 2023

Study Record Updates

Last Update Posted (Estimated)

December 1, 2023

Last Update Submitted That Met QC Criteria

November 29, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • RCT Hybrid vs Fully etched P1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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