Dental ImplantsNCT06100120
A Triple-blinded Non-inferiority Multicentre Randomized Controlled Trial Comparing Hybrid and Fully Etched Implants P1
A study testing Implant placement in people with Dental Implants, run by University of Milan at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental Implants
- What is being tested?
- Implant placement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteItaly
- Study dates
- 15 Nov 2023to 1 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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);
Who cannot join
- 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);
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Clinica Odontoiatrica IRCCS Ospedale Maggiore Policlinico
Milan, MI, 20122
Giulio Rasperini, Professor, +393358130194, giulio.rasperini@unimi.it
About this study
Official title: 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.
Read the 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.
- Conditions
- Dental Implants
- Being tested
- Implant placement
- Keywords
- Implant stability, Implant surface, Hybrid Implants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implant placementProcedure or surgery
Placement of osteointegrated implants
| Study group | Role | What they receive |
|---|---|---|
| Hybrid implants | Experimental | Hybrid implants will be placed in this group Receives: Procedure: Implant placement |
| Fully etched implants | Active comparator | Fully etched implants will be placed in this group Receives: Procedure: Implant placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Secondary implant stability
Cumulative percentage of implants that achieve a successful secondary stability (ISQ>=60)
Measured: 2 months, 3 months, 4 months, 5 months, 6 months
Secondary outcomes (3)
Insertion torque
Peak insertion torque measured during implant placement
Measured: Day 0 (implant placement)
Implant survival rate
Implants still present at each time point
Measured: 2 months, 3 months, 4 months, 5 months, 6 months
Marginal bone level
Distance between implant shoulder and bone crest (mesial and distal)
Measured: Day 0, Day of prosthesis delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2023
- Study start15 Nov 2023
- Primary completion1 Nov 2024 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Dental ImplantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Milan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giulio Rasperini, University of Milan
- Investigators
- Giulio Rasperini, DDS, Principal investigator, University of Milan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06100120
- Sponsor's protocol ID
- RCT Hybrid vs Fully etched P1
- Status last verified
- Nov 2023
- First submitted
- 16 Oct 2023
- Last updated
- 1 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 19958375Spinato 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.
PubMed 28196158Morton 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.
PubMed 30328196Berglundh 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.
PubMed 17608738Sennerby 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.
PubMed 18412573
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Triple-blinded Non-inferiority Multicentre Randomized Controlled Trial Comparing Hybrid and Fully Etched Implants.Part 1. Implant Stability.
- ClinicalTrials.gov ID
- NCT06100120
- Acronym / sponsor ID
- RCT Hybrid vs Fully etched P1
- Conditions
- Dental Implants
- Keywords
- Implant stability, Implant surface, Hybrid Implants
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- University of MilanUniversity, hospital or other
- Study start
- 15 Nov 2023 (actual)
- Primary completion
- 1 Nov 2024 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 25 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hybrid implants | Experimental | Procedure: Implant placementHybrid implants will be placed in this group |
| Fully etched implants | Active comparator | Procedure: Implant placementFully etched implants will be placed in this group |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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);
Key exclusion criteria (8 listed)
- Pregnant or lactating women;
- Uncontrolled systemic conditions;
- Patients on drugs known to interfere with the bone metabolism;
- Current smokers;
- Simultaneous/staged regenerative procedures;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implant placementPlacement of osteointegrated implants | Procedure or surgery | Fully etched implants, Hybrid implants |
Primary outcome
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)
3 secondary outcomes
Insertion torque
Time frame: Day 0 (implant placement)
Implant survival rate
Time frame: 2 months, 3 months, 4 months, 5 months, 6 months
Marginal bone level
Time frame: Day 0, Day of prosthesis delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2023.
- Background: PubMed 19958375Rodrigo 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.
- Background: PubMed 28196158Spinato 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.
- Background: PubMed 30328196Morton 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.
- Background: PubMed 17608738Berglundh 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.
- Background: PubMed 18412573Sennerby 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giulio Rasperini, DDS principal investigator
University of Milan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implant placement in people with Dental Implants, run by University of Milan at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Giulio Rasperini, DDS (+393358130194, giulio.rasperini@unimi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Secondary implant stability (time frame: 2 months, 3 months, 4 months, 5 months, 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06100120, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2023.