Implant StabilityNCT05141851
The Impact of Thread Length on Implant Stability
A study testing Implants with 0,7 mm threads and Implants with 0.3 mm threads in people with Implant Stability, run by University of Lisbon at 1 site in Portugal.
Trial summary
Some studies show that different types of threads in tapered implants result in differences in primary stability. The aim of this study is to a perform a prospective, controlled, randomized clinical trial comparing primary and secondary stability between long and standard thread implants in the treatment of partial… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Implant Stability
- What is being tested?
- Implants with 0,7 mm threads and Implants with 0.3 mm threads
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 sitePortugal
- Study dates
- 19 Jun 2018to 15 Jun 2020
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Minimum 18 years;
- No systemic conditions that contraindicate surgery;
- Periodontal health or periodontal disease treated as part of a periodontal support program and having a high level of plaque control;
- Partial edentulous patients, in the upper jaw, specifically in the location of premolars and molars;
Who cannot join
- Patients with insufficient quantity of bone for implant placement without bone regeneration procedures;
- Patients who underwent medication that could affect stability and osteointegration up to 3 months prior to study initiation;
- Patients with untreated periodontal pathology or who have not followed periodontal supportive treatment;
- Smokers, Pregnant or lactating women.
Trial locations and contacts
1 site in 1 country.
About this study
Some studies show that different types of threads in tapered implants result in differences in primary stability. The aim of this study is to a perform a prospective, controlled, randomized clinical trial comparing primary and secondary stability between long and standard thread implants in the treatment of partial edentulous patients.
Read the detailed description
The study sample consists of 23 maxillary partial edentulous patients, where 32 implants were placed, with threads of 0.7 mm or 0.3 mm in the location of premolars and molars. The comparison, in terms of primary stability, is made by measuring the ISQ value (implant stability quotient), in four locations (buccal, palatal, mesial and distal). Statistical analysis was performed using the independent T-Test.
- Conditions
- Implant Stability
- Being tested
- Implants with 0,7 mm threads, Implants with 0.3 mm threads
- Keywords
- implant stability; implant threads
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implants with 0,7 mm threadsDevice
Implants were placed, with threads of 0.7 mm in the location of premolars and molars.
Implants with 0.3 mm threadsDevice
Implants were placed, with threads of 0.3 mm in the location of premolars and molars.
| Study group | Role | What they receive |
|---|---|---|
| Implants with 0,7mm threads | Active comparator | Placement of Implants with 0,7mm threads Receives: Device: Implants with 0,7 mm threads |
| Implants with 0,3mm threads | Active comparator | Placement of Implants with 0,3mm threads Receives: Device: Implants with 0.3 mm threads |
What is being measured
The primary outcome is the main question the study is designed to answer.
primary dental implant stability
measuring the ISQ value (implant stability quotient)
Measured: On the 1 day of implants placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2021
- Study start19 Jun 2018
- Primary completion4 Feb 2020
- Study completion15 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Implant StabilityStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lisbon
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vanessa Rocha Rodrigues, University of Lisbon
- Investigators
- Paulo Mascarenhas, PhD, Study director, University of LisbonSusana Noronha, PhD, Study director, University of LisbonVanessa Rodrigues, Dr, Principal investigator, University of Lisbon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05141851
- Sponsor's protocol ID
- The impact of thread length on
- Status last verified
- Nov 2021
- First submitted
- 20 Nov 2021
- Last updated
- 2 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Thread Length on Implant Stability
- ClinicalTrials.gov ID
- NCT05141851
- Acronym / sponsor ID
- The impact of thread length on
- Conditions
- Implant Stability
- Keywords
- implant stability; implant threads
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of LisbonUniversity, hospital or other
- Study start
- 19 Jun 2018 (actual)
- Primary completion
- 4 Feb 2020 (actual)
- Study completion
- 15 Jun 2020 (actual)
- First posted
- 2 Dec 2021 (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.
Some studies show that different types of threads in tapered implants result in differences in primary stability. The aim of this study is to a perform a prospective, controlled, randomized clinical trial comparing primary and secondary stability between long and standard thread implants in the treatment of partial edentulous patients.
Detailed description
The study sample consists of 23 maxillary partial edentulous patients, where 32 implants were placed, with threads of 0.7 mm or 0.3 mm in the location of premolars and molars. The comparison, in terms of primary stability, is made by measuring the ISQ value (implant stability quotient), in four locations (buccal, palatal, mesial and distal). Statistical analysis was performed using the independent T-Test.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Implants with 0,7mm threads | Active comparator | Device: Implants with 0,7 mm threadsPlacement of Implants with 0,7mm threads |
| Implants with 0,3mm threads | Active comparator | Device: Implants with 0.3 mm threadsPlacement of Implants with 0,3mm threads |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Minimum 18 years;
- No systemic conditions that contraindicate surgery;
- Periodontal health or periodontal disease treated as part of a periodontal support program and having a high level of plaque control;
- Partial edentulous patients, in the upper jaw, specifically in the location of premolars and molars;
Key exclusion criteria (4 listed)
- Patients with insufficient quantity of bone for implant placement without bone regeneration procedures;
- Patients who underwent medication that could affect stability and osteointegration up to 3 months prior to study initiation;
- Patients with untreated periodontal pathology or who have not followed periodontal supportive treatment;
- Smokers, Pregnant or lactating women.
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 |
|---|---|---|
| Implants with 0,7 mm threadsImplants were placed, with threads of 0.7 mm in the location of premolars and molars. | Device | Implants with 0,7mm threads |
| Implants with 0.3 mm threadsImplants were placed, with threads of 0.3 mm in the location of premolars and molars. | Device | Implants with 0,3mm threads |
Primary outcome
primary dental implant stability
Time frame: On the 1 day of implants placement
measuring the ISQ value (implant stability quotient)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2021.
- 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.
Paulo Mascarenhas, PhD study director
University of Lisbon
Susana Noronha, PhD study director
University of Lisbon
Vanessa Rodrigues, Dr principal investigator
University of Lisbon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implants with 0,7 mm threads and Implants with 0.3 mm threads in people with Implant Stability, run by University of Lisbon at 1 site in Portugal.
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 2 Dec 2021. 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 Portugal. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
primary dental implant stability (time frame: On the 1 day of implants placement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Dec 2021.