Upper Central Incisor EdentulismPhase 4NCT02897193
Central Incisors Narrow Implants in Alternative to Bone Augmentation With 4.2 mm Implants .
A Phase 4 study testing ICE dental implant 4.2 mm, NICE dental implant 3.2 mm and Alpha Bio's Graft Bovine bone in people with Upper Central Incisor Edentulism, run by Alpha - Bio Tec Ltd. at 2 sites in Chile.
Trial summary
Horizontal bone augmentation procedures are commonly used to increase bone width to allow the placement of dental implants or to improve aesthetics in deficient areas. Smaller diameter implants could be used instead in order to avoid bone augmentation procedures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Upper Central Incisor Edentulism
- What is being tested?
- ICE dental implant 4.2 mm, NICE dental implant 3.2 mm and Alpha Bio's Graft Bovine bone
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 2 sitesChile
- Study dates
- Aug 2016to Dec 2019
- Phase
- Phase 4
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Upper central incisor edentulism
- bone width between 3.5-4.5 mm
- requirement of only one implant supported crown
- patient is willing to sign an informed consent
Who cannot join
- General contraindications to implant surgery.
- Immunosuppressed or immunocompromised patients
- Patients irradiated in the head and neck area.
- Patients with poor oral hygiene and motivation.
- Uncontrolled diabetes.
- Pregnancy or lactation.
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- Addiction to alcohol or drugs.
- Untreated periodontal disease.
- Treated or under treatment with intravenous amino-biphosphonates.
- Poor oral hygiene and motivation.
- Psychiatric problems and/or unrealistic expectations.
- Acute infection (abscess) or suppuration in the area intended for implant placement.
- Patients referred only for implant placement if cannot be followed at the treatment centre.
- Patient unable to attend the follow-up controls for 3 years after implant loading.
- Patient included in other studies, if this protocol cannot be properly followed.
- Immediate post-extractive sites (to be eligible at least 3 months must have passed since extraction).
Trial locations and contacts
2 sites in 1 country.
Chile2 sites
University of Antofagasta
Antofagasta
Andrés Bello National University
Santiago
About this study
Official title: 3.2 mm Diameter Implants and Soft Tissue Grafts in Alternative to Horizontal Bone Augmentation for Placing 4.2 mm Diameter Implants at Central Incisors. A Multicenter Randomised Controlled Trial
Horizontal bone augmentation procedures are commonly used to increase bone width to allow the placement of dental implants or to improve aesthetics in deficient areas. Smaller diameter implants could be used instead in order to avoid bone augmentation procedures.
The comparison between these two solutions will be evaluated in the trial.
- Conditions
- Upper Central Incisor Edentulism
- Being tested
- ICE dental implant 4.2 mm, NICE dental implant 3.2 mm, Alpha Bio's Graft Bovine bone, Alpha Bio's Graft resorbable membrane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICE dental implant 4.2 mmDevice
ICE dental implant 4.2 mm diameter
NICE dental implant 3.2 mmDevice
NICE dental implant 4.2 mm diameter
Alpha Bio's Graft Bovine boneDevice
Alpha Bio's Graft Bovine Bone
Alpha Bio's Graft resorbable membraneDevice
Alpha Bio's Graft resorbable collagen membrane
| Study group | Role | What they receive |
|---|---|---|
| Dental implant with bone augmentation | Active comparator | patients will be installed with ICE Dental implant 4.2 mm diameter with Alpha-Bio's grafts horizontal bone augmentation Receives: Device: ICE dental implant 4.2 mm; Device: Alpha Bio's Graft Bovine bone; Device: Alpha Bio's Graft resorbable membrane |
| narrow implant | Experimental | patients will be installed with NICE Dental implant 3.2 mm diameter Receives: Device: NICE dental implant 3.2 mm |
What is being measured
The primary outcome is the main question the study is designed to answer.
bone loss
bone loss level as will be measured from the radio-graphic images
Measured: 2 years
Secondary outcomes (1)
Cumulative implant survival
Counting number of survived implants at the end of the study
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2016 (estimated)
- Study startAug 2016
- Primary completionSep 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Central Incisor EdentulismStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alpha - Bio Tec Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02897193
- Sponsor's protocol ID
- ABT-ME-130815
- Status last verified
- Jun 2019
- First submitted
- 1 Sep 2016
- Last updated
- 16 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 3.2 mm Diameter Implants and Soft Tissue Grafts in Alternative to Horizontal Bone Augmentation for Placing 4.2 mm Diameter Implants at Central Incisors. A Multicenter Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT02897193
- Acronym / sponsor ID
- ABT-ME-130815
- Conditions
- Upper Central Incisor Edentulism
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Alpha - Bio Tec Ltd.Industry (pharma, biotech, devices)
- Study start
- Aug 2016
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 13 Sep 2016 (estimated)
- 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.
Horizontal bone augmentation procedures are commonly used to increase bone width to allow the placement of dental implants or to improve aesthetics in deficient areas. Smaller diameter implants could be used instead in order to avoid bone augmentation procedures.
The comparison between these two solutions will be evaluated in the trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dental implant with bone augmentation | Active comparator | Device: ICE dental implant 4.2 mm, Device: Alpha Bio's Graft Bovine bone, Device: Alpha Bio's Graft resorbable membranepatients will be installed with ICE Dental implant 4.2 mm diameter with Alpha-Bio's grafts horizontal bone augmentation |
| narrow implant | Experimental | Device: NICE dental implant 3.2 mmpatients will be installed with NICE Dental implant 3.2 mm diameter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Upper central incisor edentulism
- bone width between 3.5-4.5 mm
- requirement of only one implant supported crown
- patient is willing to sign an informed consent
Key exclusion criteria (16 listed)
- General contraindications to implant surgery.
- Immunosuppressed or immunocompromised patients
- Patients irradiated in the head and neck area.
- Patients with poor oral hygiene and motivation.
- Uncontrolled diabetes.
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 |
|---|---|---|
| ICE dental implant 4.2 mmICE dental implant 4.2 mm diameter | Device | Dental implant with bone augmentation |
| NICE dental implant 3.2 mmNICE dental implant 4.2 mm diameter | Device | narrow implant |
| Alpha Bio's Graft Bovine boneAlpha Bio's Graft Bovine Bone | Device | Dental implant with bone augmentation |
| Alpha Bio's Graft resorbable membraneAlpha Bio's Graft resorbable collagen membrane | Device | Dental implant with bone augmentation |
Primary outcome
bone loss
Time frame: 2 years
bone loss level as will be measured from the radio-graphic images
1 secondary outcome
Cumulative implant survival
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2019.
- sponsor siteLink provided by the sponsor.
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ICE dental implant 4.2 mm, NICE dental implant 3.2 mm and Alpha Bio's Graft Bovine bone in people with Upper Central Incisor Edentulism, run by Alpha - Bio Tec Ltd. at 2 sites in Chile.
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 16 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 16 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Chile. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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?
bone loss (time frame: 2 years). 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 16 Jul 2019.