Fresh Sockets With Buccal ResorptionIDRBio-ossNCT03202030
Immediate Dentoalveolar Restoration Compared to Bio-oss
A study testing Immediate dentoalveolar restoration and Demineralized bovine bone in people with Fresh Sockets With Buccal Resorption, run by Federal University of Rio Grande do Sul at 1 site in Uruguay.
Trial summary
This randomised controlled trial compares the immediate dentoalveolar restoration and bovine demineralised bone in immediate implants placed in fresh sockets with buccal resorption. A total of 34 patients will be included and followed clinically and radiographically for 18 months. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Fresh Sockets With Buccal Resorption
- What is being tested?
- Immediate dentoalveolar restoration and Demineralized bovine bone
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUruguay
- Study dates
- Jan 2016to Jan 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Tooth extraction indicated for teeth in anterior area between second premolars
Who cannot join
- Diabetes and other systemic conditions that may affect osseointegration
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immediate Dentoalveolar Restoration Compared to Demineralized Bovine Bone in Immediate Implants Placed in Fresh Sockets With Buccal Bone Resorption: 18-months Randomized Controlled Trial
This randomised controlled trial compares the immediate dentoalveolar restoration and bovine demineralised bone in immediate implants placed in fresh sockets with buccal resorption. A total of 34 patients will be included and followed clinically and radiographically for 18 months. Patient centred outcomes will also be evaluated.
- Conditions
- Fresh Sockets With Buccal Resorption
- Being tested
- Immediate dentoalveolar restoration, Demineralized bovine bone
- Keywords
- immediate dentoalveolar restoration, bio-oss, immediate dental implant, bovine bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate dentoalveolar restorationProcedure or surgery
Also called IDR
Block of bone removed from the tuber and placed in the buccal resorption of the socket together with an immediate implant
Demineralized bovine boneProcedure or surgery
Block of demineralised bovine bone placed in the buccal resorption of the socket together with an immediate implant
| Study group | Role | What they receive |
|---|---|---|
| IDR | Experimental | Immediate dentoalveolar restoration conducted with bone removed from the tuber Receives: Procedure: Immediate dentoalveolar restoration |
| Bio-oss | Active comparator | Bovine demineralized bone (Bio-oss Collagen) applied on the buccal resorption of the immediate implant Receives: Procedure: Demineralized bovine bone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Buccal-palatal thickness
Measured: 18 months
Secondary outcomes (1)
Oral-health related quality of life
The OHIP-14 will be applied and satisfaction will also be recorded
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2017
- Study startJan 2016
- Primary completionDec 2018
- Study completionJan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fresh Sockets With Buccal ResorptionStudies 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
- Investigator
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Rio Grande do Sul
- Sponsor type
- University, hospital or other
- Collaborators
- University of the Republic, Uruguay
- Responsible party
- Principal investigator, Alex Nogueira Haas, Federal University of Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03202030
- Sponsor's protocol ID
- Udelar
- Acronym
- IDRBio-oss
- Status last verified
- May 2022
- First submitted
- 26 Jun 2017
- Last updated
- 11 May 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Dentoalveolar Restoration Compared to Demineralized Bovine Bone in Immediate Implants Placed in Fresh Sockets With Buccal Bone Resorption: 18-months Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03202030
- Acronym / sponsor ID
- IDRBio-oss / Udelar
- Conditions
- Fresh Sockets With Buccal Resorption
- Keywords
- immediate dentoalveolar restoration, bio-oss, immediate dental implant, bovine bone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Federal University of Rio Grande do SulUniversity, hospital or other
- Collaborators
- University of the Republic, Uruguay
- Study start
- Jan 2016 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Jan 2020 (actual)
- First posted
- 28 Jun 2017 (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.
This randomised controlled trial compares the immediate dentoalveolar restoration and bovine demineralised bone in immediate implants placed in fresh sockets with buccal resorption. A total of 34 patients will be included and followed clinically and radiographically for 18 months. Patient centred outcomes will also be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IDR | Experimental | Procedure: Immediate dentoalveolar restorationImmediate dentoalveolar restoration conducted with bone removed from the tuber |
| Bio-oss | Active comparator | Procedure: Demineralized bovine boneBovine demineralized bone (Bio-oss Collagen) applied on the buccal resorption of the immediate implant |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Tooth extraction indicated for teeth in anterior area between second premolars
Key exclusion criteria (1 listed)
- Diabetes and other systemic conditions that may affect osseointegration
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 |
|---|---|---|
| Immediate dentoalveolar restorationAlso: IDRBlock of bone removed from the tuber and placed in the buccal resorption of the socket together with an immediate implant | Procedure or surgery | IDR |
| Demineralized bovine boneBlock of demineralised bovine bone placed in the buccal resorption of the socket together with an immediate implant | Procedure or surgery | Bio-oss |
Primary outcome
Buccal-palatal thickness
Time frame: 18 months
1 secondary outcome
Oral-health related quality of life
Time frame: 18 months
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 11 May 2022.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immediate dentoalveolar restoration and Demineralized bovine bone in people with Fresh Sockets With Buccal Resorption, run by Federal University of Rio Grande do Sul at 1 site in Uruguay.
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 1 inclusion and 1 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 11 May 2022. 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 Uruguay. 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?
Buccal-palatal thickness (time frame: 18 months). 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 11 May 2022.