Bone Loss, AlveolarNCT03927937
Tooth Autotransplantation and Bone Dimension Changes
A study testing AUTOTRANSPLANTATION TOOTH in people with Bone Loss, Alveolar and Tooth Loss, run by Universidad de Murcia at 1 site in Spain.
Trial summary
Tooth autotransplantation is a treatment option to replace tooth with imposible prognosis. In several cases the receipt site has a reduced bone dimension. This situation may be imposible the treatment with dental implants without bone reconstruction. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Bone Loss, Alveolar, Tooth Loss, Bone Atrophy, Alveolar
- What is being tested?
- AUTOTRANSPLANTATION TOOTH
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- 5 Dec 2018to 30 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Tooth with imposible prognosis
- Plaque index score less than 30%
- No relevant systemic disease
- Smokers (Less than 20 cigars/day)
Who cannot join
- Pregnancy-Lactation
- Relevant systemic disease
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Universidad de Murcia
Murcia, 30003
Miguel Ramón PECCI LLORET, 630492610, miguelr.pecci@gmail.com
About this study
Official title: Tooth Autotransplantation and Bone Dimension Changes. Randomized Clinical Trial.
Tooth autotransplantation is a treatment option to replace tooth with imposible prognosis. In several cases the receipt site has a reduced bone dimension. This situation may be imposible the treatment with dental implants without bone reconstruction. Autotransplantation seem to improve the anatomic characteristic of the receipt site without any reconstruction approach.
The aim of this study is to evaluate the bone dimension changes followed autotransplantation treatment.
- Conditions
- Bone Loss, Alveolar, Tooth Loss, Bone Atrophy, Alveolar
- Being tested
- AUTOTRANSPLANTATION TOOTH
- Medical subject headings
- Alveolar Bone Loss, Tooth Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AUTOTRANSPLANTATION TOOTHProcedure or surgery
Tooth with imposible prognosis is replace with a healthy tooth from the same patient.
| Study group | Role | What they receive |
|---|---|---|
| AUTOTRANSPLANTATION TOOTH | Experimental | Not described Receives: Procedure: AUTOTRANSPLANTATION TOOTH |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in alveolar bone 12 months after tooth autotransplantation
CT-scan evaluation before surgery and 1 year after, measuring the difference in millimeters
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2019
- Study start5 Dec 2018
- Primary completion30 Dec 2019 (estimated)
- Study completion30 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone Loss, AlveolarStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francisco Javier Rodriguez Lozano, Universidad de Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03927937
- Sponsor's protocol ID
- 2015/2018
- Status last verified
- Apr 2019
- First submitted
- 20 Apr 2019
- Last updated
- 25 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tooth Autotransplantation and Bone Dimension Changes. Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT03927937
- Acronym / sponsor ID
- 2015/2018
- Conditions
- Bone Loss, Alveolar, Tooth Loss, Bone Atrophy, Alveolar
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Universidad de MurciaUniversity, hospital or other
- Study start
- 5 Dec 2018 (actual)
- Primary completion
- 30 Dec 2019 (estimated)
- Study completion
- 30 Jun 2020 (estimated)
- First posted
- 25 Apr 2019 (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.
Tooth autotransplantation is a treatment option to replace tooth with imposible prognosis. In several cases the receipt site has a reduced bone dimension. This situation may be imposible the treatment with dental implants without bone reconstruction. Autotransplantation seem to improve the anatomic characteristic of the receipt site without any reconstruction approach.
The aim of this study is to evaluate the bone dimension changes followed autotransplantation treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AUTOTRANSPLANTATION TOOTH | Experimental | Procedure: AUTOTRANSPLANTATION TOOTH |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Tooth with imposible prognosis
- Plaque index score less than 30%
- No relevant systemic disease
- Smokers (Less than 20 cigars/day)
Key exclusion criteria (2 listed)
- Pregnancy-Lactation
- Relevant systemic disease
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 |
|---|---|---|
| AUTOTRANSPLANTATION TOOTHTooth with imposible prognosis is replace with a healthy tooth from the same patient. | Procedure or surgery | AUTOTRANSPLANTATION TOOTH |
Primary outcome
Change in alveolar bone 12 months after tooth autotransplantation
Time frame: 1 year
CT-scan evaluation before surgery and 1 year after, measuring the difference in millimeters
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2019.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AUTOTRANSPLANTATION TOOTH in people with Bone Loss, Alveolar and Tooth Loss, run by Universidad de Murcia at 1 site in Spain.
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 2 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 25 Apr 2019. 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 Spain. 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 Miguel Ramón P Pecci Lloret, DDS (630492610, miguelr.pecci@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in alveolar bone 12 months after tooth autotransplantation (time frame: 1 year). 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 25 Apr 2019.