Transplantation, AutologousNCT05669118
Dental Autotransplantation or Immediate Single Implant for the Replacement of a Hopeless Molar.
An observational study of Transplantation, Autologous and Autografts, run by Aula Dental Avanzada at 1 site in Spain.
Trial summary
The aim of this comparative study is to know the differences between the soft tissue volume changes around the autotransplanted tooth and the dental implant placed immediately after the extraction of a posterior tooth. Patient-centered results will also be obtained after having received one or the other treatment. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Transplantation, Autologous, Autografts, Surgery, Oral
- What is being tested?
- Tooth Autotransplantation and Immediate implant
- Type of treatment
- Surgery or procedure
- How many people
- 29 participants
- Where
- 1 siteSpain
- Study dates
- 1 May 2021to 2 Sep 2023
- Phase
- Observational
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients who come to the clinic and need a tooth extracted.
Who may be able to join
- Patients in ASA-I health status
- Aged between 18 and 80 years,
- Present a tooth in need of extraction with a mature candidate donor tooth compatible with the recipient bed
- Acceptance of proposed treatment of dental autotransplantation
Who cannot join
- Unavailability of a candidate donor tooth
- Refusal of proposed treatment of dental autotransplantation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dental Autotransplantation or Immediate Single Implant for the Replacement of a Hopeless Molar: a Comparative Case Series Study.
The aim of this comparative study is to know the differences between the soft tissue volume changes around the autotransplanted tooth and the dental implant placed immediately after the extraction of a posterior tooth. Patient-centered results will also be obtained after having received one or the other treatment.
Read the detailed description
Dental autotransplantation has high levels of success in permanent teeth with open apex. The results of success in permanent teeth with closed apex are somewhat lower but sufficient to consider the treatment as a viable alternative and to extend the therapeutic range of the treatment to older ages.
The aim of this prospective observational investigation is to evaluate the dimensional and attachment changes that occur in the treated areas and in the autotransplanted teeth respectively of adult patients with permanent teeth with closed apex. All adult patients receiving a dental autotransplantation between the years 2022 and 2023 will be included.
Pre-treatment, volume and insertion parameters will be recorded before and one year after treatment. The comparison with the extraction and dental implant treatment will be made using the digital records that are usually obtained during the performance of this treatment. The comparison will be made with the same number of patients who have been recruited for the dental autotransplant treatment, and the volumetric changes that occur will also be analyzed.
The volume comparisons will be carried out using the Medit Link digital measurement software (Medit, Seoul, Republic of Korea) and data will be obtained and analyzed statistically in order to draw the appropriate conclusions.
- Conditions
- Transplantation, Autologous, Autografts, Surgery, Oral
- Being tested
- Tooth Autotransplantation, Immediate implant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tooth AutotransplantationProcedure or surgery
Also called Dental autotransplant
Place another tooth in the place of the newly extracted tooth in the same patient.
Immediate implantProcedure or surgery
Also called Type 1 implant
Place a dental implant immediately after tooth extraction.
| Study group | Role | What they receive |
|---|---|---|
| Autotransplantation | Patients who receive one tooth autotransplanted. Receives: Procedure: Tooth Autotransplantation | |
| Immediate implant | Patients who receive one inmediate dental implant. Receives: Procedure: Immediate implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Soft tissue volume changes
Soft tissue volume changes in the buccal side of the site in mm3
Measured: 2 times measurement: day 0 and 6 months after
Periodontal probing pocket depth
Periodontal probing pocket depth in mm
Measured: 6 months after
Secondary outcomes (1)
Patients satisfaction after treatment
Satisfaction assessed by Numeric Rating Scale (NRS) form 0 to 10, being 0 "not satisfied at all" and 10 "very satisfied".
Measured: 6 months after the reception of the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2022
- Study start1 May 2021
- Primary completion1 Sep 2023
- Study completion2 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transplantation, AutologousStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aula Dental Avanzada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guillem Esteve-Pardo, Aula Dental Avanzada
- Investigators
- Guillem Esteve-Pardo, PhD, Principal investigator, Clínica Dental Esteve
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05669118
- Sponsor's protocol ID
- PROSP AUTO
- Status last verified
- Apr 2024
- First submitted
- 8 Dec 2022
- Last updated
- 26 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data will be shared upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dental Autotransplantation or Immediate Single Implant for the Replacement of a Hopeless Molar: a Comparative Case Series Study.
- ClinicalTrials.gov ID
- NCT05669118
- Acronym / sponsor ID
- PROSP AUTO
- Conditions
- Transplantation, Autologous, Autografts, Surgery, Oral
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Aula Dental AvanzadaUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 2 Sep 2023 (actual)
- First posted
- 30 Dec 2022 (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 aim of this comparative study is to know the differences between the soft tissue volume changes around the autotransplanted tooth and the dental implant placed immediately after the extraction of a posterior tooth. Patient-centered results will also be obtained after having received one or the other treatment.
Detailed description
Dental autotransplantation has high levels of success in permanent teeth with open apex. The results of success in permanent teeth with closed apex are somewhat lower but sufficient to consider the treatment as a viable alternative and to extend the therapeutic range of the treatment to older ages.
The aim of this prospective observational investigation is to evaluate the dimensional and attachment changes that occur in the treated areas and in the autotransplanted teeth respectively of adult patients with permanent teeth with closed apex. All adult patients receiving a dental autotransplantation between the years 2022 and 2023 will be included.
Pre-treatment, volume and insertion parameters will be recorded before and one year after treatment. The comparison with the extraction and dental implant treatment will be made using the digital records that are usually obtained during the performance of this treatment. The comparison will be made with the same number of patients who have been recruited for the dental autotransplant treatment, and the volumetric changes that occur will also be analyzed.
The volume comparisons will be carried out using the Medit Link digital measurement software (Medit, Seoul, Republic of Korea) and data will be obtained and analyzed statistically in order to draw the appropriate conclusions.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Autotransplantation | – | Procedure: Tooth AutotransplantationPatients who receive one tooth autotransplanted. |
| Immediate implant | – | Procedure: Immediate implantPatients who receive one inmediate dental implant. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who come to the clinic and need a tooth extracted.
Key inclusion criteria (4 listed)
- Patients in ASA-I health status
- Aged between 18 and 80 years,
- Present a tooth in need of extraction with a mature candidate donor tooth compatible with the recipient bed
- Acceptance of proposed treatment of dental autotransplantation
Key exclusion criteria (2 listed)
- Unavailability of a candidate donor tooth
- Refusal of proposed treatment of dental autotransplantation
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 |
|---|---|---|
| Tooth AutotransplantationAlso: Dental autotransplantPlace another tooth in the place of the newly extracted tooth in the same patient. | Procedure or surgery | Autotransplantation |
| Immediate implantAlso: Type 1 implantPlace a dental implant immediately after tooth extraction. | Procedure or surgery | Immediate implant |
Primary outcome
Soft tissue volume changes
Time frame: 2 times measurement: day 0 and 6 months after
Soft tissue volume changes in the buccal side of the site in mm3
Periodontal probing pocket depth
Time frame: 6 months after
Periodontal probing pocket depth in mm
1 secondary outcome
Patients satisfaction after treatment
Time frame: 6 months after the reception of the treatment
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 26 Apr 2024.
- Individual participant dataSharing planned: Undecided. Data will be shared upon reasonable request.
Related trials for Transplantation, Autologous
Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
Multiple Myeloma
Recruiting
NIRAF-Guided Parathyroid Identification During Thyroidectomy
Hypocalcemia, Hypoparathyroidism
Not yet recruiting
Autologous Thymus Transplant in Children With Congenital Heart Disease: A Pilot Study
Congenital Heart Disease (CHD)
Not yet recruiting
Free Soft Tissue Grafts (FSTG) Using Autograft Palatal Donor Tissue vs. Xenograft Collagen Matrix (Zderm™)
Gingival Recession Localized Moderate, Dental Implant
Active, not recruitingPhase 2
Siltuximab to Decrease Symptom Burden After Autologous Stem Cell Transplantation for Patients With Multiple Myeloma and AL Amyloidosis
Multiple Myeloma, AL Amyloidosis
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.
Guillem Esteve-Pardo, PhD principal investigator
Clínica Dental Esteve
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Transplantation, Autologous and Autografts, run by Aula Dental Avanzada 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: finished, as of the sponsor's last update on 26 Apr 2024. 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?
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?
Soft tissue volume changes (time frame: 2 times measurement: day 0 and 6 months after). The study lists 2 primary outcomes in all. 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 26 Apr 2024.