Traumatic Dental InjuryNCT02740907
Premolar Autotransplantation in Juvenile Dentition: Quantitative Assessment of Vertical Bone and Soft Tissue Growth
An observational study of Traumatic Dental Injury and Tooth Aplasia, run by MKG-Praxisklinik at 1 site in Germany.
Trial summary
Objective: Premolar autotransplantation represents an effective therapeutic option for the treatment of juvenile dentition in traumatic dental injury with tooth loss. Numerous studies report on the osteoinductive potency of the method, however, to date no quantitative data has been provided. Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Traumatic Dental Injury, Tooth Aplasia
- What is being tested?
- premolar autotransplantation
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2012to Oct 2014
- 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 10 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Patients (mean age 13.6, f:10, m:10) suffering from tooth loss in the anterior maxilla (13-23). Thirteen patients suffered from traumatic dental injury (TDI) with subsequent tooth loss (n=16 transplants). In 7 patients, aplasia of teeth in region 13 to 23 was present (n=10 transplants).
Who may be able to join
- premolar transplantation after tooth loss in the anterior maxilla (13-23) by aplasia or trauma
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Objective:
Premolar autotransplantation represents an effective therapeutic option for the treatment of juvenile dentition in traumatic dental injury with tooth loss. Numerous studies report on the osteoinductive potency of the method, however, to date no quantitative data has been provided. The objective of this prospective clinical study was to quantitatively assess the bone and soft tissue levels after autogenous premolar transplantation by clinical and radiographic parameters.
Read more
Materials/Methods:
In the study 26 premolars were transplanted in 20 patients after traumatic dental injury (n=10) or tooth aplasia (n=16) in the upper front. Standard clinical parameters were evaluated. Based on a standardized photo documentation, the relative soft tissue level was measured in comparison to the healthy adjacent teeth. Radiographic findings involved the evaluation of root resorption, pulp canal obliterations and the relative bone height. Patient satisfaction was determined using a standardized questionnaire.
- Conditions
- Traumatic Dental Injury, Tooth Aplasia
- Being tested
- premolar autotransplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
premolar autotransplantationProcedure or surgery
Autogenous tooth transplantation of premolars to the anterior maxilla to stimulate bone and soft tissue growth.
What is being measured
The primary outcome is the main question the study is designed to answer.
Transplant survival
Evaluation by Kaplan-Meier-Estimator.
Measured: 2006-2014
Soft tissue development
Measurement by standardized clinical documentation.
Measured: 2006-2014
Bone development
Measurement by radiographic evaluation.
Measured: 2006-2014
Sensibility
Assessment of clinical sensibility.
Measured: 2006-2014
Root resorptions
Radiographic evaluation.
Measured: 2006-2014
Pulp obliteration
Radiographic evaluation.
Measured: 2006-2014
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2016 (estimated)
- Study startAug 2012
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Dental InjuryStudies 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
- Retrospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- MKG-Praxisklinik
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dirk Nolte, MD DDS PhD, MKG-Praxisklinik
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02740907
- Sponsor's protocol ID
- Premolar transplantation
- Status last verified
- Apr 2016
- First submitted
- 22 Mar 2016
- Last updated
- 15 Apr 2016
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Premolar Autotransplantation in Juvenile Dentition: Quantitative Assessment of Vertical Bone and Soft Tissue Growth
- ClinicalTrials.gov ID
- NCT02740907
- Acronym / sponsor ID
- Premolar transplantation
- Conditions
- Traumatic Dental Injury, Tooth Aplasia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- MKG-PraxisklinikUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 15 Apr 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.
Objective:
Premolar autotransplantation represents an effective therapeutic option for the treatment of juvenile dentition in traumatic dental injury with tooth loss. Numerous studies report on the osteoinductive potency of the method, however, to date no quantitative data has been provided. The objective of this prospective clinical study was to quantitatively assess the bone and soft tissue levels after autogenous premolar transplantation by clinical and radiographic parameters.
Materials/Methods:
In the study 26 premolars were transplanted in 20 patients after traumatic dental injury (n=10) or tooth aplasia (n=16) in the upper front. Standard clinical parameters were evaluated. Based on a standardized photo documentation, the relative soft tissue level was measured in comparison to the healthy adjacent teeth. Radiographic findings involved the evaluation of root resorption, pulp canal obliterations and the relative bone height. Patient satisfaction was determined using a standardized questionnaire.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Patients (mean age 13.6, f:10, m:10) suffering from tooth loss in the anterior maxilla (13-23). Thirteen patients suffered from traumatic dental injury (TDI) with subsequent tooth loss (n=16 transplants). In 7 patients, aplasia of teeth in region 13 to 23 was present (n=10 transplants).
Key inclusion criteria (1 listed)
- premolar transplantation after tooth loss in the anterior maxilla (13-23) by aplasia or trauma
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| premolar autotransplantationAutogenous tooth transplantation of premolars to the anterior maxilla to stimulate bone and soft tissue growth. | Procedure or surgery | – |
Primary outcome
Transplant survival
Time frame: 2006-2014
Evaluation by Kaplan-Meier-Estimator.
Soft tissue development
Time frame: 2006-2014
Measurement by standardized clinical documentation.
Bone development
Time frame: 2006-2014
Measurement by radiographic evaluation.
Sensibility
Time frame: 2006-2014
Assessment of clinical sensibility.
Root resorptions
Time frame: 2006-2014
Radiographic evaluation.
Pulp obliteration
Time frame: 2006-2014
Radiographic evaluation.
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 15 Apr 2016.
- 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.
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?
An observational study of Traumatic Dental Injury and Tooth Aplasia, run by MKG-Praxisklinik at 1 site in Germany.
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 0 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 15 Apr 2016. 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 Germany. 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?
Transplant survival (time frame: 2006-2014). The study lists 6 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 15 Apr 2016.