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Premolar Autotransplantation in Juvenile Dentition: Quantitative Assessment of Vertical Bone and Soft Tissue Growth

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ClinicalTrials.gov Identifier: NCT02740907
Recruitment Status : Completed
First Posted : April 15, 2016
Last Update Posted : April 15, 2016
Sponsor:
Information provided by (Responsible Party):
Dirk Nolte, MD DDS PhD, MKG-Praxisklinik

Brief 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. 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.


Condition or disease Intervention/treatment
Traumatic Dental Injury Tooth Aplasia Procedure: premolar autotransplantation

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Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Premolar Autotransplantation in Juvenile Dentition: Quantitative Assessment of Vertical Bone and Soft Tissue Growth
Study Start Date : August 2012
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Intervention Details:
  • Procedure: premolar autotransplantation
    Autogenous tooth transplantation of premolars to the anterior maxilla to stimulate bone and soft tissue growth.


Primary Outcome Measures :
  1. Transplant survival [ Time Frame: 2006-2014 ]
    Evaluation by Kaplan-Meier-Estimator.

  2. Soft tissue development [ Time Frame: 2006-2014 ]
    Measurement by standardized clinical documentation.

  3. Bone development [ Time Frame: 2006-2014 ]
    Measurement by radiographic evaluation.

  4. Sensibility [ Time Frame: 2006-2014 ]
    Assessment of clinical sensibility.

  5. Root resorptions [ Time Frame: 2006-2014 ]
    Radiographic evaluation.

  6. Pulp obliteration [ Time Frame: 2006-2014 ]
    Radiographic evaluation.



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Ages Eligible for Study:   10 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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).
Criteria

Inclusion Criteria:

  • premolar transplantation after tooth loss in the anterior maxilla (13-23) by aplasia or trauma

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02740907


Locations
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Germany
MKG Praxisklinik
Munich, Sauerbruchstraße 48, Germany, 81377
Sponsors and Collaborators
MKG-Praxisklinik

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Responsible Party: Dirk Nolte, MD DDS PhD, MKG-Praxisklinik
ClinicalTrials.gov Identifier: NCT02740907     History of Changes
Other Study ID Numbers: Premolar transplantation
First Posted: April 15, 2016    Key Record Dates
Last Update Posted: April 15, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No