NCT02740907|Completed
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Sponsor study identifier
observational
20
1 country
1
Study Start
August 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
October 2014
Actual (reported)Study Completion
October 2014
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2014
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 2012
Date type not reportedThis date has not been verified as actual or estimated.
October 2014
Actual (reported)October 2014
Actual (reported)March 22, 2016
Actual (reported)April 15, 2016
Actual (reported)Transplant survival
Evaluation by Kaplan-Meier-Estimator.
2006-2014
Soft tissue development
Measurement by standardized clinical documentation.
2006-2014
Bone development
Measurement by radiographic evaluation.
2006-2014
Sensibility
Assessment of clinical sensibility.
2006-2014
Root resorptions
Radiographic evaluation.
2006-2014
Pulp obliteration
Radiographic evaluation.
2006-2014
Autogenous tooth transplantation of premolars to the anterior maxilla to stimulate bone and soft tissue growth.
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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).
MKG Praxisklinik
Munich, Sauerbruchstraße 48, 81377, Germany
20 participants (actual enrollment reported by the registry).
First Submitted
March 22, 2016
First Posted
April 15, 2016
Study Start
August 2012
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
October 2014
Actual (reported)Study Completion
October 2014
Actual (reported)Last Updated
April 15, 2016
Record last verified: 2016-04
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Source: ClinicalTrials.gov.
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