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

Traumatic Dental Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02740907
• Other study ID #: Premolar transplantation
• Status: Completed
• Phase: N/A
• First received: March 22, 2016
• Last updated: April 12, 2016
• Start date: August 2012
• Est. completion date: October 2014

Study information

• Verified date: April 2016
• Source: MKG-Praxisklinik
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ministry of Health
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years to 17 Years

Eligibility

Inclusion Criteria:

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

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Tooth Aplasia
• Traumatic Dental Injury

Intervention

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

Locations

Country	Name	City	State
Germany	MKG Praxisklinik	Munich	Sauerbruchstraße 48

Sponsors (1)

Lead Sponsor	Collaborator
MKG-Praxisklinik

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Transplant survival	Evaluation by Kaplan-Meier-Estimator.	2006-2014	No
Primary	Soft tissue development	Measurement by standardized clinical documentation.	2006-2014	No
Primary	Bone development	Measurement by radiographic evaluation.	2006-2014	No
Primary	Sensibility	Assessment of clinical sensibility.	2006-2014	No
Primary	Root resorptions	Radiographic evaluation.	2006-2014	No
Primary	Pulp obliteration	Radiographic evaluation.	2006-2014	No