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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05669118
Other study ID # PROSP AUTO
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 1, 2021
Est. completion date September 2, 2023

Study information

Verified date April 2024
Source Aula Dental Avanzada
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 29
Est. completion date September 2, 2023
Est. primary completion date September 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - Unavailability of a candidate donor tooth - Refusal of proposed treatment of dental autotransplantation

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Tooth Autotransplantation
Place another tooth in the place of the newly extracted tooth in the same patient.
Immediate implant
Place a dental implant immediately after tooth extraction.

Locations

Country Name City State
Spain Clínica Dental Esteve Alicante

Sponsors (1)

Lead Sponsor Collaborator
Aula Dental Avanzada

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Soft tissue volume changes Soft tissue volume changes in the buccal side of the site in mm3 2 times measurement: day 0 and 6 months after
Primary Periodontal probing pocket depth Periodontal probing pocket depth in mm 6 months after
Secondary 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". 6 months after the reception of the treatment
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