Dental Autotransplantation or Immediate Single Implant for the Replacement of a Hopeless Molar.

April 25, 2024 updated by: Guillem Esteve-Pardo, Aula Dental Avanzada

Dental Autotransplantation or Immediate Single Implant for the Replacement of a Hopeless Molar: a Comparative Case Series Study.

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.

Study Overview

Detailed 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.

Study Type

Observational

Enrollment (Actual)

29

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Alicante, Spain, 03001
        • Clínica Dental Esteve

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients who come to the clinic and need a tooth extracted.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Autotransplantation
Patients who receive one tooth autotransplanted.
Place another tooth in the place of the newly extracted tooth in the same patient.
Other Names:
  • Dental autotransplant
Immediate implant
Patients who receive one inmediate dental implant.
Place a dental implant immediately after tooth extraction.
Other Names:
  • Type 1 implant

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Soft tissue volume changes
Time Frame: 2 times measurement: day 0 and 6 months after
Soft tissue volume changes in the buccal side of the site in mm3
2 times measurement: day 0 and 6 months after
Periodontal probing pocket depth
Time Frame: 6 months after
Periodontal probing pocket depth in mm
6 months after

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patients satisfaction after treatment
Time Frame: 6 months after the reception of the 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Guillem Esteve-Pardo, PhD, Clínica Dental Esteve

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2021

Primary Completion (Actual)

September 1, 2023

Study Completion (Actual)

September 2, 2023

Study Registration Dates

First Submitted

December 8, 2022

First Submitted That Met QC Criteria

December 27, 2022

First Posted (Actual)

December 30, 2022

Study Record Updates

Last Update Posted (Actual)

April 26, 2024

Last Update Submitted That Met QC Criteria

April 25, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • PROSP AUTO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Data will be shared upon reasonable request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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