NCT05669118

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2021

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

December 8, 2022

Completed
22 days until next milestone

First Posted

Study publicly available on registry

December 30, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 2, 2023

Completed
Last Updated

April 26, 2024

Status Verified

April 1, 2024

Enrollment Period

2.3 years

First QC Date

December 8, 2022

Last Update Submit

April 25, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

  • Periodontal probing pocket depth

    Periodontal probing pocket depth in mm

    6 months after

Secondary Outcomes (1)

  • Patients satisfaction after treatment

    6 months after the reception of the treatment

Study Arms (2)

Autotransplantation

Patients who receive one tooth autotransplanted.

Procedure: Tooth Autotransplantation

Immediate implant

Patients who receive one inmediate dental implant.

Procedure: Immediate implant

Interventions

Place another tooth in the place of the newly extracted tooth in the same patient.

Also known as: Dental autotransplant
Autotransplantation

Place a dental implant immediately after tooth extraction.

Also known as: Type 1 implant
Immediate implant

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • Unavailability of a candidate donor tooth
  • Refusal of proposed treatment of dental autotransplantation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clínica Dental Esteve

Alicante, 03001, Spain

Location

MeSH Terms

Interventions

Immediate Dental Implant Loading

Intervention Hierarchy (Ancestors)

Dental Implantation, EndosseousDental ImplantationOral Surgical Procedures, PreprostheticOral Surgical ProceduresSurgical Procedures, OperativeProsthesis ImplantationDentistryProsthodontics

Study Officials

  • Guillem Esteve-Pardo, PhD

    Clínica Dental Esteve

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 8, 2022

First Posted

December 30, 2022

Study Start

May 1, 2021

Primary Completion

September 1, 2023

Study Completion

September 2, 2023

Last Updated

April 26, 2024

Record last verified: 2024-04

Locations