Dental Autotransplantation or Immediate Single Implant fo... | NCT05669118

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

NCT05669118

Sponsor

Aula Dental Avanzada

Status

Completed

Last Update Posted

Apr 26, 2024Actual

Enrollment

29Actual

Phase

Not provided

Conditions

Transplantation, Autologous
Autografts
Surgery, Oral

Interventions

Tooth Autotransplantation
Immediate implant

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2021Actual

Primary Completion Date

Sep 1, 2023Actual

Completion Date

Sep 2, 2023Actual

First Submitted Date

Dec 8, 2022

First Submission Date that Met QC Criteria

Dec 27, 2022

First Posted Date

Dec 30, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 25, 2024

Last Update Posted Date

Apr 26, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Guillem Esteve-Pardo, Principal Investigator, Aula Dental AvanzadaPrincipal Investigator

Lead Sponsor

Aula Dental AvanzadaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

29Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Autotransplantation		Patients who receive one tooth autotransplanted.	Procedure: Tooth Autotransplantation
Immediate implant		Patients who receive one inmediate dental implant.	Procedure: Immediate implant

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Tooth Autotransplantation	Procedure	Place another tooth in the place of the newly extracted tooth in the same patient.	Autotransplantation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Guillem Esteve-Pardo, PhD	Clínica Dental Esteve	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Clínica Dental Esteve		Alicante		03001	Spain

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Data will be shared upon reasonable request.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D057893	Immediate Dental Implant Loading

Ancestor Terms

ID	Term
D003758	Dental Implantation, Endosseous
D003757	Dental Implantation
D013516	Oral Surgical Procedures, Preprosthetic
D019647	Oral Surgical Procedures

Browse Leaves

Not provided

Browse Branches

Not provided